Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
United States (Nationwide) Distribution including Puerto Rico and American Virgin Islands.
LifeCare PCA 3, PCA Serial List Number 12384    Allows for clinician administration or self-administration of analgesic medications.
Screw rotation error occurring when the pump detects a mismatch between the number of steps given to the motor driving delivery and the number of steps the motor actually took. When this malfunction occurs, the pump will alarm and infusion stops.
LifeCare PCA Infusion System with Hospira MedNet Software, PCA Serial List Number 20709    Allows for clinician administration or self-administration of analgesic medications.
Nationwide to CO, UT, ID, NM, and KS. No foreign/VA/gov/military.
Whole Foods Market, CC & FP HSH Coconut Curry Cauliflower Salad, SOLD BY THE POUND, CLEAR PLASTIC CONTAINERS.
Whole Foods Market is recalling CC & FP HSH Coconut Curry Cauliflower Salad because an undeclared allergen, almonds, was mistakenly included in the salad kit.
PLU 27436000000  PLU 27436100000  ALL AFFECTED PRODUCT HAD A USE BY DATE OF 8/1/15
AR, AZ, CA, CO, ID, KS, LA, MO, MS, OK, OR, TN, TX, UT, WA
Campbell's SpaghettiOs Original Pasta in Tomato and Cheese Sauce Net Wt. 14.2 ounces in metal cans, NDC: 0-51000-22432-3
Potential choking hazard posed by pieces of red plastic found in cans.
MA,  MD, NJ,  NY, PA,  TX    Foreign: Beijing
Foreign Object; Cylindrical metal Pit (Passive Integrated Transponder)  tags .
Distributed to customer distribution centers in FL, IA, IL, IN, KY, NC, NY, OK, TX, and VA.
Keebler, Sugar Wafers, Vanilla, Net Wt 2.75 OZ (77 g), Made in Canada Distributed By Kellogg Sales Co, Battle Creek, MI 49016 USA
Sugar wafer cookies contain an ingredient that was recalled by the ingredient manufacturer due to the presence of extraneous foreign matter in the refined granulated sugar (ingredient in the finished product).
Keebler, Sugar Wafers, Strawberry, Net Wt 2.75 OZ (77 g), Made in Canada Distributed By Kellogg Sales Co, Battle Creek, MI 49016 USA
Family Gourmet, Sugar Wafers, Vanilla, Net Wt 8 OZ (227 g), Distributed By: Family Dollar Services, Inc. Charlotte, NC 28201 USA Product of Canada
Family Gourmet, Sugar Wafers, Strawberry, Net Wt 8 OZ (227 g), Distributed By: Family Dollar Services, Inc. Charlotte, NC 28201 USA Product of Canada
Rajbhog Foods No Eggs Butter Cookies 5 oz.  Distributed by Rajbhog Foods (NJ) Inc., Jersey City NJ 07304  UPC 735426355066  item B006
Rajhbog Foods no Eggs Butter Cookies contain undeclared wheat based on NYSDAM Sampling.
US: MN, WI, WY, NY, MA, TN, WA, IL, CO, CA, RI, MI, TX, GA, AZ, NJ, OH.    OUS:  CANADA
Fromm Family, 12 oz. (340 G), Grain Free, Gold Salmon & Chicken Pate, Food For Dogs,  can 12/case code 11891, individual can upc  0 72705 1189 08.
Fromm has discovered through its own analysis that the some varieties canned dog foods do not contain recommended levels of vitamins and minerals. These products may contain elevated levels of Vitamin D.
All Lot numbers and best before dates of the above referenced product codes
Fromm Family, 12 oz (340 G), Grain Free, Gold Chicken & Duck Pate, Food for  Dogs,  can 12/case code 11895, individual can upc 0 72705 11894 6.
Fromm Family, 12 oz.(340 G), Grain Free,  Gold Chicken Pate,  Food For Dogs,  can 12/case code 11893, individual can upc 0 72705 11892 2.
Fresh Food Market Cranberry Chicken Salad, UPC 207063-4XXXX, various package sizes.  Product sold both from bulk service case and self-service case random weight in deli cups. Product is privately labeled and the address is shown as QFC, 10116 NE 8th, Bellevue, WA 98004.
Fresh Food Market Cranberry Chicken Salad is recalled because product may be mislabeled and may contain undeclared pecans, wheat, and soy.
Product was distributed to TX.  There was no foreign/military/government distribution.
MPF Classic Dry Custom Canine Premix, Product No. 4629, packaged in bulk 2000 lb totes.  Manufactured for XF Enterprises, Inc., Hereford, TX 79045.
Product labeled for canine use is contaminated with monensin.
Connecticut, Delaware, Kentucky, Maine, Maryland, Massachusetts, New Hampshire, New Jersey, New York, North Carolina, Ohio, Pennsylvania, Rhode Island, South Carolina, Tennessee, Vermont, Virginia, Washington DC, and West Virginia.
Cobblestone Bread Co. Wheat English Muffins, 12 oz. (6 count)plastic bag (340g)  UPC: 0 72250 01316 1
BEST BY DATES OF OCTOBER 28, 2015 THROUGH APRIL 10, 2016
RX 214-650; Iron  20% ( 200 mg /ml), Pharmacosmos Lot # P926, Vet Rx Lot # V20030716, Beyond Use Date: 03/17 Made by JBE, Volume 1000 ml bag
Vet Rx Pharmacy is recalling RX 215-650, 200 mg/ml Iron 1000 ml bag because product failed the sterility test.
Vet Rx Lot # V20030716, Product Code 4001500
Novus Snack brand Golden Raisins, Net 10 oz., Product of U.S.A. --- Firm on label: Packed for Ryszard food Distributor, Inc.
The product contained undeclared sulfites (1337.2 ppm) based on sampling and analysis by New York State Department of Agriculture and Markets.
Domestic: IL, FL, NY, OH, LA, MO, MA; International: Canada, others will be inserted
IG1, IGF-I reagent, Catalog # LKGF1; For the quantitative measurement of insulin-like growth factor I (IGF-I) in serum or heparinized plasma.
24 minutes of incubation is required prior to processing patient samples and for the pretreatment solution to reach full equilibration when using pretreatment solution when using the pretreatment solution (LGFA) contained in the kit.
Ajinomoto Windsor Inc., Golden Tiger Plant
Toasted Onion Battered Green Beans, Net Wt. 12lb (5.44kg), 6/2 lb. bags., Product # 275720
Ajinomoto Windsor is recalling various Not-Ready-To Eat frozen food items due to the potential for these products to be contaminated with Listeria monocytogenes.
limited to date code 0945280 on the master case
VIP-STEAMWORKS MIX VEGETABLES, 12 pk./12 oz., Product # 7007706576
Battered Corn Nugget, Net Wt. 32oz (2lbs) 907g, 6/2lb bags, 4/3lb bags, Product #241120, 241620.    UPC: 10050650024115
VIP-STEAMWORKS ORGANIC MIXED VEGEGETABLES, 6 pk./24 oz., Product # 7007706476
MOLLYS KITCHEN BATTERED VEGETABLE STICKS, 6/2 lb. bags, Product # 673692
SPICY BREADED CORN NUGGET w/JALAPENO, 6/2 lb. bags, Product # 241720, 864964
BATTERED SWEET CORN NUGGET, 6/2 lb. bags, Product # 241550, 672685
TAI PEI PDQ SHRIMP FRIED RICE, Net Wt. 12 oz (340g), 9/12 oz. pails, Product # 82072
VIP-STEAMWORKS ORGANIC PEAS, 6 pk./24 oz., Product # 7007706464
VIP-STEAMWORKS ORGANIC SWEET CORN, 6 pk./24 oz., Product # 7007706448
TAI PEI SHRIMP FRIED RICE, 8/12 oz. pails, Product # 7007700806
OLD PARK SOUTHWEST VEGETABLE SPRING ROLL, 162 ct./1.5 oz., Product # 56857
WAHOO-BATTERED VEGGIE FRIES, 6/2 lb. bags, Product # 229650
VIP-QP PETITE PEAS, 12/16 oz., Product # 7007701065
TAI PEI GARDEN VEGETABLE RICE, Net Wt. 18oz (510g), 8/18 oz. pails, Product # 82070
VIP-STEAMWORKS SWEET CUT CORN, 12 pk./12 oz., Product # 7007706548
Molly's Kitchen Battered Green Beans, 6/2 lb. bags., Product # 671850
1.  AJINOMOTO VEGETABLE FRIED RICE, Net Wt. 27 lb (9 ct./3 lb. bags.), 12.25 kg, Net Wt. 27lb (12.24kg), 9/3 lb. bags., Product # 5650053, 5650273    2.  MINH brand 4 ct./3 lb. bags;    3.  JADE MOUNTAIN brand, 4 ct./3 lb. bags;    4.  FIRST STREET brand, 16 oz (1lb) 454g, 12/1 lb. bags;    5.  Hy Vee brand, 16oz (1lb) 454g, 12/1 lb. bags.
ALL STOCK TASTY 10%, A TEXTURED SWEET FEED FOR CATTLE AND HORSES, NET WT. 50 LBS (22.68 KG), MANUFACTURED BY TUCKER MILLING, LLC
The firm received a small number of reports of  choking in horses.
Woodstock Farms Mfg. Cranberry Nut Seed Mix Net Wt. 25 Lbs. Packed by by Woodstock Farms Mfg. Edison, NJ 08817   UPC 7523914090
Walnut pieces may be contaminated with Listeria monocytogenes which was determined through Third Party Sampling.
Best by 12/15/16 Lot Code 16074  Best by 01/05/17 Lot  Code 16091
Market Basket Walnuts Raw Net Wt. 7 oz Distributed by Demoulas Supermarkets, Inc. Tewksbury, MA 01876     UPC 049705408094
Best by 04/14/17 Lot  Code 16105  Best by 03/23/17 Lot  Code 16083
Nature's Promise Walnuts Halves &  Pieces Net Wt. 7 oz   Product of USA UPC 688267144042
Best by 4/19/17 Lot Code 16110   Best by 04/02/17  Lot Code 16093
Walnuts Halves & Pieces Net Wt. 2.5 lbs  Distributed by Woodstock Farms Mfg. Edison, NJ 08817 Product of USA
Woodfield Farms Walnuts Halves & Pieces Net Wt. 2.5 lbs  Distributed by Woodstock Farms Mfg. Edison, NJ 08817 UPC 075239001944  Product of USA
Market Basket Cape Cod Cranberry Trail Mix  Net Wt. 10 oz (284 g) Distributed by Demoulas Supermarkets, Inc. Tewksbury, MA 01876 UPC 049705408322
Woodstock Cape Cod Cranberry Mix Net Wt. 10 oz.  Distributed by Woodstock 313 Iron Horse Way Providence RI 02908 USA UPC 042563008772
Woodstock Walnuts Halves & Pieces Net Wt. 6 oz. Distributed by Woodstock 313 Iron Horse Way Providence, RI 02908 USA   UPC 042563008604
Woodstock Farms Mfg. Cape Cod Cranberry Mix Net Wt. 25 Lbs.  Distributed by Woodstock Farms Mfg. Edison, NJ 08817  UPC C250575
Walnut pieces may be contaminated with Listeria monoctyogenes which was determined through Third Party Sampling.
Walnut Combo Halves & Pieces, 25 lbs      Label not available as per firm.
Nature's Promise Cranberry Trail Mix Net Wt. 12 oz Distributed by Foodhold USA LLC Landover, MD 20785  Product of USA UPC 688267066122
distributed in IL, PA, RI, and WA and in Canada
IQF Green Beans, packed in a 10 oz. (US) and a 283 g (Canadian) kraft paper bag with food grade liner, 12 bags to a case. The UPC code 6 38882 00053 7.      The cooking instructions on the label is read:    How To Prepare    Stovetop: Place frozen green beans into a small amount of boiling water. Cover, steam for 3 to 5 minutes or until tender. Drain and season to taste.    Microwave: Place frozen green beans into a covered microwave- safe dish. Add 1/2 cup water and a spoonful of butter (optional) and cook on high for 3 to 5 minutes, stirring occasionally. Drain and season to taste.
Stahlbush IQF Green Beans are recalled due to the potential to be contaminated with Listeria monocytogenes.
. Dollywood sweet and salty trail mix packaged in an 11 oz clear plastic bag with a grey sticker label containing red lettering. UPC 490000503272
Sunflower kernels received from the supplier and subsequently used in the trail mix bag may be contaminated with Listeria Monocytogenes.
U.S. distribution to the following; CA    No foreign distribution.
Gluten levels above regulatory threshold.
HMSHost received a total of 1,275 pounds of product under the lot codes that are recalled which were distributed to 34 customers in total. Distribution is only for US and to HMSHost Airports & Travel Plazas Concepts/Stores. No Foreign Country was affected.
Woodstock Cape Cod Cranberry Mix, 25lbs.  Item #250575    The product  also goes by the following trades names:    1). 1897 Cape Cod Cranberry Mix 7oz  2). Ciao Cape Cod Cranberry Mix 7oz  3). Farmers Market Cape Cod Cranberry Mix 7oz  4). Grounded In Cape Cod Cranberry Mix 7oz  5). La Tapenade Cape Cod Cranberry Mix 7oz  6). Marche Cape Cod Cranberry Mix 7oz  7). MKT Cape Cod Cranberry Mix 7oz  8). Pronto Cape Cod Cranberry Mix 7oz  9). PZA Cape Cod Cranberry Mix 7oz  10). The Local Cape Cod Cranberry Mix 7oz  11). Urban Market Cape Cod Cranberry Mix 7oz  12) Fresh Attraction Cape Cod Cranberry Mix 7oz
Woodstock Farms informed HMSHost of their  recall.   HMSHost purchase bulk snacks from Woodstock Farms , has discovered during their routine testing that the walnuts used in the recalled items/products may have the presence of Listeria  Monocytogenes.  HMSHost repackaged the bulk snack under several private label brands to sell to the consumer.  HMSHost is initiating a precautionary voluntary recall.
AR,GA, IA, KY, MI, MN, NY, OH, PA, TN and  VA.
The firm was notified by their supplier that the products may be contaminated with Listeria monocytogenes.
Blue Buffalo Life Protection Formula Fish & Sweet Potato Recipe for Dogs, 30 lb bag.    UPC Code:	859610000326
Worldwide distribution.  US nationwide, Australia,  Austria, Denmark, France, Germany, Iceland, Ireland, Italy, Netherlands, Norway, Poland, Saudi Arabia, Singapore, Slovenia, Spain, Sweden, Switzerland, United Arab Emirates, and England
Philips Expression Information Portal (IP5) Model 865471.   The IP5 is intended to be used as a secondary display control unit for the Expression MRI Patient Monitoring System and the Expression MR200 MRI Patient Monitoring System.
Frozen Display Numerics and Disabled Menu Keys after extended run time.  This customer notification was sent August 22, 2014.
Eillien's Candies was notified by Sunopta, an ingredient supplier that the sunflower kernels may be contaminated with Listeria monocytogenes.  In turn Eillien's in recalling a number of products manufactured with Roasted Salted Sunflower Kernels and / or Roasted Unsalted Sunflower Kernels.  There have been no reported illnesses to date.
FIGI'S HOT & SPICY CAJUN SNACK MIX, 16 OZ (453 G),   UPC 609883  Item # 609883.
BLAIN'S FARM & FLEET, The BIG  GAME PARTY TRAY B 25 OZ, UPC 034952822434, Item # 612547.  7/15/16, 6/17/16.
HOLIDAY PANTRY, RAISIN & NUT , NET WT. 9 OZ(255 G),   UPC:  041282995424, Item # 130476.
Eillien's Cranberry Sesame Sunflower Kernel Mix, Net WT 14 oz (397 g), UPC 034952586572, Item # 698274.  10/22/16.    Item #512236, WIP EIL CRAN SESAME KERN MX25#, 512236.  6/21/16, 8/11/16
BULK - ROASTED  & SALTED SUNFLOWER KERNELS 50#,   UPC: 034952142440. No CODE.    EILLIEN'S ROASTED & SALTED SUNFLOWER KERN 7 OZ (198 g) ,   UPC 034952575576 Item 800139.    PIGGLY WIGGLY ROASTED &SALTED  SUNFLOWER KERNELS   13 OZ(369 g), UPC 034952574159 Item # 669788..    Royal Snacks, Roasted & Salted Sunflower Kernels, Net WT 11 oz (312 g), UPC: 034952571356.    PIGGLY WIGGLY, Roasted & Salted  SUNFLOWER KERNEL , 14 OZ(397 g).   UPC: 034952580945, Item # 691378.    PIGGLY WIGGLY , Roasted & Salted SUNFLOWER KERNELS,  4 OZ(113 g), UPC: 034952579864, Item # 623645..
Mae's Corner Market, Sedona Mix,  14 OZ (397 g),   UPC 034952415230, Item # 610587.
Mae's Corner Market, FIJI MIX,  14 OZ(397 g) ,   UPC 034952415247, Item # 610611.
Mae's  Corner Market,  HOLIDAY PARTY TRAY MIX  31.4.5OZ( 1 lb 15.5 oz) 838 g, UPC 034952410549, Item # 681080.
nationwide.  OUS to include:  Bahamas, Bermuda, Cambodia, Costa Rica, Dominican Republic, El Salvador, Honduras, Jamaica, Netherlands Antilles, Panama, Singapore, Trinidad and Tobago, Vietnam
Post Great Grains Protein Blend, Honey, oats & seeds cereal.  Net Wt. 13.5 oz (382 g) carton with plastic liner.  UPC 84912-00456.  Post Foods LLC, 1 Upper Pond Road, Parsippany, NJ  07054
Post Great Grains Protein Blend - honey oats & seeds cereal is being recalled because it contains sunflower seeds that have the potential to be contaminated with Listeria monocytogenes.
Essential Foods Inc. dba Globespun Gourmet
Globespun Gourmet Tandoori- flavors of India, net wt. 8 oz., plastic wrapped. UPC 32328 00211.
Globespun Gourmet Tandoori 8 oz wrap is recalled because an ingredient (peas) has the potential to be contaminated with Listeria monocytogenes.
Globespun Gourmet Dolma La- Tibetan potato, net wt. 8 oz., plastic wrapped.  UPC 32328 00503.
Globespun Gourmet Dolma La 8 oz wrap is recalled because an ingredient (peas) has the potential to be contaminated with Listeria monocytogenes.
Globespun Gourmet Coconut Curry, net wt. 8 oz, plastic wrapped.  UPC 32328 00210
Globespun Gourmet Coconut Curry 8 oz wrap is recalled because an ingredient (peas) has the potential to be contaminated with Listeria monocytogenes.
Globespun Gourmet Thai, net wt. 8 oz, plastic wrapped.  UPC 32328 00405.
Globespun Gourmet Thai 8 oz wrap is recalled because an ingredient (peas) has the potential to be contaminated with Listeria monocytogenes.
U.S. distribution to the following; CA.    No foreign distribution.
Jugo Moringa Plus Antiox  32 oz    Distributed By:   GMJ Natural Products  Anaheim, CA 92801    UPC Code: 14465 77631
Undeclared whey protein which contains the allergens of milk and soy lecithin.
Product was distributed in Missouri and Minnesota.  No government or military distribution.
EAT Barbeque Zero to Hero, a Sweet Rub, packaged in 6.5oz bottles (mislabeled).  The responsible firm named on the label is Pellet Envy, LLC in Kansas City, USA.  UPC code is 859849005024.  The correct label should read 6.7oz.  Bottles are packed in cases of 6.
Some bottles of barbeque seasoning without a statement noting the product contains MSG (monosodium glutamate).
Sweet Pea Pasta Salad  10 lb cardboard case (2, 5lb plastic bags), 2 lb rigid plastic container, 14 oz. rigid plastic container  Keep Refrigerated
Product has potential of being contaminated with Listeria monocytogenes.
Nationwide, worldwide.  No military/govt/VA consignees.
Colostrum6 Powder (6.5 oz) Item No. 9902;  Sold under the following brands: Immune Tree, Surthrival, HealthWorks (Not purchased since 3/18/15). Packaged in HDPE White bottle, except Surthrival which uses a Brown HDPE Bottle
Immune Tree is recalling certain Immune Tree; Health Works; Immune Pro6; Good For You and Surthrival brand colostrum products due to undeclared milk allergen.
LeptiTrim6 Vanilla Shake Item No. 9907; 860 g. Brand Immune Tree; Packaged using HDPE White bottle
Colostrum6 Capsules 500mg, Item No 9901, 180 ct.  Sold under the brands: Immune Tree, Immune Pro-6 (Not purchased since 8/25/2014), Surthrival, Good For You Canada. Packaged using HDPE White bottle, except Surthrival which uses a Brown HDPE Bottle
Colostrum6 Powder Kilo (35.3 oz); Item No. 9903; Brand Name Immune Tree, Surthrival, Packaged using HDPE White bottle, except Surthrival which uses a Brown HDPE Bottle
Colostrum6 Powder (2.5 oz), Item No. 9915, Sold under brand Immune Tree (discontinued), Packaged using HDPE White bottle
CO, FL, GA,  IL, KY, LA, MI, MN, NJ, NY, NC, OH, OR, PA, SC, TX, VA, WV.
Figi's Gifts in Good Taste, 16 OZ  (453.60 g) Nature's Mix in a plastic bag that is a red circular tin container.     Nature's Mix is packaged in a plastic bulk bag with approximately 8-12 ounces o product.
Figi's Companies, Inc is recalling 2 products that are related to the SunOpta sunflower kernel recall, because they have the potential to be contaminated with Listeria monocytogenes.
Snack Shoppe, 16 OZ Hot & Spicy Cajun Snack Mix in a foil bag that is contained in a tin box. The foil bags are marked with the lot number.
CA, CO, CT, DE, FL, GA, IO, IL, IN, ME, MI, MN, MS, NC, NH, NJ, NY, PA, TN, TX, VA, WA, and WI.
Huberts Lemonade Strawberry, 16 Fl. Oz. (473 ml), Manufactured for: Hamsen Beverage, Tustin, CA 92780.
53, 823 cases (12/16oz. glass bottles per case)
The product may contain foreign material (glass) in some bottles.
Huberts Lemonade Blackberry, 16 Fl. Oz. (473 ml), Manufactured for: Hamsen Beverage, Tustin, CA 92780.
Huberts Original Lemonade, 16 Fl. Oz. (473 ml), Manufactured for: Hamsen Beverage, Tustin, CA 92780.
Huberts Lemonade Watermelon, 16 Fl. Oz. (473 ml), Manufactured for: Hamsen Beverage, Tustin, CA 92780.
Broselow/Hinkle, PEDIATRIC EMERGENCY SYSTEM, PINK/RED Oxygen Delivery Module 2/PACK, Product Code 7700RAW2
The Oral Airway pouch within the PINK/RED Oxygen Delivery Module, 7700RAW, was incorrectly packaged with the 8 cm Berman Oral Airway. The pouch contained within the module is correctly labeled as 5 cm but actually contains an 8 cm Berman Oral Airway component. Therefore, the component within the pouch is incorrect.    The PINK/RED Oxygen Delivery Module, 7700RAW, is intended to be used within the PINK/RED Pouch of the BROSELOW pediatric safety system.    Three (3) lots (lot# 914873, lot# 914876 and lot #914878) of the PINK/RED Oxygen Delivery Module, 7700RAW, are affected by this voluntary Field Safety Corrective Action.
Lot numbers 914873, 914876, and 914878 of the individual modules (7700RAW), which are contained in Lot number 914867 of the 2/PACK (7700RAW2). Expiration Date JAN 2021.
Broselow/Hinkle, PEDIATRIC EMERGENCY SYSTEM, Broselow Complete Set of Colored Pouches, Product Code 7730MOD
Lot numbers 914873, 914876, and 914878 of the individual modules (7700RAW), which are contained in Lot number 916714 of the Broselow Complete Set of Colored Pouches, Product Code 7730MOD. Expiration Date MAR 2018.
Marie Callender's Cheese Biscuit, Restaurant Style;  Packaged in 7 oz. and 14 oz. Stand-up pouches.  UPC - 7 oz. 075968-14015-0, Item number 14015D;  UPC 14 oz. 075968-170110-9, Item number 17011
7 oz. - 4569 cases (12 x 7 oz. per case); 14 oz. - 90 cases (12 x 14 oz. per case)
Firm was notified by supplier that flour used as an ingredient in the cheese biscuit mix has been recalled because it may be contaminated with E-Coli.
7 oz., Item number 14015D;  Lot Codes 6-082-01  - Best by  5/17/17 and lot 6-082-01, Best by 3/22/17;  14 oz. item number 17011; lot code 6-169-05; Best Buy Date of 6/17/17.
Carvediol Tablets, USP, 25 mg, 100-count bottle (NDC 57664-247-88), 500-count bottle (NDC 57664-247-13), 1000-count bottle (NDC 57664-247-18), Rx Only Manufactured by: ALKALOIDA Chemical Company Zrt 440 Tisavasvari Kabay Janos u.  29 Hungary,  Distributed by: Sun Pharmaceutical Industries, Inc. Cranbury, NJ 08512
Carvediol Tablets, USP, 12.5  mg, 500-count bottle (NDC 57664-245-13), 1000-count bottle (NDC 57664-245-18), Rx Only Manufactured by: ALKALOIDA Chemical Company Zrt 440 Tisavasvari Kabay Janos u.  29 Hungary, Distributed by Sun Pharmaceutical Industries, Inc. Cranbury, NJ 08512
Carvediol Tablets , USP, 3.125 mg, 100-count bottle (NDC 57664-242-88). 500-count bottle (NDC 57664-242-13), 1000-count bottle (NDC 57664-242-18), Rx Only Manufactured by: ALKALOIDA Chemical Company Zrt 440 Tisavasvari Kabay Janos u.  29 Hungary, Distributed by Sun Pharmaceutical Industries, Inc. Cranbury, NJ 08512
Carvediol Tablets, USP, 6.25 mg, 100-count bottle (NDC 57664-244-18), 500-count bottle (NDC 57664-244-13), 1000-count bottle (NDC 57664-244-18), Rx Only,  Manufactured by: ALKALOIDA Chemical Company Zrt 440 Tisavasvari Kabay Janos u.  29 Hungary, Distributed by Sun Pharmaceutical Industries, Inc. Cranbury, NJ 08512
Nationwide -    US: Distributors IL, TX, OR, GA, OH.    US: Retail CA, DE, IL, KS, LA, MN, MT, ND, OH, TX, VT, WA.
Poppers brand Mozzarella Cheese Sticks Net Wt. 32 oz. (2 lb) 970 g.  Keep Frozen.  Cook Thoroughly.  UPC 46704-88920.  Distributed by:  Heinz
Monogram Appetizers is recalling Poppers Brand Mozzarella Cheese Sticks because they may contain undeclared egg.
Code:  Line 1 / Line 2:    Best By 03/28/2017 / KA5M14 A HH:MM  Best By 05/28/2017 / KA6B18 A HH:MM  Best By 09/28/2017 / KA6F08 A HH:MM
Honey Peanuts Net Wt. 25 lbs (11.360g) Ing:peanuts, seasoning***honey, wheat starch***Allergen Statement: Contains peanuts and wheat. Manufactured on equipment that processes and packages peanuts and other tree nuts.May contain trace amounts of other nuts. UPC 0 74249 29186 4 Mfg. By: Trophy Nut Co. Tipp City, OH 48371
The firm was notified by their customer that the product contained undeclared pecans.
Product was distributed to 14 U.S. firms. The firm did not distribute to any foreign countries.
12 oz flexible plastic bag containing 12 individually wrapped mozzarella cheese sticks, 24 oz flexible plastic bag containing 24 individually wrapped mozzarella cheese sticks. The product is packaged in a Blue and clear bag with white and black lettering. UPC number: 00 710400 65560 0
A thin layer of the packaging film may remain on the cheese after the consumer opens it potentially causing choking.
10 oz flexible plastic bag containing 12 individually wrapped mozzarella cheese sticks. The product is packaged in a Blue and clear bag with white and black lettering. UPC number: 0 71040 00060 2
Distributed nationwide to Sam's Club only.
Panera Bread Balsamic Vinaigrette Dressing, NET 20 FL OZ (1.25 PT) 591 mL, most responsible firm on the label is Panera Bread St. Louis, MO 63127 PaneraAtHome.com.  Product packaged in plastic bottles and shrink wrapped as a twin pack (2 bottles together).  UPC code is 018959753168 for the single bottle.  The UPC code for the twin pack is 018959753175.
Lot numbers: 10/4/16, 10/6/16, 10/7/16, 10/8/16, 10/15/16, and 10/22/16.  These are expiration dates which are also the lot numbers.
Product was distributed in the following states CA, GA, IL, MI, PA, UT
Oreo Cookies 'n Cream Chocolate Sheet Cake Ice Cream Cake-8981-Baskin Robbins.Cakes are sealed in plastic and packed in a labeled cardboard box. Sheet cake is packed 3 per case. Product is frozen.
Undeclared walnuts in bakery cakes utilized in ice cream cakes
Vanilla Ice Cream Devils Food Rollcake-8941-Baskin Robbins. Cakes are sealed in plastic and packed in a labeled cardboard box.  Roll cake is packed 8 per case. Product is frozen.
Mint Chocolate Chip Devils Food Rollcake -8939-Baskin Robbins.Cakes are sealed in plastic and packed in a labeled cardboard box. Roll cake is packed 8 per case. Product is frozen.  Label has Baskin Robbins
Mint Chocolate Chip Devils Food Sheet Cake-8975-Baskin Robbins.  Cakes are sealed in plastic and packed in a labeled cardboard box. Sheet cake is packed 3 per case. Product is frozen.
Cookies 'n Cream White Sheet Cake-8978-Baskin Robbins.  Cakes are sealed in plastic and packed in a labeled cardboard box. Sheet cake is packed 3 per case. Product is frozen.
Pralines n Cream White Sheet Cake Ice Cream Cake-8979-Baskin Robbins. Cakes are sealed in plastic and packed in a labeled cardboard box. Sheet cake is packed 3 per case. Product is frozen.
Vanilla Devils Food Sheet Cake-8977-Baskin Robbins. Cakes are sealed in plastic and packed in a labeled cardboard box. Sheet cake is packed 3 per case. Product is frozen.
Chocolate Chip Devils Food Sheet Cake- 8976-Baskin Robbins. Cakes are sealed in plastic and packed in a labeled cardboard box. Sheet cake is packed 3 per case. Product is frozen.
Oreo Cookies n Cream Ice Cream Rollcake-8943-Baskin Robbins. Cakes are sealed in plastic and packed in a labeled cardboard box. Roll cake is packed 8 per case. Product is frozen.
Chocolate Chip Devils Food Rollcake-8940-Baskin Robbins. Cakes are sealed in plastic and packed in a labeled cardboard box. Roll cake is packed 8 per case. Product is frozen.
Product was distributed to customers is NE, WI, MO, MN, IL, MT, IN, IA, and KY.
Fish meal, A Protein Source for Livestock Feeds, Stabilized with Ethoxyquin, Net Weight 50 LBS. Consumers Supply, North Sioux City, SD packaged in poly-woven bags
Fish meal is potentially contaminated with Salmonella
Mislabeling of a single batch of FPS 3.5 x 35 mm Locking Screw as being Non-Locking Screws.
Grassfields Gouda Cheese, cut and wrapped in clear plastic
Possible contamination with Shiga toxin-producing E. coli (STEC).
Grassfields Leyden Cheese, cut and wrapped in clear plastic
Grassfields Onion N Garlic Cheese, cut and wrapped in clear plastic
Grassfields Country Dill Cheese, cut and wrapped in clear plastic
Grassfields Fait Gras Cheese, cut and wrapped in clear plastic
Grassfields Polkton Corners Cheese, cut and wrapped in clear plastic
Grassfields Edam Cheese, cut and wrapped in clear plastic
Grassfields Lamont Cheddar Cheese, cut and wrapped in clear plastic
To DC's in AZ. OR, TX,  CA. HI, AZ, WA, AK, NY.
O Organics Vegetable Tray, 18 oz. (1 lb. 2 oz.) 510g plastic tray.  Best If Used By: AUG 11  UPC (incorrect, which is on the tray): 021130984282  Product of USA & Mexico.
Incorrect ingredient label was attached to 18 oz. O Organics vegetable Trays with Creamy Ranch Dressing Dip and therefore do not correctly identify the allergens egg, milk and soy.
Finished product lot serial number 3517681.   Best If Used By: AUG 11.
U.S. distribution to the following; CA, AZ, NV.    No foreign distribution.
El Alteno  Coconut  Shredded Coconut  8 oz.  UPC: 8 20202 00362 9
El Alteno   Raisinettes  Dovales  12 oz.  UPC: 8 20202 00411 4
Nationwide Distribution to AK, AL, AR, AZ, CA, CT, FL, GA, IL, IN, KS, LA, MA, MD, MI, MN, MO, NC, NH, NJ, NV, NY, OH, OK, OR, PA, RI, SC, TX, UT, VA, WA, WI, Hawaii, and Puerto Rico  Argentina, Australia, Bermuda, Brazil, Brunai, Canada, Curacao, Germany, Great Britain, Hong Kong, Ireland, Jordan, Malaysia, New Zeland, Peru, Saudi Arabia, Serbia, Singapore, South Africa, SriLanka, Tunisia, Turkey, United Arab Emirates, and United Kingdom.
RENASYS Sterile Transparent Film and all the RENASYS Dressing kits that contains the RENASYS Sterile Transparent Film  Is intended for patients who would benefit from a suction device (negative pressure) to help promote wound healing by removing fluids including irrigation and body fluids, wound exudates and infectious materials. Examples of appropriate wounds types include chronic, acute, traumatic, Sub-Acute and dehisced wounds, ulcers, (such as pressure and diabetic), partial thickness burns, flaps and grafts.
Sterility seal integrity failures on the Renasys Sterile Transparent Film
US Distributions to the states of : CA and FL., and Worldwide to : Colombia, France, Germany, Italy, and Spain.
3I OSSEOTITE CERTAIN DENTAL IMPLANTS, 4x11.5 mm, Sterile, Rx only.
Nationwide Distribution to AZ, CA, CO, DE, FL, GA, KY, MI, MN, MO, KY, RI, NY, OH, OR, RI, TN, TX, VA, WA    Foreign: None    VA/DOD: None
3.5mm Bowed Locking Compression Femur Plates, 18 hole  Orthopediatrics PediLoc Locking Plate System comes in sets that offer the advantage of both conventional and locking plate fixation devices and instrumentation in one system. Utilizing both locking and non- locking screws, PediLoc offers a construct that resists angular collapse while simultaneously acting as an effective aid to fracture reduction.
OrthoPediatrics Corp.is voluntarily recalling multiple lots of the 3.5mm Bowed Locking Compression Femur 14-hole Plate and 18-hole Plate due to the devices being mislabeled.
3.5mm Bowed Locking Compression Femur Plates, 14 hole  Orthopediatrics PediLoc Locking Plate System comes in sets that offer the advantage of both conventional and locking plate fixation devices and instrumentation in one system. Utilizing both locking and non- locking screws, PediLoc offers a construct that resists angular collapse while simultaneously acting as an effective aid to fracture reduction.
Product Number: 00-1050-3214  Lot Number: NM02341  Product Number: 00-1050-3214  Lot Number: NM02342
Escitalopram Tablets USP 20 mg, 100-count bottles, Rx Only, Manufactured for: Lupin Pharmaceuticals, Baltimore, MD, 21202, Manufactured by: Lupin Limited, Goa 403 722, India, NDC 68180-136-01
Labeling: Incorrect or Missing Lot and/or Expiration Date
All product distributed domestically in the US. No recalled product was distributed to U.S. Government Agency consignees directly by Lupin.  No recalled product was distributed to any foreign consignees by Lupin.
Lisinopril Tablets USP, 40 mg, 1000-count bottles, Rx only, Manufactured for: Lupin Pharmaceuticals, Inc., Baltimore, MD  21202, United States; Manufactured by: Lupin Limited, Pithampur (M.P.) 454 775, INDIA, NDC 68180-517-03.
CGMP Deviations: finished products manufactured using active pharmaceutical ingredients whose intermediates failed specifications.
Lisinopril Tablets USP, 30 mg, packaged in a) 500-count bottles (NDC 68180-516-02) and b) 100-count bottles (NDC 68180-516-01); Rx only, Manufactured for: Lupin Pharmaceuticals, Inc., Baltimore, MD  21202, United States; Manufactured by: Lupin Limited, Pithampur (M.P.) 454 775, INDIA.
The multi-sample needle retractable sheath may not fully retract over the needle during the changes of the blood collection tubes.
Model Number: MED 5223, Lot Number: 201505 l0
Pentax Video Bronchoscope   Designed to be used with a Pentax Video Processor (including light source), documentation equipment, video monitor, endo-therapy accessories (such as biopsy forceps) and other ancillary equipment for endoscopy and endoscopic surgery within the airways and tracheobronchial tree.
Pentax America Inc. is recalling various bronchoscopes which contain an incorrect Operation and Reprocessing IFUS.
Mucinex Sinus-Max Day Night, 60 caplets, Dist. by Reckitt Benckiser, Parsippany, NJ 07054-0224 UPC 363824951737 NDC 63824-207-60
Labeling: Label Error on Declared Strength; label on outer carton incorrectly states Diphenhydramine 25 mg instead of 12.5 mg. Also, quantity is incorrectly stated as 30 daytime and 30 nighttime instead of 36 daytime and 24 nighttime.
Genzyme Corporation / Genzyme Biosurgery
Mozobil (plerixafor injection) 24 mg/1.2 mL (20 mg/mL) per vial, Rx Only, For Subcutaneous Injection only, Manufactured by:  Genzyme Corporation, 500 Kendall Street, Cambridge, MA 02142 A Sanofi Company Country of Origin : United Kingdom, NDC 0024-5862-01
Labeling: Incorrect or Missing Lot and/or Exp. Date
McCormick &  Company - Corporate Headquarters
Product shipped to the following states: AL, AR, AZ, CA, DE, FL, GA, IA, IL, IN, KY, LA, MD, MS, NC, OR, PA, SC, TN, TX, VA, WA, and WI  .     Other Countries: Curacao
ZATARAINS SOUTHERN STROGANOFF PASTA DINNER 6.5 OZ. PACKAGE
The Zatarains plant in Gretna, LA was contacted by General Mills to inform the plant that they were impacted by General Mills flour recall.  Fifty (50) bags of 	WONDRA ENR 50 UNMALTED were shipped to Gretna in March 2016. This material has been used in the production of four different Zatarains brand pasta 	dinner mixes over several processing dates.
McCormick   Material Code  900723030    BEST BY SEPT 20 17Z  BEST BY SEPT 21 17Z   BEST BY OCT 31 17Z  BEST BY DEC 23 17Z  BEST BY DEC 27 17Z
ZATARAINS GUMBO PASTA DINNER 5.7 OZ PACKAGE
McCormick   Material Code  900723033    BEST BY MAR18 18Z  BEST BY APR 26 18  BEST BY JUN 20 18Z
ZATARAINS SCAMPI PASTA DINNER 5.2 OZ PACKAGE
McCormick   Material Code  900723034    BEST BY SEP 19 17Z
ZATARAINS WHITE CHEDDAR CHIPOTLE PASTA DINNER   6 OZ PACKAGE
McCormick   Material Code  900851309    BEST BY OCT 31 17Z  BEST BY NOV 1 17Z  BEST BY DEC 23 17Z
The Perfect Bite Co Hawaiian Style Rice & Vegetable Blend, 4 - 12 OZ Bags, Net Weight 3 LBS., Distributed by: TPBC, Glendale, CA 91203; Best By: 05/20/18.
Firm was notified by North Carolina Dept. of Agriculture that a sample of Better Valu Cut Corn was found positive for Listeria monocytogenes. Firm initiated a recall based on the sample results.
Better Value Mix Vegetables, Federated Group, Inc./Arlington Heights, IL 60005-1096; 14 oz. pkgs; BB 05/06/18;   Morning Fresh Farms Mix Vegetables; Merchants Distributors Inc. of Hickory, NC 28601; 32 oz. pkgs; BB  06/01/18;   Morning Fresh Farms Mix Vegetables, Merchants Distributors Inc. of Hickory, NC 28601; 16 oz. pkgs; BB 5/06/18;   Key Foods Mixed Vegetables, Key Foods Stores/ Staten Island, NY 10314; 16 oz. pkgs; BB 04/22/2018;   Laura Lynn Mixed 5 Way Vegetables, Ingle's Markets Inc./Asheville, NC 28816; 16 oz. pkgs; BB 06/17/18;   Key Foods Steamed Mix Vegetable, Key Foods Stores/ Staten Island, NY 10314; 12 oz. pkgs; BB 04/13/18;
007980124564  12/14 Better Value Mix Vegetables;   007145220333  12/32 Morning Fresh Farms Mix Vegetables;   007145220332  12/16 Morning Fresh Farms Mix Vegetables;   007329607086  12/16 Key Foods Mixed Vegetables;   007329630483  12/12 Key Foods Steamed Mixed Vegetable;   007329607203  12/16 Key Foods Mix Vegetables;   008685401746  12/16 Laura Lynn Mixed Vegetables 5 Way ;     With Best By date ranges: 04/12/18 thru 06/17/18.
Giant Eagle Sweet & Savory Island Quinoa, Giant Eagle, Pittsburgh, PA; 12 oz. pkgs; BB 06/10/18
Laura Lynn Vegetable Gumbo Mix; Ingle's Markets Inc./Asheville, NC 28816, 16 oz. pkgs, BB 05/06/18
Key Foods Soup Mix Vegetables, Key Foods Stores/ Staten Island, NY 10314; 16 oz. pkgs; BB 05/02/18;   Laura Lynn Vegetable Soup Mix, Ingle's Markets Inc./Asheville, NC 28816; 16 oz. pkgs.; BB 04/12/18
Key Foods: Best By: 05/02/18  Laura Lynn: Best By: 4/12/18
Best Valu Cut/Cortado; Yellow Corn; Maiz Amarillo;  Net Wt 14 OZ;  Code: SSFF/R 10308; Best By: 04/11/18;  Product of Canada; Distributed by Federated Group Inc., Arlington Heights, IL  ;   Laura Lynn Cut Corn;  Net Wt 16 oz.; Cut Corn Fresh Frozen For Freshness  Best By: 04/11/18, 05/09/18, 06/06/18; Product of Canada; Distributed by Ingle's Markets Inc., Asheville, NC 28816;     Laura Lynn Family Economy Cut Corn; New Wt 32 OZ.;  Best By: 05/10/18; Product of Canada; Distributed by Ingle's Markets Inc., Asheville, NC 28816;     Key Food Premium Fresh Frozen Vegetables Cut Corn; Keep Frozen; Net Wt 16 OZ.; Best By: 04/11/18, 05/02/18, Product of Canada; Distributed by Key Food Stores, Staten Island, NY 10314;
7980124561	  Better Value Cut Corn;   8685401734	 Laura Lynn Cut Corn;   7329607091	  Key Foods Cut Corn;   732960169895	  Key Foods Cut Corn;   8685401717	 Laura Lynn Cut Corn    Best By date range: 04/11/18 thru 06/06/18.
Sertera Biopsy Device, Sterile; Used primarily in ultrasound-guided breast biopsies.
Incorrect label on the Sertera Biopsy Kit
Blood Centers of the Pacific - Irwin Center
Blood product, for which the residual white blood cell count testing was not performed, was distributed.
Blood products, in which quality control for residual WBC count did not meet specifications, were distributed.
Integra LifeSciences Corp. d.b.a. Integra Pain Management
PHS Spinal Tray 24G Gertie Marx, Catalogue No. 899379.    Intended to provide licensed medical professionals with a kit containing drugs and other medical devices that are used to support the administration of general, local anesthetics.
Integra LifeSciences has recently identified that one lot of Spinal Tray 24 G Gertie Marx Catalogue # 899379 was shipped containing the 24 G Gertie Marx needle without an introducer.
Ephedrine Sulfate Injection, USP, 50 mg/mL, 1 mL Fill in a 2mL Vial (NDC 66758-008-01), packaged in 25 x 2 mL Vials per carton (NDC 66758-008-02), Rx only, Manufactured for: Sandoz Inc., Princeton, NJ  08540.
Lack of Assurance of Sterility: a recent FDA inspection at the manufacturing firm raised concerns that product sterility may be compromised.
Phenylephrine HCI Injection, USP, 10mg/mL, packaged in a) 5 mL Vial, 50 mg/5 mL (NDC 66758-016-03), 25 x 5 mL Vials per carton (NDC 66758-016-04) and b) 10 mL Vials, 100 mg/10 mL (NDC 66758-017-01), Rx only, Manufactured for: Sandoz Inc., Princeton, NJ  08540.
Merge Cardio software.      Product Usage:  Merge Cardio is an integrated cardiovascular information system classified as a picture archiving and communications system.
42 sites potentially have the affected version
Patient information in the header is only found on the first page of the report and not on the subsequent pages.
Worldwide Distribution - US Nationwide in the states of AZ, CA, CO, FL, HI, KS, MA, NC, TX, UT and the countries of: Great Brittan, Peru, Russia, India, Hungary, Thailand, Germany, Azerbaijan, Austria, Italy, Slovakia, Bahrain, and Malaysia.
Sorin/LivaNova is initiating a field correction on the S5 Heart-lung machine because of the potential for failure of the Uninterruptible Power Supply.
Philips Electronics North  America Corporation
Worldwide distribution.  US Nationwide, Canada, AUSTRALIA, FRANCE, GERMANY, INDIA, JAPAN, NETHERLANDS, SOUTH AFRICA, SPAIN, SWEDEN, THAILAND, and UNITED KINGDOM.
HeartStart MRx Monitor/Defibrillator  Models: M3535A and M3536A
The handle can separate from the MRx housing due to breakage of mounts on the rear case.
Three international consignees - Germany, New Zealand and Taiwan
EkoSonic Endovascular Devices    EKOS Intelligent Drug Delivery Catheter
The recalling firm identified ten devices which were distributed and could potentially be non-compliant.  These devices potentially underwent a routine manufacturing test with non-compliant parameters, which may result in a small blister in the epoxy over transducers in the treatment zone.  It is not known at the time the recall was initiated whether the non-compliant test parameters, or presence of the blisters, adversely affect operation of the device.
Worldwide Distribution - US nationwide, PR, and Internationally to Canada, Latin America, Europe, Africa, Middle East, and Asia Pacific.
AMO TECNIS CL Foldable Silicone IOL with OptiEdge Design, Model No. Z9002  The product is indicated for implantation for the visual correction of aphakia in adult patients in whom a cataractous lens has been removed by extracapsular cataract extraction. The lens is intended to be placed in the capsular bag.
Abbott Medical Optics is recalling Intraocular Lenses (IOLs) because they were not being checked prior to release and this may result in the release of mislabeled IOLs.
TECNIS Multifocal Foldable Acrylic Intraocular Lens, Model No. ZMA00  The product is indicated for primary implantation for the visual correction of aphakia in adult patients with and without presbyopia in whom a cataractous lens has been removed by extracapsular cataract extraction and who desire near, intermediate, and distance vision with increased spectacle independence. The lens is intended to be placed in the capsular bag
TECNIS OptiBlue 1-Piece Intraocular Lens (IOL), Model No. ZCB00V  The product is indicated for implantation for the visual correction of aphakia in adult patients in whom a cataractous lens has been removed by extracapsular cataract extraction. The lens is intended to be placed in the capsular bag.
SENSAR 1-Piece IOL, Model No. AAB00  The product is indicated for implantation for the visual correction of aphakia in adult patients in whom a cataractous lens has been removed by extracapsular cataract extraction. The lens is intended to be placed in the capsular bag.
TECNIS 1-Piece IOL, Model No. ZCB00  The product is indicated for implantation for the visual correction of aphakia in adult patients in whom a cataractous lens has been removed by extracapsular cataract extraction. The lens is intended to be placed in the capsular bag
SENSAR Foldable IOL with OptiEdge Design, Model No. AR40e  The product is indicated for implantation for the visual correction of aphakia in adult patients in whom a cataractous lens has been removed by extracapsular cataract extraction. The lens is intended to be placed in the capsular bag.
TECNIS OptiBlue 1-Piece IOL with the TECNIS iTec Preloaded Delivery  System, Model No. PCB00V  The product is indicated for implantation for the visual correction of aphakia in adult patients in whom a cataractous lens has been removed by extracapsular cataract extraction. The lens is intended to be placed in the capsular bag
TECNIS Symfony Extended Range of Vision IOL, Model No. ZXR00  The product is indicated primary implantation for the visual correction of aphakia in adult patients with and without presbyopia in whom a cataractous lens has been removed by extracapsular cataract extraction, and aphakia following refractive lensectomy in presbyopic adults, who desire useful vision over a continuous range of distances including far, intermediate and near, and increased spectacle independence. The lens is intended to be placed in the capsular bag.
TECNIS Multifocal 1-Piece Intraocular Lens, Model No. ZKB00, ZLB00;   The product is indicated for primary implantation for the visual correction of aphakia in adult patients with and without presbyopia in whom a cataractous lens has been removed by extracapsular cataract extraction and who desire near, intermediate, and distance vision with increased spectacle independence. The lens is intended to be placed in the capsular bag
TECNIS 1-Piece IOL with the TECNIS iTec Preloaded Delivery System, Model No. PCB00  The product is indicated for implantation for the visual correction of aphakia in adult patients in whom a cataractous lens has been removed by extracapsular cataract extraction. The lens is intended to be placed in the capsular bag.
Nourish Organic Renewing & Cooling Eye Treatment  0.5 FL. oz/15 mL
Sensible Organics decided to voluntarily recall Nourish Organic Renewing & Cooling Eye Treatment Lot G06216 due to samples that were tested positive for microbes.
Worldwide Distribution-US (nationwide) including states of: Alabama, Florida, Indiana, Connecticut, California, Wisconsin, Missouri, Florida, Hawaii; and countries of: Sweden and South Africa.
TriMed Semi-Tubular Plate, 10-Hole, Model No. SMTP-10    Contoured plate with offset screw holes. The plate is 103 mm in length, 1.3 mm thick and 9.6 mm wide. The part is made of surgical steel conformance with ASTM F138 or F139. The plate is used to fixation of long bone fractures. The TriMed Bone Plates are intended for use in the fixation of fractures to the Tibia, Fibula, Ulna, Radius and the Humerus.
TriMed is recalling the Semi-Tubular Plates with 10 holes (SMTP-10) because a non-locking screw passed through a hole in a SMTP-10 plate being implanted.
Amoxicillin For Oral Suspension, USP - Dye Free, 400 mg/5 mL, 100 mL (when reconstituted), Rx only,  Manufactured by: Hikma Pharmaceuticals, PO Box 182400, Amman 11118 - Jordan, Distributed by: West-Ward Pharmaceutical Corp. Eatontown, NJ 07724, NDC 00143-9887-01,
Labeling: Label Error on Declared Strength- bottles missing colored coded panel where strength of the product is displayed.
Blood products, collected from a donor who traveled to a malarial endemic area, were distributed.
Apheresis Red Blood Cells, Leukocytes Reduced
W045015020552 (double collection); W045015058685 (double collection)
Pooled platelets, which did not meet acceptable product specifications was distributed.
Nationwide Distribution to CA, GA, and NY
Sage In-Vitro Fertilization- CSC (Choline Substituted Cryopreservation) Thawing Medium   Product Number: ART-8018  Intended for use in freezing embryos. This product is intended for thawing of embryos frozen with ART-8017, CSC Freezing Medium. This kit is designed to be used in conjunction with the SAGE CSC Freezing Medium Kit (ART-8017).
Products contain international package insert and not  the correct USA package insert
Lot no 16140184 expires April 2017  Lot no 15430149 expires Oct. 2016
Sage In-Vitro Fertilization- CSC (Choline Substituted Cryopreservation) Freezing Medium . Product Number:  ART -8017  SAGE In Vitro Fertilization, Inc.  A CooperSurgical Company  95 Corporate Drive  Trumbull, CT 06611 USA
Blood product, not meeting product specifications, was distributed.
Apheresis Platelets, Leukocytes Reduced, Irradiated
Apheresis products, in which quality control for residual WBC count was not performed, were distributed.
Blood and Blood Products for Reprocessing
Blood products, collected from a donor considered to be at increased risk for variant Creutzfeldt-Jakob Disease (vCJD), were distributed.
Penrose-St Francis Health Services Blood Bank
Apheresis product, in which platelet yield did not meet specifications, was distributed.
US nationwide.  The product was distributed to the following states: OH, KS, MN.
Southern Grove Cashews with Sea Salt, a 10 ounce stand up pouch bag with a UPC 0 38445 12286 5 and the date codes of Best By May 24 2017 KN and August 05 2017 KN
This recall has been initiated due to the possible presence of peanuts.
UPC 0 38445 12286 5 and the date codes of Best By May 24 2017 KN and August 05 2017 KN.
Worldwide Distribution: US (nationwide) and countries of: Canada, Australia, Mexico, Belgium, Denmark, Germany, Great Britain, and Sweden.
Sealapex Xpress, Part No. 33639    The brand name of the device is Sealapex Xpress, a root canal filling resin. Sealapex Xpress is intended to be used during endodontic therapy to fill the root canal of a tooth.
SybronEndo is recalling the Sealapex Xpress because it was labeled with an incorrect expiration date of 2017-11 while the syringe was labeled with the correct expiration date of 2016-11.
Blood products, collected from a donor for whom donor suitability was not adequately determined, were distributed.
G1 Dissection Tool - 7mm FBALL L; For cutting and shaping bone including spine and cranium.
Product Code L- 7B-G1 was inadvertently released off of hold status and the affected products were distributed.
G1 Dissection Tool - 3mm CRS DBALL, 2mm SHAFT EXP, M; For cutting and shaping bone including spine and cranium.
The firm discovered on March 4, 2016 that several product codes were inadvertently left off of Hold 1503.
G1 Dissection Tool - 6MM CRS DBALL, 2mm Shaft EXP, M; For cutting and shaping bone including spine and cranium.
G1 Dissection Tool - 3mm FLUTED BALL; For cutting and shaping bone including spine and cranium.
Syngo.via picture archiving and communication system    Syngo via is a software solution intended to be used for viewing, manipulation, communication, and storage of medical images.
Software error.  Incorrect values for the volume calculation from a freehand VOI at the customer site. In volume calculations of prostate as well as in volume calculations of liver were too high.
Syngo.x picture archiving and communication system    Syngo.x is a software solution intended to be used for viewing, manipulation, communication, and storage of medical images.
CADstream software.     Product Usage:  CADstream is an image processing system designed to assist in the visualization, analysis, and reporting of magnetic resonance imaging (MRI) studies. CADstream also is intended to provide workflow efficiency and interventional planning tools.
1,349 sites potentially have the affected versions
An incorrect biopsy or missed target could result if the incorrect grid is selected within the application.
All versions - Versions 4.1.3 and prior versions
Blood product, collected from an ineligible donor, was distributed.
Blood product, collected from a donor whose arm inspection was not adequately documented, was distributed.
Worldwide Distribution - US including AL, AK, AZ, AR, CA, CO, FL, GA, ID, IL, IN, IA, KS,  KY, LA, MD, MA, MI, MN, MS, MO, NE, NV, NH, NJ, NY, NC, OH, OK, PA, RI, SC, SD, TN, TX, VA, WA WV, WI, WY, and Internationally to Canada, France, Great Britain and Ireland
McKesson Radiology, versions 12.1.1 and 12.2       McKesson Radiology (MR) is a Picture Archiving Communication System (PACS). It is a medical image and information management application that is intended to receive, transmit, store, retrieve, display, print and process digital medical images, digital medical video, and associated medical information from various medical imaging systems.
The STAT priority icon was not displayed in the Study List when the study was opened.
McKesson Radiology versions 12.1.1 and 12.2