Imagecast PACS with Centricity RIS-IC versions prior to 10.6 Update Package 18  Product Usage:  is an image management system intended to be used by trained professionals, including but not limited to physicians, nurses and medical technicians. The system is used with general purpose computing hardware to acquire, transmit, process and store images and data throughout a clinical environment. Data and images are acquired through DICOM compliant imaging devices and modalities. Lossy compressed mammographic images and digitized film screen images must not be reviewed for primary image interpretation. Mammographic images may only be interpreted using an FDA approved monitor that offers at least 5 Mpixel resolution and meets other technical specifications reviewed and accepted by the FDA.
A software defect was discovered that causes images to be out of context with clinical information.
Imagecast  PACS  3.5.69,  3.5.86,  3.5.87 and 3.6 with Centricity. RIS-IC 10.6 versions prior to update Package 18.
These feeds were shipped within Michigan.
Bulk turkey feed with designation: T110; a blend of designations T105 and T116
Reported turkey deaths suspected to have resulted after the turkeys consumed feeds containing high levels of the drug Lasalocid sodium.
Bulk turkey feed with designation: T114; a blend of designations T105 and T116
Bulk turkey feed with designation: T106; a blend of designations T105 and T116
Bulk turkey feed with designation: T113; a blend of designations T105 and T116
Flying Cow Creamery whole milk yogurt is recalled because the milk may not have been adequately pasteurized.
Batch #70   Best Before 12/3;    Milk from 11/3/14 was used to manufacturer Batch #70 with Best Before date of 12/3
Product was distributed to retail stores in northwest Iowa.
Casey's Bakery, Almond Patties, Traditional Dutch Puff Pastry Filled with Pure Almond Paste, 6 Patties, NET WT 13.5 OZ
The finished products were distributed to KS, MO, IL, NM, UT, AZ, and NV.  There was no foreign, military, or government distribution.
Cyclosporine-Corn Oil 1% Ophthalmic, packaged in 10-ml. containers, RX.  The firm name on the prescription label is Midwest Compounders Pharmacy, Lenexa, KS.
Potential for cross-contamination with penicillin
Demecarium Bromide 0.25%, packaged in 5-ml. containers, RX.  The firm name on the prescription label is Midwest Compounders Pharmacy, Lenexa, KS.
Demecarium Bromide 0.125% Ophthalmic, packaged in 5-ml. containers, RX.  The firm name on the prescription label is Midwest Compounders Pharmacy, Lenexa, KS.
Idoxuridine Drops 0.1% Ophthalmic, packaged in 10-ml. containers, RX.  The firm name on the prescription label is Midwest Compounders Pharmacy, Lenexa, KS.
Cyclosporine-Corn Oil 2% Ophthalmic, packaged in 10-ml. containers, RX.  The firm name on the prescription label is Midwest Compounders Pharmacy, Lenexa, KS.
Ice Nuggets, 10 lb plastic bag, UPC 3977919140.
Kwik Trip Inc reported a plastic fan broke which lead to pieces of plastic contaminating the ice.
U.S. distribution to the following; CA.  Products were distributed to two distribution centers for 7-Eleven and were further distributed to retail stores in Southern CA.    No foreign distribution.
7-ELEVEN  FRESH TO GO  OATMEAL RAISIN COOKIE  NET WT. 4.0 OZ  UPC: 052548558758
7-ELEVEN  FRESH TO GO  CHOCOLATE CHUNK COOKIE  NET WT. 4.0 OZ  UPC: 052548558741
Gastroscope    Product Usage:  Intended to provide optical visualization of and therapeutic access to the Upper Gastrointestinal Tract. This anatomy includes, but is not restricted to, the organs; tissues; and subsystems: Esophagus, Stomach and Duodenum. The instrument is introduced via the mouth when indications consistent with the need for procedure are observed in adult and pediatric patient populations.
Pentax Medical Video Processor EPK-i5010 has been shipped with a reusable Pentax Medical water bottle assembly (OS-H4) which has not been cleared for use with this devices in the United States.
Ultrasound Gastroscope    Product Usage:  Intended to provide optical visualization of, ultrasonic Visualization of, and therapeutic access to the Upper Gastrointestinal Tract including but not restricted to, the organs; tissues; and subsystems: Esophagus, Stomach, Duodenum, Small Bowel and underlying areas. The instrument is introduced via per orally when indications consistent with the requirement for procedure are observed in adult and pediatric patient populations.
Confocal GI Scope    Product Usage:  Intended to provide optical visualization of and therapeutic access to the Gastrointestinal Tract. This anatomy includes, but is not restricted to, the organs; tissues; and subsystems: Esophagus, Stomach, Duodenum, and Large Bowel to the Cecum. The instrument is introduced via the mouth or rectum as decided by the the anatomy being accessed when indications consistent with the need for procedure are observed in adult and pediatric patient populations.
Duodenoscope    Product Usage:  Intended to provide optical visualization of and therapeutic access to the Gastrointestinal Tract. This anatomy includes, but is not restricted to, the organs; tissues; and subsystems: Esophagus, Stomach, Duodenum, and Large Bowel to the Cecum. The instrument is introduced via the mouth or rectum as decided by the the anatomy being accessed when indications consistent with the need for procedure are observed in adult and pediatric patient populations.
Signmoidoscope    Product Usage:  Intended to provide optical visualization of, therapeutic access to the Lower Gastrointestinal Tract. This anatomy includes, but is not restricted to, the organs; tissues; and subsystems: Large Bowel to the Sigmoid Colon. The instrument is introduced via the rectum when indications consistent with the need for procedure are observed in adult and pediatric patient populations.
Colonoscope    Product Usage:  Intended to provide optical visualization of and therapeutic access to the Lower Gastrointestinal Tract. This anatomy includes, but is not restricted to, the organs; tissues; and subsystems: Large Bowel to the Cecum. The instrument is introduced via the rectum when indications consistent with the need for procedure are observed in adult and pediatric patient populations.
Organic Chopped Onions, Brand Bybee Foods, Net Wt 45 lb, UPC R02303    Organic Diced Onions, Brand Columbia River Organics, Net Wt 10 oz, UPC 5711000116    Diced Onions, Brand Northwest Grower's Select, Net Wt 45 lb, UPC 19190  Pearl Onions, Brand Northwest Growers Select, Net Wt 20 lb, UPC 22100    Organic Diced Onions, Brand Organic by Nature, Net Wt 45 lb, UPC AK#200064  Organic Diced Onions, Brand Organic by Nature, Net Wt 45 lb, UPC 202819    Raw Chopped Onions, Brand Farmer's Bounty, Net Wt 45 lb, UPC 26290     Chopped Onions, Brand Parade, Net Wt 12 oz, UPC 5070055791    Chopped Onion, Brand Signature Kitchens, Net Wt 12 oz, UPC 2113009049    Onion Cut, Brand Veggie Maria, Net Wt 500 g, UPC 543567006321    *******BULK containers***************    Organic Onions Diced, Brand Amy's, Net Wt 45 lb    Organic Onions Diced, Brand CH Belt, Net Wt 45    Organic Onions Diced, Brand Don Lee Farms, Net Wt 45    Organic Onions Diced, Happy Family/Nuture INC, Net Wt 1250    Organic Onions Diced, Brand Pacific Foods, Net Wt 45 lb  Organic Onions Diced, Pacific Foods, Net Wt 1250    Onions Diced, Brand Single Source, Net Wt 45 lb
Onions are recalled because they have the potential to be contaminated with Listeria monocytogenes.
All affected products have the best by dates or sell by dates between April 26, 2016 and April 26, 2018.    Farmer's Bounty Raw Chopped Onions have the code format 284523007721  08:36  Parade Chopped Onions have the code format Best By: 122215 281123001108 15:23) Product of USA A  Signature Kitchens Chopped Onion have the code format Best Before: Oct 23 17 S3904 15:08 B Product of USA  Veggie Maria Onion Cut have the code format 2016/01 20:55 B 103700201142
Cut Italian Beans, Brand Northwest Growers Select, Net Wt 20 lb, UPC 4635800031  Green Italian Beans, Brand Chef Maxwell, Net Wt 30 lb, UPC 3530295001      ***********BULK containers************    Italian Cut Beans, Brand JAG Foods/LA Foods, Net Wt 30 lb.    Italian Cut Beans, brand The Inn, Net wt. 20 lb.
Retail= 187,380 lbs. and BULK = 184,200 lbs.
Italian Beans are recalled because they have the potential to be contaminated with Listeria monocytogenes.
All affected products have the best by dates or sell by dates between April 26, 2016 and April 26, 2018.    Chef Maxwell Green Italian Beans have the code format Best By: 071616  203008009920   17:36
Organic Strawberries, Brand Columbia River Organics, Net Wt 10 oz, UPC 5711000131
Organic Strawberries are recalled because they have the potential to be contaminated with Listeria monocytogenes.
All affected products have the best by dates or sell by dates between April 26, 2016 and April 26, 2018.
Green Peas, Brand Bybee's Best, Net Wt 20 lb, UPC 4635800011  Green Peas, Brand Byee Foods, Net Wt 50 lb, UPC 155000007785CR  Organic Sweet Baby Peas, Brand Bybee Foods, Net Wt 5 lb, UPC 5711000145    Organic Petite Peas, Brand Columbia River Organics, Net Wt 10 oz, UPC 5711000109    Green Peas, Brand Northwest Growers Select, Net Wt 20 lb, UPC 5711000152  Green Peas, Brand Northwest Growers Select, Net Wt 55 lb, UPC 45721084  Organic Peas, Brand Northwest Growers Select, Net Wt 30 lb, UPC 5711000155    Organic Baby Peas, Brand Organic by Nature, Net Wt 16 oz, UPC 4635800069  Organic Green Peas, Brand Organic by Nature, Net Wt 50 lb, UPC R01790  Organic Sweet Baby Peas, Brand Organic by Nature, Net Wt 5 lb, UPC 4635800063  Organic Sweet Peas, Brand Organic by Nature, Net Wt 2.5 kg, UPC 4635800061    Peas, Brand Chef Maxwell, Net Wt 20 lb, UPC 051849  Green Peas, Brand Chef Maxwell, Net Wt 30 lb, UPC 3530295003    Green Peas, Brand Correct Choice, Net Wt 30 lb, UPC 30PBE    Peas, Brand Earth's Pride Organics, Net Wt 5 lb, UPC 0000027772    Peas, Brand Endico, Net Wt 20 lb, UPC 7720    Green Peas, Brand Farmers Bounty, Net Wt 30 lb, UPC 5711000161  Green Peas, Brand Farmer's Bounty, Net Wt 50 lb, UPC 4635800028    Green Peas, Fiesta Mart, Net Wt 16 oz, UPC 5102280005    Green Peas, Brand The Inn, Net Wt 20 lb, UPC 8628920742    Green Peas, Brand Live Smart, Net Wt 40 oz, UPC 603546    Green Peas, Brand Parade, Net Wt 16 oz, UPC 5070031666  Green Peas, Brand Parade, Net Wt 32 oz, UPC 5070007682  Petite Green Peas, Brand Parade, Net Wt 16 oz, UPC 5070055804    Green Peas, Brand O Organic, Net Wt 16 oz, UPC 7989340174    Green Peas, Brand Pantry Essentials, Net Wt 64 oz, UPC 2113015226    Green Peas, Brand Safeway Kitchens, Net Wt 32 oz, UPC 2113009029  Green Peas, Brand Signature Kitchens, Net Wt 16 oz, UPC 2113009028  Green Peas, Brand Signature Kitchens, Net Wt 32 oz, UPC 2113009029  Green Peas (NO SALT ADDED), Brand Signature Kitchens, Net Wt 16 oz, UPC 2113009031  Petite Green Peas, Brand Signature Kitchens, N
Peas are recalled because they have the potential to be contaminated with Listeria monocytogenes.
All affected products have the best by dates or sell by dates between April 26, 2016 and April 26, 2018.    Chef Maxwell Peas have the code format Best By: 071616  152000009920   17:31  Chef Maxwell Green Peas have the code format Best By: 071616  153000009920   17:37  Correct Choice Green Peas have the code format 153000007766  08:29  Earth's Pride Organics Peas have the code format Best By: 041218 103 16 23:01 B Product of USA 556700001122  Endico Peas have the code format 152000007709  08:31  Farmers Bounty Green Peas have the code format 152000007721   08:32  Farmer's Bounty Green Peas have the code format 155000007721  08:38  Fiesta Mart Green Peas	have the code format Best By: 122215 151200001178 15:23) Product of USA A  The Inn Green Peas have the code format 15200000111508:31  Live Smart Green Peas have the code format Product of USA 2B6101 02:11 B  Parade Green Peas have the code format Best By: 122215 151200001108 15:23) Product of USA A  Parade Green Peas have the code format Best By: 122215 151500001108 15:23) Product of USA A  Parade Petite Green Peas have the code format Best By: 122215 151210001108 15:23) Product of USA A  O Organic Green Peas have the code format Best Before: Oct 23 17 S3904 15:08 B Product of USA  Pantry Essentials Green Peas have the code format Best Before: Oct 23 17 S3904 15:08 B Product of USA  Safeway Kitchens Green Peas have the code format Best Before: Oct 23 17 S3904 15:08 B Product of USA  Signature Kitchens Green Peas have the code format Best Before: Oct 23 17 S3904 15:08 B Product of USA  Signature Kitchens Green Peas have the code format Best Before: Oct 23 17 S3904 15:08 B Product of USA  Signature Kitchens Green Peas (NO SALT ADDED) have the code format Best Before: Oct 23 17 S3904 15:08 B Product of USA  Signature Kitchens Petite Green Peas have the code format Best Before: Oct 23 17 S3904 15:08 B Product of USA  Signature Kitchens Petite Green Peas have the code format Best Before: Oct 23 17 S3904 15:08 B Product of USA  Signature Kitchens Sugar Snap Peas hav
Organic California Broccoli Florets, Brand Bybee Foods, Net Wt 4 lb, UPC 4635800050  Organic Broccoli Florets, Brand Columbia River Organics, Net Wt 10 oz, UPC 5711000117  Broccoli Cuts, Brand Northwest Growers Select, Net Wt 20 lb, UPC 4635800046  Organic California Broccoli Florets, Brand Organic by Nature, Net Wt 16 oz, UPC 4635800060  Organic Broccoli Florettes, Trader Joe's, Net Wt 16 oz, UPC 00542784  Organic Broccoli Florets, Brand True Goodness, Net Wt 10 oz, UPC 1373343097  Organic Broccoli Florets, Brand Wild Oats, Net Wt 10 oz, UPC 4873700377
Broccoli are recalled because they have the potential to be contaminated with Listeria monocytogenes.
All affected products have the best by dates or sell by dates between April 26, 2016 and April 26, 2018.    Trader Joe's Organic Broccoli Florettes have the code format Lot 115 16 BF 22:58 C Product of USA    True Goodness Organic Broccoli Florets have the code format Best By: 042318 16:30 D Product of USA                                                Wild Oats Organic Broccoli Florets have the code format Best By: 040918 15:15 A Product of USA
Organic Chopped Kale, Brand Bybee Foods, Net Wt 56 oz, UPC 4635800054  Organic Chopped Kale, Brand Organic by Nature, Net Wt 40 lb, UPC R02208  Chopped Kale, Brand O Organic, Net Wt 10 oz, UPC 7989340282  Organic Chopped Kale, Brand Wild Oats, Net Wt 10 oz, UPC 4873700379    *******BULK containers*****************    Organic Kale, Brand Pacific Foods, Net Wt. 40 lbs
Chopped Kale are recalled because they have the potential to be contaminated with Listeria monocytogenes.
All affected products have the best by dates or sell by dates between April 26, 2016 and April 26, 2018.    O Organic Chopped Kale have the code format Best Before: Oct 23 17 S3904 15:08 B Product of USA  Wild Oats Organic Chopped Kale have the code format Best By: 040918 15:15 C  Product of USA
Organic Raspberries, Columbia River Organics, Net Wt 10 oz, UPC 5711000130
Organic Raspberries are recalled because they have the potential to be contaminated with Listeria monocytogenes.
Chopped Spinach, Brand Bybee Foods Northwest Growers Select, Net Wt 56 oz, UPC 4635800035    Organic Spinach, Brand Columbia River Organics, Net Wt 10 oz, UPC 5711000121    Chopped Spinach, Brand Earth's Pride Organics, Net Wt 3.5 lb, UPC 0000027771    Organic Chopped Spinach, Brand Wellsley Farms, Net Wt 4 lb, UPC 8867001013    Organic Chopped Spinach, Brand True Goodness, Net Wt 10 oz, UPC 1373343101    Organic Chopped Spinach, Brand Wild Oats, Net Wt 10 oz, UPC 4873700380
Spinach are recalled because they have the potential to be contaminated with Listeria monocytogenes.
All affected products have the best by dates or sell by dates between April 26, 2016 and April 26, 2018.    Earth's Pride Organics Chopped Spinach have the code format Best By: 041218 103 16 23:01 B Product of USA 726623001122  Wellsley Farms Organic Chopped Spinach have the code format Best By: 041218 103 16 23:01 B Product of USA 746700001137  True Goodness Organic Chopped Spinach have the code format Best By: 042318 16:30 D Product of USA                                              Wild Oats Organic Chopped Spinach have the code format Best By: 040918 15:15 D Product of USA
Organic Edamame, Brand Columbia River Organics, Net Wt 10 oz, UPC 5711000120  Organic Shelled Edamame, Brand Columbia River Organics, Net Wt 10 oz, UPC 5711000119  Organic Edamame, Brand Organic by Nature, Net Wt 8 oz, UPC 4635800073  Edamame, Brand Live Smart, Net Wt 6 oz, UPC 604369  Edamame, Brand O Organic, Net Wt 16 oz, UPC 7989340179  Edamame, Brand Signature Kitchens, Net Wt 48 oz, UPC 2113009197  Shelled Edamame, Brand Signature Kitchens, Net Wt 16 oz, UPC 2113009092
Edamame are recalled because they have the potential to be contaminated with Listeria monocytogenes.    Live Smart Edamame have the code format Product of USA 2B6101 02:11 B  O Organic Edamame have the code format Best Before: Oct 23 17 S3904 15:08 B Product of USA  Signature Kitchens Edamame have the code format Best Before: Oct 23 17 S3904 15:08 B Product of USA  Signature Kitchens Shelled Edamame have the code format Best Before: Oct 23 17 S3904 15:08 B Product of USA
All affected products have the best by dates or sell by dates between April 26, 2016 and April 26, 2018.    Live Smart Edamame	6oz	604369	Product of USA                                                                       2B6101 02:11 B  O Organic Edamame	16oz	7989340179	Best Before: Oct 23 17 S3904 15:08                                  B Product of USA  Signature Kitchens Edamame	48oz	2113009197	Best Before: Oct 23 17 S3904 15:08                                  B Product of USA  Signature Kitchens Shelled Edamame	16oz	2113009092	Best Before: Oct 23 17 S3904 15:08                                  B Product of USA
Organic Blueberries, Brand Columbia River Organics, Net Wt. 10 oz, UPC 5711000125  Wild Blueberries, Brand O Organic, Net Wt. 10 oz, UPC 7989340654
Blueberries are recalls because they have the potential to be contaminated with Listeria monocytogenes.
All affected products have the best by dates or sell by dates between April 26, 2016 and April 26, 2018.    O Organic Wild Blueberries have the code format: Best Before: Oct 23 17 S3904 15:08 B Product of USA
Brussels Sprouts, Brand O Organic, Net Wt 10 oz, UPC 7989340283
Brussels Sprouts are recalled because they have the potential to be contaminated with Listeria monocytogenes.
All affected products have the best by dates or sell by dates between April 26, 2016 and April 26, 2018.    O Organic Brussels Sprouts have the code format Best Before: Oct 23 17 S3904 15:08 B Product of USA
Organic Steamers Sweet Potatoes, Brand Bybee Foods, Net Wt 12 oz, UPC 4635800052  Organic Sweet Potatoes, Brand Columbia River Organics, Net Wt 10 oz, UPC 4635800023  Organic Diced Sweet Potatoes, Brand Wild Oats, Net Wt 10 oz, UPC 4873700709    *******BULK containers***************    Sweet Potatoes, Brand CH Belt, Net Wt 1650
Organic Sweet Pototoes are recalled because they have the potential to be contaminated with Listeria monocytogenes.
All affected products have the best by dates or sell by dates between April 26, 2016 and April 26, 2018.    Wild Oats Organic Diced Sweet Potatoes have the code format Best  By: 040918 15:15 C Product of USA
Organic Sweet Cherries, brand Columbia River Organics, Net Wt 10 oz, UPC 5711000127
Organic Sweet Cherries are recalled because they have the potential to be contaminated with Listeria monocytogenes.
Organic Diced Leeks, Brand Organic by Nature, Net Wt 40 lb, UPC R01810D    *******BULK Containers*****************    Organic Leeks, Brand Pacific Foods, Net Wt. 40 lb
Organic Diced Leeks are recalled because they have the potential to be contaminated with Listeria monocytogenes.
Supersweet Cob Corn, Brand Northwest Growers Select, Net Wt 48 count, UPC 528628    Organic Super Sweet White Corn, Brand Organic by Nature, Net Wt 16 oz, UPC 4635800070  Organic Super Sweet Whole Kernel Corn, Brand Organic by Nature, Net Wt 50 lb, UPC R03881  Org White Corn, Brand Organic by Nature, Net Wt 4 lb, UPC 4635800070  Organic White Corn, Brand Organic by Nature, Net Wt 5 lb, UPC 4635800064  Whole Kernel Sweet Corn, Brand Organic by Nature Organic, Net Wt 4 lb, UPC 4635800058    Cut Corn, Brand Chef Maxwell, Net Wt 20 lb, UPC 051849  Cut Corn, Brand Chef Maxwell, Net Wt 30 lb, UPC 3530295002    Cut Corn, Brand Correct Choice, Net Wt 30 lb, UPC 30CBE    Cut Corn, Brand Endico, Net Wt 20 lb, UPC 601459277304    Cut Corn, Brand Farmer's Bounty, Net Wt 20 lb, UPC 02300  Corn, Brand Farmer's Bounty, Net Wt 30 lb, UPC 5711000171    Cut Corn, Brand Fiesta Mart, Net Wt 16 oz, UPC 5102280003    Cut Corn, Brand The Inn, Net Wt 20 lb, UPC 8628920723    Organic Super Sweet Yellow and White Corn, Brand Live Smart, Net Wt 16 oz, UPC 604338  Super Sweet Cut Corn, Brand Live Smart, Net Wt 40 oz, UPC 603379    Cut Corn, Brand Parade, Net Wt 16 oz, UPC 5070030666  Cut Corn, Brand Parade, Net Wt 32 oz, UPC 5070007676    Golden Cut Corn, Brand O Organic, Net Wt 16 oz, UPC 7989340175  Org SS Corn, Brand O Organics, Net Wt 16 oz, UPC 7989340175    Super Sweet Corn, Brand Panda Express, Net Wt 20 lb, UPC 07913    Cut Corn, Brand Pantry Essentials, Net Wt 64 oz, UPC 2113015225    Super Sweet Corn, Brand Safeway Kitchens, Net Wt 12 oz, UPC 2113009065    Sweet Corn, Brand Signature Kitchens, Net Wt 12 oz, UPC 2113009065  White Sweet Corn, Brand Signature Kitchens, Net Wt 12 oz, UPC 2113009035  White Sweet Corn, Brand Signature Kitchens, Net Wt 16 oz, UPC 2113024254  Whole Kernel Corn, Brand Signature Kitchens, Net Wt 16 oz, UPC 2113009152  Whole Kernel Corn, Brand Signature Kitchens, Net Wt 32 oz, UPC 2113009021    Organic Super Sweet Cut Corn, Brand Trader Joe's, Net Wt 16 oz, UPC 00299633    Cut Corn, Brand USDA, Net Wt 30
Corn are recalled because they have the potential to be contaminated with Listeria monocytogenes.
All affected products have the best by dates or sell by dates between April 26, 2016 and April 26, 2018.    Chef Maxwell Cut Corn have the code format Best By: 071616  102000009920  17:29    Chef Maxwell Cut Corn have the code format Best By: 071616  10300000992017:33    Correct Choice CutCorn	 have the code format 103000407766   08:26    Endico Cut Corn have the code format 102000007709  08:29    Farmer's Bounty Cut Corn have the code format 102000407721   08:26    Farmer's Bounty Corn have the code format 103000407721 08:30    Fiesta Mart Cut Corn have the code format Best By: 122215 101200201178 15:23 Product of USA A    The Inn Cut Corn have the code format 102000401115  08:29    Live Smart Organic Bi-color Corn have the code format Product of USA         2B6101 02:11 B    Live Smart Super Sweet Cut Corn have the code format Product of USA        2B6101 02:11 B    Parade Cut Corn have the code format Best By: 122215 10120020110815:23 Product of USA A    Parade Cut Corn have the code format Best By: 122215 101500201108 15:23 Product of USA A    O Organic Golden Cut Corn have the code format Best Before: Oct 23 17 S3904 15:08 B Product of USA    O Organics Org SS Corn have the code format Best Before: Oct 23 17 S3904 15:08 B Product of USA    Panda Express Super Sweet Corn have the code format Use By: 021415 BF 16:20                                         Pantry Essentials Cut Corn have the code format Best Before: Oct 23 17 S3904 15:08 B Product of USA    Safeway Kitchens Super Sweet Corn have the code format Best Before: Oct 23 17 S3904 15:08 B Product of USA    Signature Kitchens Sweet Corn have the code format Best Before: Oct 23 17 S3904 15:08 B Product of USA    Signature Kitchens White Sweet Corn have the code format Best Before: Oct 23 17 S3904 15:08 B Product of USA    Signature Kitchens White Sweet Corn have the code format Best Before: Oct 23 17 S3904 15:08 B Product of USA    Signature Kitchens Whole Kernel Corn have the code format Best Before: Oct 23 17 S3904 15:08 B Product of USA    Signatu
Baby Lima Beans, Brand Parade, Net Wt 16 oz, UPC 5070030670    Baby Lima Beans, Safeway Kitchens, Net Wt 20 oz, UPC 2113009144    Lima Beans, Brand Signature Kitchens, Net Wt 16 oz, UPC 2113009946  Lima Beans, Brand Signature Kitchens, Net Wt 20 oz, UPC 2113009944    Baby Lima Beans, Brand VIP, Net Wt 16 oz, UPC 7007701016    Baby Lima Beans, Brand Quirch, Net Wt 14 oz, UPC 6507260150  Baby Lima Beans, Brand Quirch, Net Wt 32 oz, UPC 6507260149
Lima Beans are recalled because they have the potential to be contaminated with Listeria monocytogenes.
All affected products have the best by dates or sell by dates between April 26, 2016 and April 26, 2018.    Parade Baby Lima Beans have the code format Best By: 122215 311200001108 15:23) Product of USA A  Signature Kitchens Lima Beans have the code format Best Before: Oct 23 17 S3904 15:08 B Product of USA  Signature Kitchens Lima Beans have the code format Best Before: Oct 23 17 S3904 15:08 B Product of USA  VIP Baby Lima Beans have the code format 3756 107 16 08:27 A USA/CANADA  Quirch Baby Lima Beans have the code format Sell By: 012515  15:15 Product of USA A                                               Quirch Baby Lima Beans have the code format Sell By: 012515  15:15 Product of USA B
Pepper Strips, Brand Signature Kitchens, Net Wt 14 oz, UPC 2113009100
Pepper Strips are recalled because they have the potential to be contaminated with Listeria monocytogenes.
All affected products have the best by dates or sell by dates between April 26, 2016 and April 26, 2018.    Signature Kitchens Pepper Strips have the code format Best Before: Oct 23 17 S3904 15:08 B Product of USA
Organic Peaches, Brand Columbia River Organics, Net Wt 10 oz, UPC 5711000129  Sliced Peaches, Brand O Organic, Net Wt 10 oz, UPC 7989340650
Organic Peaches are recalled because they have the potential to be contaminated with Listeria monocytogenes.
All affected products have the best by dates or sell by dates between April 26, 2016 and April 26, 2018.    O Organic Sliced Peaches have the code format Best Before: Oct 23 17 S3904 15:08 B Product of USA
Diced Carrots, Brand Northwest Growers Select, Net Wt 20 lb, UPC 20100  Organic Diced Carrots, Brand Northwest Growers Select, Net Wt 50 lb, UPC 4635800019  Shoestring Carrots, Brand Northwest Growers Select, Net Wt 20 lb, UPC 4635800027  Organic Diced Carrots, Brand Organic by Nature , Net Wt 50 lb, UPC 20191  Carrots, Brand Chef Maxwell, Net Wt 30 lb, UPC 635302-5004  Diced Carrots, Brand Farmer's Bounty, Net Wt 50 lb, UPC 4635800029  Slice Carrots, Brand Farmer's Bounty, Net Wt 30 lb, UPC 463580008  Diced Carrots, Brand The Inn, Net Wt 20 lb, UPC	8628920742  Crinkle Cut Carrots, Brand Parade, Net Wt 16 oz, UP 5070030668  Crinkle Cut Carrots, Brand Safeway Kitchens, Net Wt 24 oz, UPC 2113009109  Crinkle Cut Carrots, Brand Signature Kitchens, Net Wt 16 oz, UPC 2113009945  Crinkle Cut Carrots, Brand Signature Kitchens, Net Wt 24 oz, UPC 2113009945    *******BULK containers***************    Organic Carrots, Brand Hain, Net Wt 1250 lb    Carrots, Brand MRB Foods Sources, Net Wt 50 lb    Organic Carrots, Brand Pacific Foods, Net Wt 50 lb  Organic Carrots, Brand Pacific Foods, Net Wt 1600 lb    Organic Carrots, Brand Primal Pet Food Inc, Net Wt 50 lb  Organic Carrots, Brand Primal Pet Food Inc, Net Wt 1500 lb
Carrots are recalled because they have the potential to be contaminated with Listeria monocytogenes.
All affected products have the best by dates or sell by dates between April 26, 2016 and April 26, 2018.    Chef Maxwell Carrots have the code format Best By: 071616  254000009920  17:40    Farmer's Bounty Diced Carrots have the code format 255020004421  08:37    Farmer's Bounty Slice Carrots have the code format 4635800008  08:37    The Inn Diced Carrots have the code format 252020001115 08:32    Parade Crinkle Cut Carrots have the code format Best By: 122215 251235001108 15:23 Product of USA A    Safeway Kitchens Crinkle Cut Carrots have the code format Best Before: Oct 23 17 S3904 15:08 B Product of USA    Signature Kitchens Crinkle Cut Carrots have the code format Best Before: Oct 23 17 S3904 15:08 B Product of USA    Signature Kitchens Crinkle Cut Carrots have the code format Best Before: Oct 23 17 S3904 15:08 B Product of USA
Cut Green Beans, Brand Overhill Farms, Net Wt 30 lb, UPC 0931140     Cut Green Beans, Brand Pantry Essentials, Net Wt 12 oz, UPC 2113015221  Cut Green Beans, Brand Pantry Essentials, Net Wt 32 oz, UPC 2113015155    Cut Green Beans, Brand Parade, Net Wt 16 oz, UPC 5070028672  Cut Green Beans, Brand Parade, Net Wt 32 oz, UPC 5070055810    Cut Green Beans, Brand Safeway Kitchens, Net Wt 16 oz, UPC 2113009151  Cut Green Beans, Brand Safeway Kitchens, Net Wt 32 oz, UPC 2113009083  Whole Petite Green Beans, Brand Safeway Kitchens, Net Wt 12 oz, UPC 2113009005    Cut Green Beans, Brand Signature Kitchens, Net Wt 16 oz, UPC 2113009151  Cut Green Beans, Brand Signature Kitchens, Net Wt 32 oz, UPC 2113009083  French Cut Green Beans, Brand Signature Kitchens, Net Wt 16 oz, UPC 2113009082  Whole Green Beans, Brand Signature Kitchens, Net Wt 16 oz, UPC 2113024256  Whole Green Beans, Brand Signature Kitchens, Net Wt 12 oz, UPC 2113009005    Cut Green Beans, Brand The Inn, Net Wt 20 lb, UPC 8628920109  Whole Green Beans, Brand The Inn, Net Wt 2 lb, UPC 8628920112    Organic Whole Green Beans, Brand Trader Joe's, Net Wt 16 oz, UPC 00169219    Organic Cut Green Beans, Brand True Goodness, Net Wt 10 oz, UPC 1373343095    Cut Green Beans, Brand USDA, Net Wt 30 lb, UPC 203050004407    Cut Green Beans, Brand VIP, Net Wt 32 oz, UPC 7007701208    Organic Cut Green Beans, Brand Wild Oats, Net Wt 12 oz, UPC 4873700713     ***********BULK
Retails = 33,759,454 lbs and BULK = 15,498,593 lbs.; BULK 1/2 inch green beans = 67,200 lbs.
Green Beans are recalled because they have the potential to be contaminated with Listeria monocytogenes.
Cut Green Beans have the code format 203017001168  08:29  Pantry Essentials Cut Green Beans have the code format Best Before: Oct 23 17 S3904 15:08 B Product of USA  Pantry Essentials Cut Green Beans have the code format Best Before: Oct 23 17 S3904 15:08 B Product of USA  Parade Cut Green Beans have the code format Best By: 122215 201250001108 15:23) Product of USA A  Parade Cut Green Beans have the code format Best By: 122215 20155000110815:23) Product of USA A  Safeway Kitchens Cut Green Beans have the code format Best Before: Oct 23 17 S3904 15:08 B Product of USA  Safeway Kitchens Cut Green Beans have the code format Best Before: Oct 23 17 S3904 15:08 B Product of USA  Safeway Kitchens Whole Petite Green Beans have the code format Best Before: Oct 23 17 S3904 15:08 B Product of USA  Signature Kitchens Cut Green Beans have the code format Best Before: Oct 23 17 S3904 15:08 B Product of USA  Signature Kitchens Cut Green Beans have the code format Best Before: Oct 23 17 S3904 15:08 B Product of USA  Signature Kitchens French Cut Green Beans have the code format Best Before: Oct 23 17 S3904 15:08 B Product of USA  Signature Kitchens Whole Green Beans have the code format Best Before: Oct 23 17 S3904 15:08 B Product of USA  Signature Kitchens Whole Green Beans have the code format Best Before: Oct 23 17 S3904 15:08 B Product of USA  The Inn Cut Green Beans have the code format 202050001115  08:30  Trader Joe's Organic Whole Green Beans have the code format Lot 115 16 BF 22:58 C Product of USA  True Goodness Organic Cut Green Beans have the code format Best By: 042318 16:30 D Product of USA                                              USDA Cut Green Beans have the code format 203050004407 08:27  VIP Cut Green Beans have the code format 3756 107 16 08:27 A  USA/CANADA  Wild Oats Organic Cut Green Beans	 have the code format Best  By: 040918 15:15 A Product of USA
Organic Cranberries, Brand Columbia River Organics, Net Wt 10 oz, UPC 4635800026.
Organic Cranberries are recalled because they have the potential to be contaminated with Listeria monocytogenes.
Organic Butternut Squash, Brand Columbia River Organics, Net Wt 10 oz, UPC 5711000141  Organic Butternut Squash, Brand Organic by Nature, Net Wt 16 oz, UPC 4635800075  Organic Butternut Squash, Brand Organic by Nature, Net Wt 2 kg, UPC 4635800067  Butternut Squash, Brand O Organic, Net Wt 10 oz, UPC 7989340281  Organic Diced Butternut Squash, Brand Wild Oats, Net Wt 10 oz, UPC 4873700710
Butternut Squash are recalled because they have the potential to be contaminated with Listeria monocytogenes.
All affected products have the best by dates or sell by dates between April 26, 2016 and April 26, 2018.    O Organic Butternut Squash have the code format Best Before: Oct 23 17 S3904 15:08 B Product of USA    Wild Oats Organic Diced Butternut Squash have the code format Best  By: 040918 15:15 B Product of USA
Organic Multi-Colored Cauliflower Florets, Brand Organic by Nature, Net Wt 16 oz, UPC 4635800076
Organic Multi-Colored Cauliflower Florets are recalled because they have the potential to be contaminated with Listeria monocytogenes.
Sunflower Seeds, PLU# 65167;   various weights; various sell by dates;  Market District;   Distributed by Giant Eagle, Pittsburgh, PA 15238
total for bulk and repacked containers (cannot be separated) 2197.53 lbs.
Giant Eagle supplier SunOpta has informed Giant Eagle of the expansion of their sunflower kernel recall due to possible Listeria monocytogenes contamination. Giant Eagle repacked the sunflower kernels under the Market District label, which were sold in the bulk section of 12 of its Market District stores. Giant Eagle has expanded their recall to include all lots of sunflower seeds
Product distributed to medical facilities in the following US states: AL, AZ, CA, CO, CT, FL, IA, IL, KS, LA, MA, MD, MN, NC, OH, PA, PR, TN, TX, UT, and WA. Product was also distributed internationally to the following countries: Australia, Canada, Dominican Republic, Malaysia, Turkey, and United Kingdom
Dual Chamber Container fill with gravity/attached transfer sets, 250 mL / 1250 mL, 300 mL / 1700 mL, 500 mL / 2500 mL, 500 mL / 3500 mL
An issue was identified after a redesign of the auto compounding device. The compounder cannot meet the designed accuracy specification when dispensing into bags. After reviewing the initial design of the device, it was determined the dispensing volume validation was not properly done and none of the compounders on the market can meet the stated specifications.
All lots are being recalled. Lot code consists of the five digit product code followed by a dash followed by a unique five character numeric or alphanumeric sequence. Affected product codes for this product: 66617, 66622, 66632, 66642, 69616, 69621, 69631, and 69641
Container fill and transfer sets, automatic fill compatible, 250 mL, 500 mL, 1000 mL, 1500 mL, 2000 mL, 3000 mL, or 4000 mL.
All lots are being recalled. Lot code consists of the five digit product code followed by a dash followed by a unique five character numeric or alphanumeric sequence. Affected product codes for this product: 58740, 58741, 58742, 58749, 58750, 58753, 58754
AUTOCOMP6 XPS High Speed Compounder REF 58810
Container fill and transfer sets, 250 mL and 500 mL, .    .
All lots are being recalled. Lot code consists of the five digit product code followed by a dash followed by a unique five character numeric or alphanumeric sequence. Affected product codes for this product: 66505 and 66510
Dual Chamber Container fill and transfer sets, 250 mL / 1250 mL or 500 mL / 2500 mL
All lots are being recalled. Lot code consists of the five digit product code followed by a dash followed by a unique five character numeric or alphanumeric sequence. Affected product codes for this product: 58733 and 58734
Container fill and transfer sets, 250 mL, 500 mL, 1000 mL, 2000 mL, 3000 mL, or 4000 mL.
AUTOCOMP6 XP High Speed Compounder REF 58810
Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Harris Teeter Organics Corn, 16oz bags (product labeling not available).
Potential contamination with Listeria monocytogenes.
Harris Teeter Organics Mixed Vegetables, 16oz bags (product labeling not available).
Mix Vegetables, brand JFDA (label in Japanese), frozen, net wt. 1 kg., UPC 991438945321    Mixed Vegetables, brand Mountain Mist, frozen, net wt. 1 kg., UPC 4635800055    The ingredients statement declares: Carrots, Corn, and Peas.
Mixed Vegetables (contains Carrots, Corn, and Peas) are recalled because they have the potential to be contaminated with Listeria monocytogenes.
All affected products have the best by dates or sell by dates between April 26, 2016 and April 26, 2018.    These products have a code format:     JFDA Mix Vegetables have the code format Use By: 20160924 351900007731 16:20 Product of USA A  Mountain Mist Mixed Vegetables have the code format Use By: 20150512 351900007738 16:20 Product of USA D
Garden Blend Vegetables, brand O Organic, frozen, net wt. 16oz. UPC 7989310100    The ingredients statement declares: Broccoli, Carrots, Corn, and Soybeans.
Garden Blend Vegetables is recalled because it has the potential to be contaminated with Listeria monocytogenes.
All affected products have the best by dates or sell by dates between April 26, 2016 and April 26, 2018.     This product has the code format:     Best Before: Oct 23 17 S3904 15:08 B Product of USA
Stir Fry Vegetable, brand Signature Kitchens, frozen, net. wt. 16oz. UPC 2113009077    Stir Fry Vegetable, brand Signature Kitchens, frozen, net wt. 32oz. UPC 2113009186    The ingredients statement declares: Beans, Broccoli, Carrots, Celery, Onions, Peas, Peppers, and Water Chestnuts.
Stir Fry Vegetable is recalled because it has the potential to be contaminated with Listeria monocytogenes.
All affected products have the best by dates or sell by dates between April 26, 2016 and April 26, 2018.     These products have the code formats:     Signature Kitchens Stir Fry Vegetable has the code format Best Before: Oct 23 17 S3904 15:08 B Product of USA    Signature Kitchens Stir Fry Vegetable has the code format Best Before: Oct 23 17 S3904 15:08 B Product of USA
Harvest Vegetable Blend, brand Signature Kitchens, frozen, net wt. 12oz. UPC 2113024259    The ingredients statement declares: Broccoli, Carrots, Cauliflower, Corn, and Peppers.
Harvest Vegetable Blend is recalled because it has the potential to be contaminated with Listeria monocytogenes.
Organic Gardener's Blend, brand Columbia River Organics, frozen, net wt. 10oz. UPC 5711000114    Mixed Vegetable Blend, brand O Organic, frozen, net wt. 16oz. UPC 7989340182    Vegetable Blend, brand Pantry Essentials, frozen, net wt. 32oz. UPC 2113015151    Vegetable Blend, brand Pantry Essentials, frozen, net wt. 64oz. UPC 2113015227    Organic Vegetable Medley, brand Organic by Nature, frozen, net wt. 5lb. UPC 4635800066    Organic Vegetable Medley, brand Organic by Nature, frozen, net wt. 2.5kg. UPC 4635800062    Organic Mixed Vegetables, brand Bybee Foods, frozen, net wt. 5lb. UPC 4635800051    Organic Mixed Vegetables, brand Bybee Foods, frozen, net wt. 4lb. UPC 4635800053    Mixed Vegetables, brand Endico, frozen, net wt. 40oz. UPC 0145916610    Mixed Vegetables, brand Great Value, frozen, net wt. 12oz. UPC 7874205334    Mixed Vegetables, brand Great Value, frozen, net wt. 26oz. UPC 7874210907    Steamable Mixed Vegetables, brand Great Value, frozen, net wt. 12oz. UPC 7874208026    Mixed Vegetables, brand James Farm, frozen, net wt. 40oz. UPC 6069501542    Mixed Vegetables, brand Safeway Kitchens, frozen, net wt. 16oz. UPC 2113009153    Seamed Mixed Vegetables, brand Season's Choice, frozen, net wt. 12oz. UPC 4149820284    Mixed Vegetables (4-way), brand Signature Kitchens, frozen, net wt. 16oz. UPC 2113009153    Organic Mixed Vegetables, brand Simply Nature, frozen, net wt. 16oz. UPC 4149829655    Organic Mixed Vegetables, brand True Goodness, frozen, net wt. 10oz. UPC 1373343096    Organic Mixed Vegetables, brand Wellsley Farms, frozen, net wt. 4lb. UPC 8867000997    Organic Mixed Vegetables, brand Wild Oats, frozen, net wt. 12oz. UPC 4873700715    Org 4way, brand O Organics, frozen, net wt. 16oz. UPC 7989340182    Organic Foursome, brand Trader Joe's, frozen, net wt. 16oz. UPC 00959902    The ingredients statement declares: Beans, Carrots, Corn, and Peas.
Beans, Carrots, Corn, and Peas mixes are recalled because they have the potential to be contaminated with Listeria monocytogenes.
All affected products have the best by dates or sell by dates between April 26, 2016 and April 26, 2018.     These products have the code formats:     O Organic Mixed Vegetable Blend has the code format Best Before: Oct 23 17 S3904 15:08 B Product of USA    Pantry Essentials Vegetable Blend has the code format Best Before: Oct 23 17 S3904 15:08 B Product of USA    Pantry Essentials Vegetable Blend has the code format Best Before: Oct 23 17 S3904 15:08 B Product of USA    Endico Mixed Vegetables has the code format Sell By: 012515  15:15 Product of USA C                                                  Great Value Mixed Vegetables has the code format Best If Used By: 042318 B 23:02 Product of USA    Great Value MIxed Vegetables has the code format Best If Used By: 042318 C 23:02 Product of USA    Great Value Steamable Mixed Vegetables has the code format Best If Used By: 042318 A 23:02 Product of USA    James Farm Mixed Vegetables has the code format Sell By: 012515  15:15 Product of USA D                                                  Safeway Kitchens Mixed Vegetables has the code format Best Before: Oct 23 17 S3904 15:08 B Product of USA    Season's Choice Steamed Mixed Vegetables has the code format Best Before: 032518 B 15:15 Product of USA                                                Signature Kitchens Mixed Vegetables (4-way) has the code format Best Before: Oct 23 17 S3904 15:08 B Product of USA    Simpy Nature Organic Mixed Vegetables has the code format Sell By: 012515 15:15 Product of USA D                                                  True Goodness Organic Mixed Vegetables has the code format Best By: 042318 16:30 D Product of USA                                                Wellsley Farms Organic Mixed Vegetables has the code format Best By: 041218 103 16 23:01 B Product of USA 556700001137    Wild Oats Organic Mixed Vegetables has the code format Best By: 040918 15:15 D Product of USA                                                O Organics Org 4way has the code format Best Before: Oct 2
Organic Broccoli & Cheddar Cheese, brand Columbia River Organics, frozen, net wt. 10oz. UPC 5711000140    The ingredients statement declares: Broccoli and Cheddar Cheese.
Organic Broccoli & Cheddar Cheese is recalled because it has the potential to be contaminated with Listeria monocytogenes.
Organic Garden Stir Fry	, brand Columbia River Organics, frozen, net wt. 10oz. UPC 5711000124    The ingredients statement declares: Broccoli, Carrots, Onions, Peppers, and Zucchini.
Organic Garden Stir Fry is recalled because it has the potential to be contaminated with Listeria monocytogenes.
Supreme Fiesta Blend, brand VIP, frozen, net wt. 14oz. UPC 7007705009    The ingredients statement declares: Black Beans, Corn, Onions, and Peppers.
Supreme Fiesta Blend is recalled because it has the potential to be contaminated with Listeria monocytogenes.
All affected products have the best by dates or sell by dates between April 26, 2016 and April 26, 2018.     This product has the code format:     3756 107 16 08:27 A USA/CANADA
Organic Stir-Fry, brand Kirkland Signature, frozen, net wt. 4lb. UPC 9661910114    The ingredients statement declares: Beans, Broccoli, Carrots, Mushrooms, Onions, and Peppers.
Organic Stir Fry is recalled because it has the potential to be contaminated with Listeria monocytogenes.
All affected products have the best by dates or sell by dates between April 26, 2016 and April 26, 2018.     This product has the code format:     Best  By: 040918 15:15 B USA/Holland/Ecuador Certified Organic By WSDA
Red, Green and Yellow Pepper Strips, brand Safeway Kitchens, frozen, net wt. 14oz., UPC 2113009100    The ingredients statement declares: Red, Green, and Yellow Pepper Strips.
Red, Green, and Yellow Pepper Strips are recalled because they have the potential to be contaminated with Listeria monocytogenes.
All affected products have the best by dates or sell by dates between April 26, 2016 and April 26, 2018.     This product has the code format:                                        Best Before: Oct 23 17 S3904 15:08 B Product of USA
Peas & Carrots, brand Bybee's Best, frozen, net wt. 20lb. UPC 4635800013    Peas & Carrots, brand Chef Maxwell, frozen, net wt. 30lb. UPC 98020    Carrots and Peas, brand CH Belt, frozen, net wt. 20lb. UPC --    Organic Peas & Carrots, brand Columbia River Organics, frozen, net wt.10oz. UPC 5711000112    Peas and Carrots, brand Emerald Farms, frozen, net wt. 40oz. UPC 3765403673    Peas and Carrots, brand Endico, frozen, net wt.	20lb. UPC 7730    Peas and Carrots, brand Endico, frozen, net wt.	40oz. UPC 0145916730    Peas & Carrots, brand Farmer's Bounty, frozen, net wt. 30lb. UPC 4635800002    Peas & Carrots, brand Fiesta Mart, frozen, net wt. 16oz. UPC 5102280007    Peas & Carrots, brand Great Value, frozen, net wt. 12oz. UPC 7874205335    Peas & Carrots, brand James Farm, frozen, net wt. 40oz. UPC 6069501001    Peas and Carrots, brand JAG Foods/LA Foods, frozen, net wt. 30lb. UPC --    Peas & Carrots, brand Northwest Growers Select, frozen, net wt. 20lb. UPC 14100    Carrots & Peas, brand Panda Express, frozen, net wt. 20lb. UPC 10882210001309    Peas and Dice Carrots, brand Parade, frozen, net wt. 16oz. UPC 5070031831    Peas & Carrots, brand Quirch, frozen, net wt. 14oz. UPC 6507260152    Peas & Carrots, brand Quirch, frozen, net wt. 32oz. UPC 6507260151    Green Peas & Diced Carrots, brand Safeway Kitchens, frozen, net wt. 12oz. UPC 2113009182    Peas & Carrots, brand Signature Kitchens, frozen, net wt. 12oz. UPC 2113009182    Peas & Carrots, brand Signature Kitchens, frozen, net wt. 16oz. UPC 2113009154    Peas & Carrots, brand Signature Kitchens, frozen, net wt. 32oz. UPC 2113009033    Peas & Carrots, brand The Inn, frozen, net wt. 20lb. UPC 8628920749    Organic Peas & Shoestring Carrots, brand True Goodness, frozen, net wt.10oz.  UPC 0882077972    Peas & Carrots, brand VIP, frozen, net wt. 16oz. UPC 7007701068    The ingredients statement declares: Peas and Carrots.
Peas & Carrots are recalled because they have the potential to be contaminated with Listeria monocytogenes.
All affected products have the best by dates or sell by dates between April 26, 2016 and April 26, 2018.     These products have code formats:                                        Chef Maxwell Peas & Carrots have the code format Best By: 071616  303000009920   17:38    Emerald Farms Peas and Carrots have the code format Sell By: 012515 15:15 Product of USA C                                                Endico Peas and Carrots have the code format 302000007709 08:32    Endico Peas and Carrots have the code format Sell By: 012515 15:15 Product of USA D                                                  Farmer's Bounty Peas & Carrots have the code format 303000007721  08:34    Fiesta Mart Peas & Carrots have the code format Best By: 122215 301200001178 15:23 Product of USA A    Great Value Peas & Carrots have the code format Best If Used By: 042318 C 23:02 Product of USA    James Farm Peas & Carrots have the code format Sell By: 012515  15:15 Product of USA E                                                 Panda Express Carrots & Peas have the code format Use By: 021415 BF 16:20                                         Parade Peas and Dice Carrots have the code format Best By: 122215 3011200001108 15:23 Product of USA A    Quirch Peas & Carrots have the code format Sell By: 012515 15:15 Product of USA A                                                 Quirch Peas & Carrots have the code format Sell By: 012515  15:15 Product of USA B                                                  Safeway Kitchens Green Peas & Diced Carrots have the code format Best Before: Oct 23 17 S3904 15:08 B Product of USA    Signature Kitchens Peas & Carrots have the code format Best Before: Oct 23 17 S3904 15:08 B Product of USA    Signature Kitchens Peas & Carrots have the code format Best Before: Oct 23 17 S3904 15:08 B Product of USA    Signature Kitchens Peas & Carrots have the code format Best Before: Oct 23 17 S3904 15:08 B Product of USA    The Inn Peas & Carrots have the code format 302000001115  08:35    True Goodness Organic Pe
Asparagus, Corn & Carrots Blend, brand Signature Kitchens, frozen, net wt. 12oz. UPC 2113009181    The ingredients statement declares: Asparagus, Corn, and Carrots.
Asparagus, Corn, & Carrots are recalled because they have the potential to be contaminated with Listeria monocytogenes.
Organic Peas & Pearl Onions, brand Columbia River Organics, frozen, net wt. 10oz. UPC 5711000113    The ingredients statement declares: Peas and Pearl Onions.
Organic Peas & Pearl Onions are recalled because they have the potential to be contaminated with Listeria monocytogenes.
All affected products have the best by dates or sell by dates between April 26, 2016 and April 26, 2018.     This product has the code format:                                        Live Smart Organic Vegetable Medley has the code format Product of USA 2B6101 02:11 B
Organic California Harvest, brand Columbia River Organics, frozen, net wt. 10oz. UPC 5711000122    The ingredients statement declares: Broccoli, Carrots, Cauliflower, and Zucchini.
Organic California Harvest is recalled because it has the potential to be contaminated with Listeria monocytogenes.
Organic Mixed Vegetables with Shelled Edamame, brand Bybee Foods, frozen, net wt. 5lb. UPC 4635800001    Organic Vegetable Medley, brand Live Smart, frozen, net wt. 16oz. UPC 604345    Organic Vegetable medley With Shelled Edamame, brand Organic by Nature, frozen, net wt. 5lb. UPC 4635800065    The ingredients statement declares: Beans, Carrots, Corn, Peas, and Edamame.
Beans, Carrots, Corn, Peas, and Edamame mixes are recalled because they have the potential to be contaminated with Listeria monocytogenes.
Supreme Bean & Carrot Blend, brand VIP, frozen, net wt. 14oz. UPC 7007705002    The ingredient statement declares: Beans and Carrots.
Bean & Carrot blend is recalled because it has the potential to be contaminated with Listeria monocytogenes.
All affected products have the best by dates or sell by dates between April 26, 2016 and April 26, 2018.     This product has the code format:                                        3756 107 16 08:27 A USA/CANADA
Broccoli & Cauliflower, brand Wild Oats Organic, frozen, net wt. 10 oz., UPC 4873700711    The ingredients statement declares: Broccoli and Cauliflower.
Broccoli & Cauliflower are recalled because they have the potential to be contaminated with Listeria monocytogenes.
All affected products have the best by dates or sell by dates between April 26, 2016 and April 26, 2018.     This product has a code format: Best  By: 040918 15:15 B  Product of USA
Supreme Healthy Garden Blend, brand VIP, frozen, net wt. 14oz. UPC 7007705011    The ingredients statement declares: Broccoli, Carrots, Soybeans, Squash, and Zucchini.
Supreme Healthy Garden Blend is recalled because it has the potential to be contaminated with Listeria monocytogenes.
Mini Bow Tie Pasta and Vegetable Blend, brand Live Smart, frozen, net wt. 32oz. UPC 603232    The ingredients statement declares: Mini Bow Tie Pasta, Corn, Carrots, Peas, and Peppers.
Mini Bow Tie Pasta and Vegetable Blend is recalled because it has the potential to be contaminated with Listeria monocytogenes.
All affected products have the best by dates or sell by dates between April 26, 2016 and April 26, 2018.     This product has the code format:     Product of USA 2B6101 02:11 B
Stew Vegetables, brand Signature Kitchens, frozen, net wt. 16oz. UPC 2113009947    The ingredients statement declares: Carrots, Celery, Onions, and Potatoes.
Stew Vegetables are recalled because they have the potential to be contaminated with Listeria monocytogenes.
Organic Root Medley, brand Organic by Nature, frozen, net wt. 16oz. UPC 4635800074    The ingredients statement declares: Carrots, Parsnips, and Potatoes.
Organic Root Medley is recalled because it has the potential to be contaminated with Listeria monocytogenes.
Organic Steamers Roasted Red Potato & Vegetable Medley, brand Bybee Foods, frozen, net wt.12oz. UPC 4635800041    Roasted Red Potatoes and Vegetable Medley, brand Earth's Pride Organics, frozen, net wt. 12oz. UPC 00000229244    Organic Roasted Red Potato & Vegetable Medley, brand Wellsley Farms, frozen, net wt. 4lb., UPC 8867001014    Organic Bounty Blend, brand Columbia River Organics, frozen, net wt. 10oz. UPC 4635800024    The ingredients statement declares: Beans, Mushrooms, Peppers, and Potatoes.
Potoatoes, Beans, Peppers, and Mushrooms mixes are recalled because they have the potential to be contaminated with Listeria monocytogenes.
All affected products have the best by dates or sell by dates between April 26, 2016 and April 26, 2018.     These products have the code format:                                        Earth's Pride Organics Roasted Red Potatoes and Vegetable Medley has the code format Best By: 041218 103 16 23:01 B Product of USA 743829001122    Wellsley Farms Organic Roasted Red Potato & Vegetable Medley has the code format Best By: 041218 103 16 23:01 B Product of USA 176700401137
Organic Potato Medley, brand Columbia River Organics, frozen, net wt. 10oz. UPC 4635800025    The ingredients statement declares: Yukon Gold Potatoes, Red Potatoes, Russet Potatoes, Sea Salt, Black Pepper, Garlic Powder, and Canola Oil.
Organic Potato Medley is recalled because it has the potential to be contaminated with Listeria monocytogenes.
Supreme Garden Stir-Fry, brand VIP, frozen, net wt. 14oz. UPC 7007705010    The ingredients statement declares: Beans, Broccoli, Mushrooms, Onions, and Peppers.
Supreme Garden Stir-Fry is recalled because it has the potential to be contaminated with Listeria monocytogenes.
Big House Blend, brand Bybee's, frozen, net wt. 30lb. UPC AZ#85    Best Mixed Vegetables, brand Bybee's, frozen, net wt. 20lb. UPC 4635800014    California Blend, brand Chef Maxwell, frozen, net wt. 20lb. UPC 063027    Raw Mixed Vegetables, brand Chef Maxwell, frozen, net wt. 30lb. UPC 63530295005    4 Way, brand E. Boyd, frozen, net wt. 55lb. UPC --    4 Way, brand E. Boyd, frozen, net wt. 1600lb. UPC --    Potato 3 Way, brand E. Boyd, frozen, net wt. 30lb. UPC --    Mixed Vegetables, brand Farmer's Bounty, frozen, net wt. 20lb. UPC 02300    Mixed Vegetables, brand Farmer's Bounty, frozen, net wt. 30lb. UPC 4635800003    4 Way, brand JAG Foods/LA Foods, frozen, net wt. 30lb. UPC --    Mixed Vegetables, brand Life Foods, frozen, net wt. 1kg. UPC 903392007687    Mixed Vegetables, brand McCain, frozen, net wt. 500g. UPC 991438945222    Mixed Vegetables, brand McCain, frozen, net wt. 1kg. UPC 991438945123    Mixed Vegetables, brand McCain YGC, frozen, net wt. 1kg. UPC 991438945383    Mixed Vegetables, brand Northwest Growers Select, frozen, net wt. 20lb. UPC 4635800044    4 Way, brand Single Source, frozen, net wt. 30lb. UPC --    4-Way Mixed Vegetables, brand The Inn, frozen, net wt. 20lb. UPC 8628920720    5-Way Mixed Vegetables, brand The Inn, frozen, net wt. 20lb. UPC 8628920744    The ingredients statement declares: Mixed Vegetables.
Mixed Vegetables are recalled because they have the potential to be contaminated with Listeria monocytogenes.
All affected products have the best by dates or sell by dates between April 26, 2016 and April 26, 2018.     These products have the code formats:     Chef Maxwell California Blend has the code format Best By: 071616  352000009920  17:28                          Chef Maxwell Raw Mixed Vegetables has the code format Best By: 071616 403000009920  17:39    Farmer's Bounty Mixed Vegetables has the code format 402000007721  08:29    Farmer's Bounty Mixed Vegetables has the code format 403000007721  08:33    Life Foods Mixed Vegetables has the code format Use By: 20160924 351900007716 16:20 Product of USA A    McCain Mixed Vegetables has the code format Use By: 20160924 353400001189 16:20 Product of USA B    McCain Mixed Vegetables has the code format Use By: 20160924 351900007789 16:20 Product of USA A    McCain YGC Mixed Vegetables has the code format Use By: 20160924 351900007732 16:20 Product of USA A    The Inn 4-way Mixed Vegetables has the code format 402000001115 08:33    The Inn 5-way Mixed Vegetables has the code format 45200000111508:34
Mixed Vegetable, brand Emerald Farms, frozen, net wt. 40oz. UPC 3765403670    Mixed Vegetables, brand Fiesta Mart, frozen, net wt. 16oz. UPC 5102280006    Mixed Vegetables, brand Parade, frozen, net wt. 16oz. UPC 5070030675    Mixed Vegetables, brand Parade, frozen, net wt. 32oz. UPC 5070055832    Mixed Vegetables, brand Quirch, frozen, net wt. 14oz. UPC 6507260130    Mixed Vegetables, brand Quirch, frozen, net wt. 32oz. UPC 6507260129    Mixed Vegetables,brand Safeway Kitchens, frozen, net wt. 32oz. UPC 2113009042    Mixed Vegetables (4-way), brand Signature Kitchens, frozen, net wt. 32oz. UPC 2113009042    Mixed Vegetables (5-way), brand Signature Kitchens, frozen, net wt. 32oz. UPC 2113009042    Mixed Vegetables (5-way), brand Signature Kitchens, frozen, net wt. 12oz. UPC 2113024258    Mixed Vegetables, brand VIP, frozen, net wt. 16oz. UPC 7007701076    Mixed Vegetables, brand VIP, frozen, net wt. 32oz. UPC 7007701276    The ingredients statement declares: Beans, Carrots, Corn, and Lima Beans.
All affected products have the best by dates or sell by dates between April 26, 2016 and April 26, 2018.     These products have the code formats:     Emerald Farms Mixed Vegetables has the code format Sell By: 012515  15:15 Product of USA E                                                 Fiesta Mart Mixed Vegetables has the code format Best By: 122215 451200001178 15:23) Product of USA A    Parade Mixed Vegetables has the code format Best By: 122215 45150000110815:23) Product of USA A    Parade Mixed Vegetables has the code format Best By: 122215 451200001108 15:23) Product of USA A    Quirch Mixed Vegetables has the code format Sell By: 012515 15:15 Product of USA E                                                 Quirch Mixed Vegetables has the code format Sell By: 012515 15:15 Product of USA A                                                  Safeway Kitchens Mixed Vegetables has the code format Best Before: Oct 23 17 S3904 15:08 B Product of USA    Signature Kitchens Mixed Vegetables (4-way) has the code format Best Before: Oct 23 17 S3904 15:08 B Product of USA    Signature Kitchens Mixed Vegetables (5-way) has the code format Best Before: Oct 23 17 S3904 15:08 B Product of USA    Signature Kitchens Mixed Vegetables (5-way) has the code format Best Before: Oct 23 17 S3904 15:08 B Product of USA    VIP Mixed Vegetables has the code format 3756 107 16 08:27 A USA/CANADA    VIP Mixed Vegetables has the code format 3756 107 16 08:27 A USA/CANADA
Supreme Stir-Fry Sensation, brand VIP, frozen, net wt. 14oz. UPC 7007705027    The ingredients statement declares: Broccoli, Carrots, Peas, Soybeans, and Water Chestnuts.
Supreme Stir-Fry Sensation is recalled because it has the potential to be contaminated with Listeria monocytogenes.
The product was distributed in the United States and Sweden
MicroAire has initiated a limited recall (29 Units)on the Endotine Transbleph 3.5 (CFD-080-0167), Lot # 285373, due to minor mislabeling ( the front label is correct, but the side label lists an incorrect part number, i.e. CFD-080-0177).
Endotine Transbleph 3.5 (CFD-080-0167), Lot # 285373
The Hain Celestial Group, Inc. - Worldwide HQ
Products were distributed across the United States and Mexico.  The products also were available for purchase on the internet.
A potential for Listeria monocytogenes contamination was verified by the sunflower seed raw material supplier.
Rold Gold Honey Wheat Braided 10 oz. packaged in flexible plastic bag.
Potential to contain undeclared peanuts.
in the second and third position (example : x32xxxxxx)
30 count Home Town Favorite Variety Pack packaged as 30 single flexible plastic bags
20 count Baked & Popped Mix packaged as 20 single flexible plastic bags
Rold Gold Tiny Twists 1 oz., 2 oz., 16 oz., and 20 1/2 oz.; Rold Gold Original Pretzel Thins 4 oz. and 16 oz.; Rold Gold Sticks 16 oz. packaged in flexible plastic bags.
20 count SunChips & Rold Gold Mix packaged as 20 single flexible plastic bags
32 count Fun Times mix packaged as 32 single flexible plastic bags
30 count Baked and Popped Variety Pack packaged as 30 single flexible plastic bags
Worldwide Distribution - US Nationwide in the countries of Puerto Rico and Foreign distribution to the following countries: Australia, Brazil, Canada, Chile, China, Colombia, England, France, Germany, India, Italy, Japan, Mexico, Panama, Singapore, Spain, Poland and Venezuela.
VITROS Chemistry Products Ca Slides, GEN 29, REF/Product Code 145 0261, Unique Device Identifier No. 10758750009114 or 20758750009111, IVD -- Sales Unit: 300 slides/pack     Product Usage:  For in vitro diagnostic use only. VITROS Ca Slides quantitatively measure calcium (Ca) concentration in serum, plasma, and urine. Calcium measurements are used in the diagnosis and treatment of parathyroid disease, a variety of bone disorders, chronic renal disease and tetany (intermittent muscular contractions or spasms).
US: 27,625 sales units; Foreign: 4757 sales units
Ortho Clinical Diagnostics (OCD) confirmed a potential for biased calcium (Ca) results to be generated when using VITROS Ca Slides, GEN29, and the VITROS 250/350/950/5,1 FS, 4600 Chemistry System or the VITROS 5600 Integrated System.  An increase in negatively biased calcium results complaints prompted the investigation that identified this product issue.
Oxacillin for Injection, USP, 10 grams per pharmacy bulk package, Buffered - For IV Use, Sterile, Nonpyrogenic, Preservative-free, Rx Only, Mfd for Sagent Pharmaceuticals, Schaumberg, IL, 60196, USA, Made in India, NDC 25021-163-69
Presence of Particulate Matter; The firm received two product complaints for small, dark particulate matter identified in solution post reconstitution.
The lot contains undeclared milk allergen which was confirmed by FDA sampling and analysis.
The firm shipped to 28 U. S. consignees. No foreign consignees. See attached spreadsheet in email.
22 cases, 12 packages per case, 5.5 oz per package
SunOpta has expanded their voluntary recall of Sunflower Kernels due to the potential presence of Listeria monocytogenes.
Doritos Spicy Sweet Chili Flavored tortilla chips in 3 1/8 ounce bags
Guaranteed Fresh Date: August 9, UPC code: 28400-42119, Manufacturing Code: 2711 152 05, 2712 152 05
Cases were distributed nationwide.  No government or military distribution.
Armour Snackmaker Keebler Animals Crackers, Chocolate Icing with Natural and Artificial Flavors, Plain Icing which are packaged in 2.7oz packages; Unit UPC code 2781500240 .  There are 18 packages to a case, Case SKU 2781500240. The responsible firm name on the label is Armour-Eckrich Meats LLC, Cincinnati, OH 45240.
Product contains an ingredient which is being recalled from their supplier due to the potential of low levels of peanut residue.
Sustainable Community Development LLC dba SCD Probiotics
Distributed to NM, KS, HI, MI, CA, and Hong Kong.  No government or military distribution.
Xtra Immunity Brown Rice Antioxidant Probiotic Extract, a liquid packaged in a 500mL bottle.  UPC 184368000114. The responsible firm name on the label is SCD Probiotics, Kansas City, MO 64106.
The product is a dietary supplement with drug claims, making the product misbranded.
US Nationwide Distribution in the states of AL; CA; CO; FL; KY; MA; NY; OH; SC; TX; UT; VA and WI.
Instructions for Use (IFU) for Progesterone 3 Calibrator Set, repackaged as one set/package.       The Instructions for Use (IFU) included in the package was for the incorrect lot number. Only the IFU required correction.
41 single sets of Progesterone 3 calibrators
Instructions For Use had incorrect lot number and calibrator values
Catalog Number 02534001 (One set of Calibrators US)    Lot G13C303 (only those received/repackaged in the US)
Worldwide Distribution - US, including the states of WA and MD; and, the country of Japan.
DIAMOND-FLEX CIRCULAR RETRACTOR, ANGLED, 40MM 5MM, Product Code 89-6114, Lot Code(s): 878971; 879366; 879404, and Date Code:  C16.    Designed to retract or elevate organs and tissue to provide better visualization access.
BD, formerly CareFusion, has identified a potential risk associated with a weld failure which could result in the wire protruding thru the tip of the instrument when articulated. If this failure were to occur while in use in a procedure it has the potential to damages tissue or organs
Worldwide distribution.  US nationwide (AL, AR, AZ, CA, CO, CT, FL, GA, IA, IL, IN, KS, KY, LA, MA, MD, MI, MN, MS, NJ, NY, OH, PA, TX, WA, WI, WV),  Sweden, South Africa,  Chile, Australia,  New Zealand,  Canada,  United Kingdom, Switzerland, Colombia,  and Poland.
Stryker Orthopaedics Trident Constrained Liner Inserter/Impactor Tip, 22 mm, 28 mm, and 32 mm.  Non Sterile    Catalog Numbers 2199-2022, 2199-2028 and 2199-2032.    For use in total hip arthroplasty.
Impactors do not meet the required sterility assurance level (SAL) of 10-6 when using the recommended steam sterilization method.
Catalog Nos. 2199-2022, 2199-2028 and 2199-2032  All lots manufactured from May 30, 2012
Cardinal Health Mono Rapid Test, Catalog No. B1077-28,   a simple test that utilizes an extract of bovine erythrocytes to qualitatively and selectively detect IM heterophile antibodies in whole blood, serum or plasma in just minutes.
The Positive Control information referencing human plasma as the antibody material described in the product labeling and packaging is incorrect.
Acceava Mono II Rapid Test Strip (Whole Blood, Serum, Plasma), Catalog No. 92404.  Mononucleosis Rapid Test Device a simple test that utilizes an extract of bovine erythrocytes to qualitatively and selectively detect IM heterophile antibodies in whole blood, serum or plasma.
Henry Schein One Step + Mono Rapid Test Device, Catalog No. 9004070 a simple test that utilizes an extract of bovine erythrocytes to qualitatively and selectively detect IM heterophile antibodies in whole blood, serum or plasma in just minutes.
Signify Mono (Whole Blood, Serum, Plasma), Catalog No. 01P52-25   a simple test that utilizes an extract of bovine erythrocytes to qualitatively and selectively detect IM heterophile antibodies in whole blood, serum or plasma in just minutes.
Stanbio Rely Mono Rapid Test, Catalog No. 6200-010L and 6200-020L   a simple test that utilizes an extract of bovine erythrocytes to qualitatively and selectively detect IM heterophile antibodies in whole blood, serum or plasma in just minutes.
Clearview MONO (Whole Blood, Serum, Plasma), Catalog No. 92401   a simple test that utilizes an extract of bovine erythrocytes to qualitatively and selectively detect IM heterophile antibodies in whole blood, serum or plasma in just minutes.
Proadvantage Mono Rapid Test Cassette, Catalog No. P080016   a simple test that utilizes an extract of bovine erythrocytes to qualitatively and selectively detect IM heterophile antibodies in whole blood, serum or plasma in just minutes.
Divalproex Sodium Delayed-release Tablets USP, RX, 250 mg, 100 count bottles, Manufactured in Israel by: TEVA PHARMACEUTICALS IND. LTD. Jerusalem, 9777402, Israel, Manufactured for: TEVA PHARMACEUTICALS USA, INC. North Wales, PA 19454, NDC 0093-7440-01.
mitoXANTRONE Injection USP (concentrate), 20 mg/10 mL (2 mg/mL), 10 mL Multiple Dose Vial packaged in a carton, Rx only, Teva Parenteral Medicines, Inc., Irvine, CA  92618, NDC 0703-4685-01.
Failed Impurities/Degradation Specifications: High out of specification results for Impurity D.
GFS Sea Salt Caramel Cheesecake, 68 oz, 14 cut with papers.  Manufactured by The Fathers Table and Distributed by Gordon Food Service.
GFS Triple White Chocolate Cheesecake, 68 oz, 14 cut with papers.  Manufactured by The Fathers Table and Distributed by Gordon Food Service.
GFS Brownie Cheesecake, 54 oz, 12 cut with papers.  Manufactured by The Fathers Table and Distributed by Gordon Food Service.
GFS Creamy Indulgence NY Style Cheesecake, 68 oz, 12 cut with papers.  Manufactured by The Fathers Table and Distributed by Gordon Food Service.
GFS Raspberry Lemonade Cheesecake, 68 oz, 14 cut with papers.  Manufactured by The Fathers Table and Distributed by Gordon Food Service.
GFS Fruit Swirl Variety Cheesecake, 68 oz, 12 cut.  Manufactured by The Fathers Table and Distributed by Gordon Food Service.
US Nationwide Distribution including Puerto Rico and the states of  AK,AL,AR,CA,CO,CT,DE,FL,GA,HI,IA,IL,IN,KS,KY,LA,MA,MD,MI,MN,MO,MS,NC,ND,NE,NH,NJ,NM,NV,NY,OH,OK,OR,PA,RI,SC,TN,TS,TX,UT,VA,WA,WI,WV, and WY.
Babytherm 8004/8010, Infant Warmer, Class II device, 510 K K971198, Catalog # FR00105 (Babytherm 8010), 2M30404 (Babytherm 8004), non sterile, software controlled.    Product Usage:  Babytherm 8004/8010 is an open care infant warmer system for warming premature babies, neonates and infants with a body weight of up to 8 kg (17.6 lbs). The device is intended for use in delivery rooms, operating rooms, maternity and obstetric units, neonatal and pediatric wards, neonatal and pediatric intensive care units. Therapy and nursing uses: - As a resuscitation table and in birthing rooms, obstetric units, and NICUs - As infant warmer bassinet during normal and intensive care - For infant re-warming and compensation of heat loss - For thermal stabilizing of infants with mattress heater (Babytherm 8010 only) - For gentle warming therapy using the combination of radiant and mattress heater - Cooling infants with fever (temperature of mattress below infant body temperature, Babytherm 8010 only) - With adjustable bed tilt for treatment of infants in Trendelenburg and reverse Trendelenburg position - For weaning infants from incubators - For O2 and nebulizer therapy (with appropriate accessories) - For lowering an infant s bilirubin levels when using the phototherapy option
Risk associated with operating the device in skin temperature mode with temperature sensors attached but no patient connected.
Serial Numbers: ARLN-xxxx to ASFE-xxxx  Catalog Numbers: FR00105 (Babytherm 8010), 2M30404 (Babytherm 8004)
Distributed to:               CA, CT, DE, FL, GA, IA, IN, KS, KY, LA, MA, MD, MI, MO, NC, NJ, NM, NY, OH, OK, PA, TN, VA, WA
Worldwide Distribution - US (nationwide)  and Internationally to SZ, TR, BE, CH, DE, DK, ES, FI, FR, GB, IS LV, NL, NO, SE, SI, AU, CN, IL, JP, NZ, IN, QA, PE, AE
Molift Air 205, Molift Air 205 Propulsion, Molift Air IRC, Molift Air 205 IRC Propulsion, Molift Air 300, Molift Air 300 Propulsion, Molift Air 300 IRC, Molift Air 300 IRC Propulsion  Molift Air is a ceiling hoist used to lift and transfer immobilized patients in various situations. The coupling that holds the suspension is fixed to the lifting belt by a bolt through an aluminum housing. The bolt is hold in place by a rubber cap secured with a small screw. The other end of the lifting belt is fixed to the lifting drum on the motor. The design is identical on both Air 205 and Air 300 in all variants
Potential for the bolt on the suspension coupling on the Molift Air to come loose from the housing.
Undeclared food allergen FD&C Yellow #6.
12 oz presentation: LOT: 28J, EXP: 12/16  32 oz presentation: LOT: 31R JN, EXP: 09/16
US Distribution to the states of : FL, TN, and TX.
GE Inspection Technologies, LP - Phoenix v|tome|x m240 cabinet x-ray systems.    A microfocus CT system used primarily for 3D metrology and analysis.
Radiation emissions which exceeded the limit in the performance standard were detected during maintenance of one system.  The identified cause was insufficient attachment of shielding in the door.  Jostling during delivery was identified as the probable cause of this failure to comply with the performance standard.
AnastoClip AC 8cm 35 Clips (1 Each} Large  REF # 4000-07     The Anastoclip Clip applier consists of a rotating shaft and an integral cartridge containing titanium clips.  The Anastoclip Universal Clip Remover is intended to remove Anastoclip AC Clips as necessary. It is an accessory to the Anastoclip AC Clip Applier.
US marketing brochure for the AnastoClip AC Closure  System states that the Anastoclip catalog numbers  can be used for dura closure, but the catalog numbers are only intended for cardiovascular use.
AnastoCiip Universal Clip Remover (6 Pack}  REF# e4001-00     The Anastoclip Clip applier consists of a rotating shaft and an integral cartridge containing titanium clips.  The Anastoclip Universal Clip Remover is intended to remove Anastoclip AC Clips as necessary. It is an accessory to the Anastoclip AC Clip Applier.
AnastoCiip Universal Clip Remover (6 Pack}   REF# 4001-00     The Anastoclip Clip applier consists of a rotating shaft and an integral cartridge containing titanium clips.  The Anastoclip Universal Clip Remover is intended to remove Anastoclip AC Clips as necessary. It is an accessory to the Anastoclip AC Clip Applier.
AnastoCiip Universal Clip Remover (1Each}  REF# 4001-04     The Anastoclip Clip applier consists of a rotating shaft and an integral cartridge containing titanium clips.  The Anastoclip Universal Clip Remover is intended to remove Anastoclip AC Clips as necessary. It is an accessory to the Anastoclip AC Clip Applier.
Anastoclip AC 8cm 35 Clips (1 Each} Medium  REF # 4000-06    The Anastoclip Clip applier consists of a rotating shaft and an integral cartridge containing titanium clips.  The Anastoclip Universal Clip Remover is intended to remove Anastoclip AC Clips as necessary. It is an accessory to the Anastoclip AC Clip Applier.
US marketing brochure for the AnastoClip AC Closure  System states that the Anastoclip catalog numbers  can be used for dura closure, but the catalog numbers are only  intended for cardiovascular use
Anasto AC Closure System and Anasto Universal Clip Remover-   Anasto AC 8cm 25 Clips (1 Each}  X-Large   REF # 4000-08    The Anastoclip Clip applier consists of a rotating shaft and an integral cartridge containing titanium clips.  The Anastoclip Universal Clip Remover is intended to remove Anastoclip AC Clips as necessary. It is an accessory to the Anastoclip AC Clip Applier.
AnastoCiip Universal Clip Remover (1Each}  REF# e4001-04    The Anastoclip Clip applier consists of a rotating shaft and an integral cartridge containing titanium clips.  The Anastoclip Universal Clip Remover is intended to remove Anastoclip AC Clips as necessary. It is an accessory to the Anastoclip AC Clip Applier.
Worldwide Distribution - US Nationwide (including Puerto Rico) and the countries of: Australia, Canada, Colombia, Germany, Guatemala, Netherlands, Singapore, Tunisia, , Spain
Allegra X-5 rotor yoke, Catalog No. (Instruments) B30589 and B30590 (Rotor) B30593. Product Labeling: IFU B29071AA.    Product Usage:  For In Vitro Diagnostic Use. The Allegra X-5 is intended for the separation of components through the use of relative centrifugal force. It is designed to separate human samples, including blood and other body fluids, for processing, analysis and in vitro diagnostic testing, as well as non-human body samples and chemicals, including industrial and environmental samples. This centrifuge should be operated by qualified personnel only.
A defective rotor yoke on Allegra X-5 allows improper rotor seating on the hub resulting in possible rotor failure if the buckets are loaded in an imbalanced configuration.
Worldwide Distribution -- United Arab Emirates, Angola, Australia, Belgium, Bulgaria, Canada, Switzerland, China, Colombia, Costa Rica , Czech Republic, Germany, Denmark, Egypt, Eritrea, Spain, Finland, France, United Kingdom, Greece, Guatemala, Hong Kong, Indonesia, Ireland, India, Italy, Jordan, Japan, Korea, Republic of, Kuwait, Lebanon, Lithuania, Morocco, Mexico, Malaysia, Namibia, Netherlands, Norway, New Zealand, Oman, Panama, Philippines, Pakistan, Poland, Portugal, Paraguay, Qatar, Romania, Serbia, Russian Federation, Rwanda, Saudi Arabia, Sweden, Singapore, Slovakia, Swaziland, Thailand, Tunisia, Turkey, Taiwan, US (including Puerto Rico), Vietnam, South Africa, and Zimbabwe.
UniCel DxC Synchron Clinical Systems and UniCel DxC Synchron Access Integrated Clinical Systems    The affected part is Part number 70300. Part number 970300 is used to transfer No Foam Solution from the No Foam Bottle to the Waste B canister and the Waste Manifold on the DxC Hydro System.     Catalog No.  UniCel DxC 800 Synchron Clinical Systems  UniCel DxC 600 Synchron Clinical Systems  UniCel DxC 600i Synchron Access Integrated Clinical Systems  UniCel DxC 880i Synchron Access Integrated Clinical Systems  UniCel DxC 660i Synchron Access Integrated Clinical Systems    Product Labeling Reference No. A93719    For the in vitro determination of a variety of general chemistries, therapeutic drugs, and other chemistries.
Possible leaking of No Foam solution from the No Foam Bottle Assembly on the UniCel DxC Synchron Systems.
Distributed in the US to the states of FL, VA, OK, CO, DC, and IN.
Integra External Fixation System Rocker Bottom Model # 12225400.    For use in the treatment of bone conditions amenable to treatment by the use of external fixation.
The silicone insert embedded in the rocker bottom has the potential to become dislodged or loose from the rocker bottom mold.
US and Mexico, Japan,  Chile, Kuwait, Columbia, Hong Kong,   China, Uruguay, South Africa, Costa Rica, South Korea, Singapore, New Zealand, El Salvador, Bahrain, Uruguay, Lebanon, United Arab Emirates, Brazil, Argentina, Netherlands Antilles,  British Virgin Islands,
Quickie Q7 wheelchair. Model EIR4    Physical Medicine.  The Quickie Q7 series of wheelchair's intended use is to provide mobility to persons limited to a sitting position.
12,142 devices in US, 1,710 devices internationally.
There is an observed failure of the backrest bracket which can fatigue over the life time of the product. When this occurs there is the possibility of the bracket fracturing  causing the backrest to detach from the chair frame.
Model EIR 4  13,000 + serial numbers. RES would not accept this number. Please see spreadsheet provided in documents.R4-007239 to R4-022394.  Serial number range:
Worldwide Distribution - US (nationwide) and Internationally to AU, CA, GB, IN, ZA, and TR
SPHERICAL HEAD REFLECTION(R) 6.5 MM CANCELLOUS SCREW, REF 71332525, QTY: (1), STERILE R, smith&nephew  Total hip components are indicated for individuals undergoing primary or revision surgery where other treatments or devices have failed in rehabilitating hips damaged as a result of trauma or noninflammatory degenerative joint disease (NIDJD) or any of its composite diagnoses of osteoarthritis, avascular necrosis, traumatic arthritis, slipped capital epiphysis, fused hip, fracture of the pelvis, and diastrophic variant; congenital dysplasia; old, remote osteomyelitis with an extended drainage-free period, nonunion, femoral neck fracture and trochanteric fractures of the proximal femur with head involvement that are unmanageable using other techniques; femoral osteotomy, or Girdlestone resection; fracture-dislocation of the hip; and correction of deformity.
The labels correctly state that the product should be a 25mm screw, but the box contained a longer, 35mm screw.
Best Theratronics cabinet x-ray systems intended for use in the irradiation of blood and blood products (packaged in transfusion bags) to inactivate T-lymphocytes for the prevention of Graft Versus Host Disease.
It was discovered that both the new device and the predicate device failed to comply with performance standard.
All Raycell units with serial #'s 5000 and higher.
Worldwide distribution.  US nationwide, Antigua and Barbuda, Australia, Austria, Bahamas, Bahrain, Canada, Czech Republic, Germany, Hungary, South Africa, Spain, Sweden, Turkey, and United Kingdom
It is possible that a change to an Order Set will not be saved in the current open Care Plan. This can result in a wrong chemo dose in the order.
Apheresis Red Blood Cells, Leukocytes Reduced
Apheresis products, collected from an unsuitable donor due to a donor screening deviation, were distributed.
Avenir Moller Stems are for cementless use only.
Blood products, in which donor suitability was inadequately determined, were distributed.
Blood and Blood Products for Reprocessing
Dextroamphetamine Sulfate Extended-Release Capsules, 10 mg, 90- count bottles, Rx Only Manufactured by: Actavis Elizabeth LLC Elizabeth, NJ 07207 USA; Distributed by: Actavis Pharma, Inc Parsippany, NJ 07054 USA   NDC 45963-304-09
Acetylcyst 10% OPHT SOL, 10%, 15 mL bottle, Rx only, Medicap Pharmacy, 2790 W Cherry Lane, Meridian, ID  83642, NDC 99999-9996-94.
Lack of Assurance of Sterility: Sterile products were not produced in a controlled, sterile environment.