Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
The product was distributed to 27 Costco stores. There were no foreign consignees.
Elegant sophistication gift basket containing apple cidar in glass bottles. The label on the back of the gift basket is white with black lettering.
According to the recall notification from S. Martinelli, there is a possibility of small glass chips at the top of the bottles occurring when opening the bottle, which could potentially enter the beverage which could result in consumers potentially being cut or injured if a chip occurs.
Gift # where Martinelli 8.4 FL. oz. Sparkling Cider was used F159765-CO   Gift Basket Name Elegant Sophistication  Item # FOD 0110
California, Ohio, Pennsylvania, New York, Colorado, Vermont, Virginia, Florida and Connecticut
Mitica brand PECORINO AGED IN WALNUTS LEAVES (PECORINO FOGLIE di NOCI), SEMI-HARD SHEEP'S MILK CHEESE, Minimum Weight 2 lbs. -- Product of Romagna - Italy --- Imported by Forever Cheese, L.I.C., NY 11106 --- There are 2 wheels of cheese per shipping case.
The Mitica brand Aged Pecorino Cheese may be contaminated with Listeria monocytogenes based on private laboratory testing.
Production Code NOC15313 (found on shipping case only),  invoiced as Lot X2537
Domestic: Jackson, MI; Toledo, OH; Grand Rapids, MI; Urbana, OH; Hudsonville, MI; Columbus, OH; Lansdale, PA; and Charlton, MA.    No Foreign or DOD/VA
PRE-PORTION MASTER DOUGH (PEANUT BUTTER)- Raw cookie dough with 192 pucks/case
Savory Foods Inc. has initiated a voluntary recall due to the potential for contamination with Listeria monocytogenes.
PRE-PORTION MASTER DOUGH (PEANUT BUTTER)- Raw cookie dough with 192 pucks/case; Product Code/Lot Code: 16038
1.5 oz PEANUT BUTTER COOKIES, 80/case; Product Code/Lot Code: 16033
15 units of 18 oz. tubs; and 16 units of 22 oz. tubs.
Sausage, Egg, and Cheese on English Muffin, Fully Cooked, Keep Frozen, Perishable-30/case  Manufactured Exclusively for Starbucks Coffee Company, Seattle, WA 98134  Product Date: 10/FEB/2016  SKU: 11041857  Not Labeled for Retail Sale
Manufactured in a plant where routine environmental swabs tested positive for Listeria monocytogenes on a food contact surface.
Feed was distributed through the firm's own retail stores in located in the state of Missouri.
17% Rabbit Pellet, Guaranteed Analysis *** Salt (NaCl) (min) 0.2 (max) 0.7 %, Packaged in 50 lb (22.6 kg) bags or bulk by truck. Manufactured by MFA Incorporated, Columbia, Missouri 65201
16% Rabbit Shield Pellet, Guaranteed Analysis *** Salt (NaCl) (min) 0.3 (max) 0.8 %, Packaged in bulk by truck. Manufactured by MFA Incorporated, Columbia, Missouri 65201
16% Rabbit Pellet, Guaranteed Analysis *** Salt (NaCl) (min) 0.3 (max) 0.8 %, Packaged in 50 lb (22.6 kg) bags or bulk by truck. Manufactured by MFA Incorporated, Columbia, Missouri 65201
Product distributed to MO.  There was no foreign/military/government distribution.
Bulk grain bank-corn-10920#-Ground #4 Stock Salt.  Manufactured by MFA Agri Services, California, MO 65018.
Product misbranded to contain salt; animal deaths confirmed due to bloat associated with the consumption of the feed.
Domestic only: IN    No Foreign or VA/DOD
Tyson Swine N5 Meal AS; Swine Starter Feed; Bulk product, listed as pounds, 48,500# loaded on trailer
ADM Animal Nutrition, Inc. is voluntarily recalling 48,500 pounds of Tyson Swine N5 medicated animal feed, Product G3039AWO10, due to excessive levels of magnesium; which could result in magnesium toxicity causing symptoms of increased water intake, severe, painful scours, and cardiac arrest leading to death in swine.
US: AL, AZ, AR, CA, CO, CT, FL, IL, IN, IA, KS,KY, LA, ME, MD, MA, MI, MN,  MS,  MO, NE, NV, NM, NY, NC,ND, OH, OK, OR, PA,SC, TN, TX, UT, VA, WA, WI, WY.    OUS: HONDURAS, NICARAGUA, CHILE.
UPC 1373312032,  Meijer White Choc Chip Pretzel Bars, Best By/Date Code:  DEC 09 16.
TreeHouse Foods is recalling products that may be impacted by sunflower seeds  contaminated with Listeria monocytogenes.
UPC 041498200183 Southern Grove Unwind Trail Mix,  Best By/Date Code: 3/28/2017.
UPC 071725712387,	Amport Foods Dark Chocolate Almond, Best By/Date Code: 1/7/2017 .
UPC 075450040586 Hy-Vee Caramel Cashew Honey Crunch Trail Mix., Best By/Date Code:  4/5/2017.
UPC 1373312016,	Meijer Peanut Almond Dark Chocolate Protein Bars, Best By/Date Code:	DEC 07 16.    UPC 1373312016,	Meijer Peanut Almond Dark Chocolate Protein Bars Best By/Date Code:	JAN 07 17    UPC 4130304541,	Essential Everyday Peanut Almond Dark Chocolate Protein Bar, Best By/Date Code:	DEC 07 16.    UPC 7003863812,	Best Choice Peanut Almond Dark Chocolate Protein Bars, Best By/Date Code:	DEC 07 16, JAN 07 17.      UPC 7025322722,	Our Family Peanut Almond Dark Chocolate Protein Bars Best By/Date Code:	DEC 07 16.    UPC 7874203429,	Great Value Peanut Almond Dark Chocolate Protein Bars, Best By/Date Code: 12 06 16, 12 07 16, 01 06 17.    UPC 7989380097,	Eating Right (Lucerne) Peanut Almond Dark Chocolate Protein Bars, Best By/Date Code:	DEC 07 16, JAN 07 17.    UPC 1121302629   Spartan Peanut Almond Dark Chocolate Protein Bars Best By/Date Dec 07 16.
UPC  071725748010,	Sunflower Seeds Roasted and Salted, Best By/Date Code: 11/27/2016.    UPC  007172524140,	Amport Roasted and Salted Sunflower Seeds, Best By/Date Code:11/26/2016.    639277348319,Naturally Select  Roasted and Salted Sunflower Seed, Best By/Date Code: 3/1/2017.    UPC  071725241351,	Amport Foods Sunflower Seeds Roasted & Salted, Best By/Date Code:12/3/2016,12/26/2016, 12/12/2016 .    UPC 071725748010,	Amport Foods Sunflower Seeds Roasted & Salted, Best By/Date Code:12/31/2016,12/26/2016, 1/14/2017 .    UPC 071725241405,	Amport Foods Sunflower Seeds Roasted & Salted, Best By/Date Code:1/7/2017 .
UPC 041498132248,	Southern Grove Oven Roasted Almonds with Sea Salt, Best By/Date Code: 3/16/2017.    UPC 041498132248,	Southern Grove  Dry Roasted Sea Salt Almond,  Best By/Date Code	3/4/2017.    UPC 071725728791,	Nature's Harvest Almond Dry Roasted Sea Salted,  Best By/Date Code	3/16/2017.
UPC 049022832275, 	Nice Sunflower Seeds Salted in Shell, Best By/Date Code: 3/4/2017, 4/15/2017.
UPC 071725748034,	Amport Foods Yogurt Almonds, Best By/Date Code: 1/8/2017 .
UPC 071725728166, 	Natures Harvest Afternoon Snack Blend, Best By/Date Code: 11/28/2016.
UPC 070038614142, 	Best Choice Mountain Trail Mix,  Best By/Date Code: 3/14/2017.    UPC 041498148447, Southern Grove Mountain Trail Mix, Best by Date Code: 4/4/2017, 4/26/2017.    UPC 075450016796, 	Hy-Vee Mountain Mix Trail Mix,  Best By/Date Code: 4/5/2017, 4/15/2017.    UPC 075450040739, 	Hy-Vee Mountain Trail Mix,  Best By/Date Code: 3/23/2017.
UPC 070038638285,  Best Choice Dark Chocolate Cranberry,  Best By/Date Code: 3/14/2017
UPC 041498131500,	Southern Grove Chopped Walnuts , Best By/Date Code: 3/22/2017.
UPC 041498177829,	Southern Grove Nuts, Seeds & Raisins Trail Mix , Best By/Date Code: 3/23/2017, 4/13/2017.
UPC 2113028372,  Signature Kitchen Peanut Chocolate Chunk Bars , Best By/Date Code: Dec 09 16.
UPC 1115099114	Roundy Peanut Butter Dark Chocolate Bars, 	Best By/Date Code: DEC 05 16, JAN 04 17.
Best By/Date Code: DEC 05 16, JAN 04 17.
UPC 639277286208	Salted Sunflower Seeds in Shell distributed by Greenbrier International, Inc., Best By/Date Code:2/25/2017,  2/28/2017,3/17/2017, 3/21/2017, 4/13/2017.
UPC 049022846524 Nice! Peanut Lovers Trail Mix., Best By/Date Code:  4/19/2017.
UPC 071725750167 Clover Valley Chocolatey Peanut Butter Trail Mix., Best By/Date Code:  3/25/2017 .
UPC 1373312031,  Meijer Peanut Chocolate chunk Pretzel Bars, Best By/Date Code: DEC 09 16.
UPC 071725728203 Nature's Harvest Sweet Nut & Berry Munch Trail Mix,  Best By/Date Code: 12/27/2016.
Sunflower Kernels packaged in the following brands and sizes:      UPC 041498206680, Southern Grove Roasted and Salted Sunflower Kernels,   Best by/Date: 3/1/2017, 3/2/2017, 2/28/2017, 3/15/2017,3/28/2017, 4/29/2017 .    UPC 071725727497, Natures Harvest Roasted and Salted Sunflower Kernels, Best by/Date: 11/25/2016, 12/4/2016, 3/1/2017, 12/19/2016,12/20/2016, 12/25/2016, 1/2/2017,  1/3/2017, 1/16/2017, 1/20/17 .    USPC 883967300013,	Smart Sense Roasted and Salted Sunflower Kernels, Best by/Date: 3/4/2017.    USPC 050428353240,	Gold Emblem Roasted and Salted Sunflower Kernels, Best by/Date: 11/27/2016, 1/14/2017.    USPC 883967300013,	Smart Sense Roasted Salted Sunflower Kernels, Best by/Date: 3/16/2017.
UPC 1115029456,	Roundy Sweet and Salty Almond Chewy Bars, Best By/Date Code:	DEC 08 16.    UPC 1116103436,	ShurFine Sweet and Salty Almond Chewy Bars, Best By/Date Code:	DEC 08 16.    UPC 1373312025,	Meijer Sweet and Salty Almond Bars, Best By/Date Code:	DEC 07 16, DEC 08 16.    UPC 1540016425,	Western Family Sweet and Salty Almond Bars,Best By/Date Code :	DEC 07 16.    UPC 2113028352,	Signature Kitchen Sweet & Salty Almond Bars, Best By/Date Code:  	Dec 08 16.    UPC 3680017921	Food Club Sweet and Salty Almond Bars, Best By/Date Code:  	DEC 07 16, DEC 08 16.    UPC 4130300139	Essential Everyday Sweet and Salty Almond Bars, Best By/Date Code:	DEC 08 16.    UPC 7025322712	Our Family Sweet and Salty Almond Bars, Best By/Date Code:	DEC 08 16.    UPC 7078447470	Tops Sweet and Salty Almond Bars, Best By/Date Code:	DEC 07 16.    UPC 7874207499.	Great Value Sweet & Salty Almond Bars, Best By/Date Code:	12 08 16, 	12 09 16.    UPC 8826749280	FoodHold Sweet and Salty Almond Bars,Best By/Date Code	DEC 07 16.    UPC 1121306657       Spartan Sweet and Salty Almond Bars, Best By/Date Dec 08 16.
UPC 049022880634 Delish Tropical Blend Premium Trail Mix., Best By/Date Code:  3/17/2017.
UPC 071725750211,  Natures Harvest Pecans, Best By/Date Code :   3 /4/2017
UPC 071725749314 Nature's Harvest Dark Chocolate Covered Cashews,  Best By/Date Code: 1/6/2017.
UPC 041498202057 Southern Grove Sunny Cranberry Trail Mix,  Best By/Date Code: 3/28/2017.
UPC 075450040593 Hy-Vee Berry Trail Mix., Best By/Date Code:  3/19/2017.
UPC 071725714688, 	Raisin and Nut Trail Mix, Best By/Date Code:11/28/2016.
UPC 071725711854,	Amport Foods Dark Chocolate Cranberry Trail Mix, Best By/Date Code: 1/2/2017 .    UPC 075450041354,	Hy-Vee Dark Chocolate Cranberry Trail Mix, Best By/Date Code: 4/14/2017 .    UPC 071725749062,	Nature's Harvest Dark Chocolate Cranberry Trail Mix, Best By/Date Code: 3/28/2017.
UPC 4130300137,  Essential Everyday Trail Mix Bars, Best By/Date Code: JAN 04 17.
UPC 071715727510 Nature's Harvest Sunflower Kernels Honey Roasted., Best By/Date Code:  12/20/2016, 1/21/2017.
UPC 049022880641 Delish Blueberry Nut Blend Premium Trail Mix., Best By/Date Code:  3/17/2017.
UPC 639277187567,	Naturally Select Indulgent Trail Mix, Best By/Date Code: 3/24/2017 .
UPC 7003860349,  Best Choice Trail Mix Fruit and Nut Bars Best By/Date Code: JAN 04 17.
UPC 041498211004,	Southern Grove PB & Pretzel Trail Mix, Best By/Date Code: 3/28/2017,4/5/2017 .
UPC 071725741042,	Amport Foods Trail Mix Raisin & Nut, Best By/Date Code: 4/4/2017 .    UPC 071725714688,	Amport Foods Trail Mix Raisin & Nut, Best By/Date Code: 1/14/2017 .
UPC 041498205379,	Southern Grove Tuscan Trail Mix, Best By/Date Code: 4/28/2017 .
UPC 071725750198, Natures Harvest  Whole Almonds,  Best By/Date Code: 	3/3/2017  UPC 071725750266,	Natures Harvest  Slivered Almond,  Best By/Date Code: 	3/3/2017  UPC 071725750259,	Natures Harvest Sliced Almonds, Best By/Date Code: 	3/4/2017    UPC 041498121686, Southern Grove Sliced Almonds, Best By/Date Code:3/21/2017
UPC 411014937907,	Fresh Finds Dried Tropical Mix, Best By/Date Code: 3/17/2017 .
UPC 639277431455,	Naturally Select Fruit & Nut Trail Mix, Best By/Date Code: 3/15/2017 .
UPC 032251046506 Family Gourmet Tropical Mix., Best By/Date Code:  3/16/2017 .
UPC 071725728166 Nature's Harvest Afternoon Trail Mix., Best By/Date Code: 1/14/2017.
UPC 071725241412,	Amport Foods Sunflower Seeds Roasted, Best By/Date Code: 11/26/2016 .    UPC 071725241504,	Amport Foods Sunflower Seeds Roasted, Best By/Date Code: 12/2/2016,12/25/2016, 12/11/2016  .      UPC 071725748003,	Amport Foods Sunflower Seeds Roasted & Unsalted, Best By/Date Code: 12/3/2016,1/6/2017  .    UPC ,071725748003, 	American Importing Company. Inc., Roasted No Salt Seeds , Best By/Date Code: 1/6/2017.
UPC 041498160982,	Southern Grove Cranberry & Nut Trail Mix , Best By/Date Code: 3/24/2017, 4/15/2017    UPC071725706133,  Amport Foods Cranberry Nut Trail Mix, , Best By/Date Code: 3/18/2017, 4/14/2017.
UPC 049022880627 Delish Almond Berry Pistachio Premium Trail Mix., Best By/Date Code:  3/18/2017.
UPC 071725711939,	Amport Foods Milk Chocolate Peanuts, Best By/Date Code: 1/7/2017 .
UPC 071725728074, 	Natures Harvest Sunflower Kernels Ranch Flavored,  Best By/Date Code: 3/1/2017, 3/31/2017, 4/27/2017.
UPC 1373312015,  Meijer Peanut Butter Dark Chocolate Protein Bars,Best By/Date Code:  DEC 05 16,  JAN 04 17.    UPC 3225108607, Family Gourmet Peanut Butter Dark Chocolate Protein ,Bars Best By/Date Code: JAN 04 17.    UPC 3680039453,	Food Club Peanut Butter Dark Chocolate Protein Bars,Best By/Date Code: DEC 05 16, JAN 04 17.    UPC 4130304540,	Essential Everyday Peanut Butter Dark Chocolate Protein Bars,  Best By/Date Code:	DEC 05 16, JAN 04 17.    UPC 5042847944 , Gold Emblem Peanut Butter Dark Chocolate Protein Bars ,Best By/Date Code:  DEC 05 16, JAN 04 17, JAN 05 17.    UPC 7003863811, Best Choice Peanut Butter Dark Chocolate Protein Bars,Best By/Date Code: DEC 05 16,  JAN 04 17.    UPC 7025322720, Our Family Peanut Butter Dark Chocolate Protein Bars,Best By/Date Code: DEC 05 16, JAN 04 17.    UPC 7078447478,  Tops Peanut Butter Dark Chocolate Protein Bars, Best By/Date Code: JAN 04 17.    UPC 7874203428,  Great Value Peanut Butter Dark Chocolate Protein Bars, Best By/Date Code: 12 05 16, 12 06 16, 01 05 17, 01 06 17.    UPC 7989380098,  Eating Right (Lucerne) Peanut Butter Dark Chocolate Protein Bars, Best By/Date Code: DEC 05 16, JAN 05 17.
UPC 041498114749,	Southern Grove  Dry Roasted No Salt Almond,  Best By/Date Code	3/4/2017.
UPC 071725713124,	Amport Foods Chocolatey Nut Trail Mix, Best By/Date Code: 1/8/2017 .    UPC 639277431417,	Naturally Select Chocolate & Nut Trail Mix, Best By/Date Code: 3/23/2017 .
UPC 075450041101Hy-Vee Santa Fe Trail Mix., Best By/Date Code:  3/31/2017.
UPC 041498200190,	Southern Grove Adventure Trail Mix , Best By/Date Code: 3/28/2017.
Product was shipped to the following states: AL, AR, GA, IL, IN, KS, KY, MI, MO, MS, NC, NE, OH, SC, TN, TX, VA & WV.
Kroger Broccoli Raisin Salad, INGREDIENTS: Broccoli, dressing***sugar,. contains less than 2% sunflower seeds, golden raisins, raisins, lime juice, xanthan gum. DIST BY THE KROGER COMPANY CINCINNATI, OHIO 45202 UPC  002871 58200 0.
Firm was notified by their supplier that the product may be contaminated with Listeria monocytogenes.
Four Seasons Pecan Tarts;   202 4T0867 ; Sel By: 09/10/2016, 09/15/15, 10/13/16,10/28/16; and   12/10/15, 12/15/15, 01/13/16, 01/28/16 (lot numbers).     180 Pieces; Weight 8#;   Packed exclusively for International Market Brands, Cleveland, Ohio  44146.
bulk, food service, Four Season Pecan Tarts contain undeclared milk.
Product label states name and ingredients as Octopus and real content is Squid.
Sprite Zero, 12 oz. can/12 pack, UPC 049000037111; Sprite, 12 oz. can/6 pack, UPC N/A; Sprite, 12 oz. can/12 pack, UPC 049000028928; Sprite, 12 oz. can/20 pack, UPC 049000014655
Diet Dr Pepper, 12 oz. can/24 pack, UPC 078000083132; Diet Dr Pepper, 12 oz. can/6 pack, UPC N/A; Diet Dr Pepper, 12 oz. can/20 pack, UPC 078000083095; Dr Pepper, 12 oz. can/6 pack, UPC N/A; Dr Pepper , 12 oz. can/ 20 pack, UPC 078000082098; Dr Pepper 12 oz. can/ 12 pack, UPC 078000082166; Dr Pepper, 12 oz. can/24 pack, UPC 078000082135
APOMORPHINE HCL (VET) 3MG/ML INJECTABLE  Sterile Glass Vials - 5ML  Refrigerated  Well Care Compounding Pharmacy  Las Vegas, NV
Firm is performing a recall on all unexpired sterile compounded products due to concerns of lack of sterility assurance.
CYCLOSPORINE (A) (VET) 1% OIL OPTH Soln  15 mL  Sterile Droptainer  Room Temp  Well Care Compounding Pharmacy  Las Vegas, NV
TACROLIMUS OPTH (AQ) 0.02 SOLUTION  Sterile Dropper  Refrigerated  Well Care Compounding Pharmacy  Las Vegas, NV
CYCLOSPORINE (PF) l% OPTH SUSP (15 mL)   Sterile Droptainer  Room Temp  Well Care Compounding Pharmacy  Las Vegas, NV
CYCLOSPORINE (A) (VET) 2% OIL OPTH SOLUTION (15mL)  Room Temp  Well Care Compounding Pharmacy  Las Vegas, NV
US Nationwide Distribution in the states of:  AK, AL, AZ, CA, CO, CT, FL, IA, IL, IN, KS, LA, MA, MD, MI, MN, MO, NC, ND, NE, NJ, NY, OH, OR, PA, TN, TX, UT, VA, WA, and WI.
Zenostar MT Color Impulse blue, Art. no. 681165    Product Usage:  For coloring dental porcelain
The primary packaging of these products may show leaks in individual cases. As a consequence, the liquid may escape inadvertently and direct contact with this liquid may lead to skin irritation.
Lot No: U54839, expiration date: Jan 25 2018; Lot No: U51735, expiration date: Nov 11 2017; Lot No: U49940, expiration date: Nov 2 2017; Lot No: U44391, expiration date: Oct 19 2017 and Lot No: U39253, expiration date: Sep 20 2017
Zenostar MT Color Impulse brown, art. no. 681169    Product Usage:  For coloring dental porcelain
Lot No: U44405, expiration date: Oct 19 2017; U39262, expiration date: Sep 20 2017
Zenostar MT Color B2 60ml, art. no. 681056.      Product Usage:  For coloring dental porcelain
Zenostar MT Color C4 60ml, art. no. 681062.      Product Usage:  For coloring dental porcelain
Zenostar MT Color D3 60ml, art. no. 681064.     Product Usage:  For coloring dental porcelain
Zenostar MT Color A4 60ml, art. no. 681054.     Product Usage:  For coloring dental porcelain
Zenostar MT Color Impulse orange, art. no. 681168.      Product Usage:  For coloring dental porcelain
Lot No: U44402, expiration date: Oct 19 2017; V01767, expiration date:  Jan 18 2018; U52968, expiration date: Jan 18 2018; U53010, expiration date: Nov 16 2017; and U38982, expiration date: Sep 17 2017
Zenostar MT Color D4 60ml, art. no. 681065.     Product Usage:  For coloring dental porcelain
Zenostar MT Color A3 60ml, art. no. 681052.      Product Usage:  For coloring dental porcelain
Lot No: U49683, exp date: Nov 2 2017; U49656, exp date: Nov 2 2017; and U39116, exp date: Sep 17 2017
Zenostar MT Color B4 60ml, art. no. 681058.   Product Usage:  For coloring dental porcelain
Zenostar MT Color C1 60ml, art. no. 681059.     Product Usage:  For coloring dental porcelain
Zenostar MT Color Impulse violet, art. no. 681166    Product Usage:  For coloring dental porcelain
Zenostar MT Color B1 60ml, art. no. 681055.     Product Usage:  For coloring dental porcelain
Zenostar MT Color C2 60ml art. no. 681060.     Product Usage:  For coloring dental porcelain
Lot No: U44095, exp date: Oct 19 2017 and U38600, exp date: Sep 15 2017
Zenostar MT Color C3 60ml, art. no. 681061.   Product Usage:  For coloring dental porcelain
Zenostar MT Color D2 60ml, art. no. 681063.     Product Usage:  For coloring dental porcelain
Lot No: U43930, exp date: Nov 2 2017 and U39238, exp date: Sep 20 2017
Zenostar MT Color A2 60ml, art. no. 681051.     Product Usage:  For coloring dental porcelain
Zenostar MT Color Impulse grey, art. no. 681167    Product Usage:  For coloring dental porcelain
Zenostar MT Color B3 60ml, art. no. 681057.     Product Usage:  For coloring dental porcelain
Zenostar MT Color A1 60ml, art. no. 681050,     Product Usage:  For coloring dental porcelain
Zenostar MT Color A3.5 60ml, art. no. 681053.     Product Usage:  For coloring dental porcelain
Lot No: U49659, exp date: Nov 2 2017; U43928, exp date: Oct 19 2017; and U38672, exp date: Sep 15 2017
distributed nationwide except HI and MS and in Canada
Frozen Rad Cat Raw Diet Free-Range Turkey,  8 oz, UPC 851536001005.  Frozen Rad Cat Raw Diet Free-Range Turkey, 16oz, UPC 851536001012.   Frozen Rad Cat Raw Diet Free-Range Turkey, 24oz, UPC 851536001029.
Frozen Rad Cat Raw Diet Free-Range Turkey product is recalled due to the potential to be contaminated with Salmonella and/or Listeria monocytogenes.
Lot Code 62372, Best By Date: 01/21/2017
Frozen Rad Cat Raw Diet Free-Range Chicken, 8 oz, UPC 851536001036.  Frozen Rad Cat Raw Diet Free-Range Chicken, 16oz, UPC 851536001043.   Frozen Rad Cat Raw Diet Free-Range Chicken, 24oz, UPC 851536001050.   Frozen Rad Cat Raw Diet Free-Range Chicken, 1oz samples.
2869 containers total and 540/1 oz. sample cups
Frozen Rad Cat Raw Diet Free-Range Chicken product is recalled due to the potential to be contaminated with Salmonella and/or Listeria monocytogenes.
Lot code 62416, Best By Date: 03/14/2017
Frozen Rad Cat Raw Diet Grass-Fed Beef, 8 oz, UPC 851536001241.  Frozen Rad Cat Raw Diet Grass-Fed Beef, 16oz, UPC 851536001258.   Frozen Rad Cat Raw Diet Grass-Fed Beef, 24oz, UPC 851536001265.   Frozen Rad Cat Raw Diet Grass-Fed Beef, 1oz samples.
7739 containers total and 3600/1 oz. sample cups
Frozen Rad Cat Raw Diet Grass-Fed Beef product is recalled due to the potential to be contaminated with Salmonella and/or Listeria monocytogenes.
Product is in a White and Green 50lb. paper bag, PURINA LAMB GROWER B30 MEDICATED Type C Medicated Feed COMPLETE FEED FOR GROWER SHEEP. 30.00 g/ton Lasalocid. Manufactured by Purina Animal Nutrition LLC.
Lot Number: 6May06WCH2  Item No. 1850500-206  Product Code:  L329
TriFoillmaging Triumph/Triumph II Research CT scanners.
The Firm has determined that several Triumph/Triumph II Research CT scanners produced by Northridge Trimodality Imaging, inc dba TriFoillmaging (or by Gamma Medica-Ideas, Inc and field upgraded with a replacement  x-ray tube) may be out of compliance with 21 CFR 1020.40 (Cabinet X-ray standards)
Claravis (isotretinoin capsules USP), 10mg,  packaged in carton containing 3 Blister Packs of 10 Capsules Each (30 Capsules total); Rx only, TEVA PHARMACEUTICALS USA, Sellersville, PA 18960. NDC 00555-1054-86
US Distribution to the states of: PA,  IA, MA, SD, MI, LA, KY, NC, NY, AR, IN, WI, OH, TY, FL, WV, WA, CT, MS, AL, ND, CO, HI, NO, MN, ID, OH, GA, MT, LA, NM, VT, TN, CA, NH, NJ, NE, SC and KS.
Toshiba America Medical Systems, Inc .  Celesteion PCA-9000rV2 CT Scanner
It has been found that if the scan range extends beyond the maximum Field of View (FOV), a reconstruction operation error may occur. As a result, scanning may be interrupted and rebooting of the system may be necessary. Please note that this issue has not occurred in the U.S.
Toshiba America Medical Systems, Inc  Aquilion Lightning TSX-035A  CT Scanner.
Toshiba America Medical Systems, Inc .  Aquilion RXL  TSX-1 01 AIR, U CT Scanner    Diagnostic imaging systems indicated to acquire and display cross sectional volumes of the whole body, to include the head.
Toshiba America Medical Systems, Inc .  Aquilion LB  TSX-201A/2, 3 CT Scanner
Ultra-Soy Textured Vegetable Protein-BS104, packaged in a 50lb bag, most responsible firm name on label is CHS Inc. Hutchinson, KS 67501 1-800-835-5006
Copacker notified firm of positive results for Salmonella in finished product testing.
Ultra-Soy Imitation Bacon Flavored Chiplets-B100, packaged in a 25lb box, most responsible firm name on label is CHS Inc. Hutchinson, KS 67501 1-800-835-5006
Ultra-Soy Imitation Bacon Flavored Chips-B162, packaged in a 25lb box, most responsible firm name on label is CHS Inc. Hutchinson, KS 67501 1-800-835-5006
Ultra-Soy Imitation Bacon Flavored Bits-B163, packaged in a 25lb box, most responsible firm name on label is CHS Inc. Hutchinson, KS 67501 1-800-835-5006
Ultra-Soy Textured Vegetable Protein (Red Chips)-BS140, packaged in a 50lb bag, most responsible firm name on label is CHS Inc. Hutchinson, KS 67501 1-800-835-5006
Ultra-Soy Textured Vegetable Protein (Red Chips)-BS135, packaged in a 50lb bag, most responsible firm name on label is CHS Inc. Hutchinson, KS 67501 1-800-835-5006
Ultra-Soy Textured Vegetable Protein (Red Bits)-BS138, packaged in a 50lb bag, most responsible firm name on label is CHS Inc. Hutchinson, KS 67501 1-800-835-5006
Ultra-Soy Textured Vegetable Protein (Red Chiplets)-BS100, packaged in a 50lb bag, most responsible firm name on label is CHS Inc. Hutchinson, KS 67501 1-800-835-5006
Lot number 16181, exp Jun 29, 2018  Lot number 16182, exp Jun 30, 2018
Ultra-Soy Imitation Bacon Flavored Chiplets-B106, packaged in a 25lb box, most responsible firm name on label is CHS Inc. Hutchinson, KS 67501 1-800-835-5006
McCormick Code 601091 Imitation Bacon Flavored Granules-B130, packaged in an 850lb tote, most responsible firm name on label is CHS Inc. Hutchinson, KS 67501 1-800-835-5006
Worldwide Distribution - US Nationwide in the states of KY, CA, NY, DC, NC, TX, IL, OH, IL, FL, IK, IA, MS and countries of Mexico, Taiwan, Guatemala, Malaysia, Argentina, Dominican Republic, Philippines, Germany, Australia.
Thermo Scientific QMS Everolimus Assay;  Model number:  0380000 (US Distribution);  0373852 (Foreign Distribution)    Product Usage:  The QMS Everolimus Assay is intended for the quantitative determination of Everolimus, in human whole blood on automated clinical chemistry analyzers. The results obtained are used as an aid in the management of kidney and liver transplant patients receiving Everolimus therapy. This in vitro diagnostic device is intended for clinical laboratory use only. The QMS Everolimus assay is intended to be used as an aid in the management of patients receiving everolimus therapy for those organ transplant procedures indicated in the chart for each specific country.
163 kits in US, 669 kits worldwide - toatal 831.
Distributed Nationwide and the countries of : Austria, Bahamas, Belgium, Canada, Czech Republic, Denmark, Germany, Italy, Japan, Netherlands, Portugal, Saudi Arabia, South Korea, Slovenia, and Spain.
Siemens Healthcare Diagnostics determined that the Dimension Vista Calcium (CA) Flex reagent cartridge lot # 16060BB may produce erroneously low or high results from specific well sets.
Device Listing No: D011443  Batch Number 16060BB
Walrus Arterial Embolectomy Catheter    The arterial embolectomy catheter is intended for use in removing arterial emboli.
Arrow  is  recalling  due  to  incorrect  labeling  of  products.
US Nationwide Distribution including Puerto Rico
Panoramic X-ray Model PC-1000, Laser-1000 packed in a crate    Product Usage:  The PC-1000 will enable the user to take panoramic x-ray images. The PC-1000/Laser1000 will enable the user to take panoramic x-ray images as well as cephalometric x-ray images.
Panoramic Corporation is performing a voluntary Medical Device Correction on certain PC-1000 X-ray systems due to the potential for a safety nut to be ineffective, which could result in blunt force trauma that may impact the head, neck or shoulders.
Nationwide to U.S. consignees located in the following states:AL ,AR ,AZ ,CA ,CT ,FL ,GA ,IL ,IN ,KY ,LA ,MA ,MD ,MI ,MO ,NC ,NJ ,NM ,NV ,NY ,OH ,PA ,SC ,TX ,UT ,VA ,WA and WV.
BLUE IMPERVIOUS GOWN WITH THUMBHOOKS, X-LARGE. Non-Sterile, Single Use Only, Plastic Non-Surgical Isolation Gown Non-Sterile, Single Use Only, Plastic Non-Surgical Isolation Gown. Serves as physical barrier to the transfer of microorganisms, body fluids and particulate material. Level of barrier protection is nonspecific.   An isolation gown covers the torso and clothing and poses a physical barrier to the transfer of microorganisms, body fluids and particulate material
Blue Impervious Gown with thumbhooks, X-large. All lots do not meet design specifications, specifically 16 CFR 1611 - Standard for the Flammability of Vinyl Plastic Film. The standard defines a specific test method that quantifies the rate of flame propagation against a minimum value using an engineered test fixture. The method requires that the test be performed on different orientations of the film (machine direction and cross direction). The machine direction is defined by the manufacturing process generating the film. The formed film exits the machine moving in the machine direction. The cross direction is at 90 degrees to the machine direction. The more rapid burning direction defines the results of the test (either a pass or fail). The products being recalled failed when tested in the machine direction with a result of 1.9-2.0 inches/second versus a limit of 1.2 inches/second. They passed by self-extinguishing when tested in the cross direction.
All Lots with material number 5213PG and V5213PG
American Natl Red Cross Mid Atlantic Region
Ohio; Pennsylvania; Indiana; West Virginia; Virginia
Blood products, collected in a manner with a potential for air contamination, were distributed.
Red Blood Cells, Leukocytes Reduced, Irradiated
Patti's good life PREMIUM APPLE PECAN CAKE, NET WT 20 OZ (1 LB 4 OZ) 567g, UPC 89028800290
Apple Pecan Cake, which was labeled correctly on the principle display panel, was labeled with the incorrect UPC and ingredient statement, which did not declare pecans.
Worldwide Distribution - US (Nationwide) and countries of: Austria, Belgium, Czech Republic, Denmark, Finland, Germany, Netherlands, Norway, Portugal, Spain, Sweden, Switzerland, and United Kingdom.
0.2 Micron Filter, 50 mm    Product Usage:  The 0.2 Micron Filter is a bacteria and particulate filter for aqueous solutions. It attaches to a standard Baxter Pharmacy Pump Tube Set.
Baxter Healthcare Corporation is issuing a voluntary product recall for all unexpired lots of the 50mm 0.2 Micron Filter (Product Code: H93835) due to the potential for the filter membrane layer to be missing and for particulate matter to be present.
North Carolina; Indiana; Virginia; South Carolina; Georgia
Blood products, possibly contaminated with air, were distributed.
ReNew (a.k.a. Trio)    Dermatology:  for use in dermatology for incision, excision, ablation and vaporization with hemostasis of soft tissue;  for use in the treatment of fine lines and wrinkles;  for treatment of back acne and atrophic acne scars;  for treatment of reflux of the great and small saphenous veins associated with varicose veins and varicosities, and; for laser assisted lipolysis
FDA inspection found that customers who had received devices with promotional material  with outside use indications were not notified when labeling was revised to remove these indications.
Serial numbers:  ABKK03  ABKK04  ABKM02  ABSG01  ABUP01.
CT3Plus (a.k.a. CT3PZ);  Catalog number: 7300-0038/ 7300-0038-1.      Dermatology: For use in dermatology for incision, excision, ablation, and vaporization with hemostasis of soft tissue;  For treatment of fine lines and wrinkles;  For mild to moderate inflammatory acne vulgaris;  For back acne and atrophic scarring, and;  For podiatry, (incision, excision, and coagulation of soft tissue), including.  matrixectomy, periungal and subungal warts, plantar warts,  radical nail excision, and neuromas
Serial numbers CT3Plus:   4009  4023  ABB0271  4030  4016  ABB0900  ABC0363  BBC1457  ABB0862  ABD0757  ABD1363  ABE0101  ABE1258  BBE1875  ABC1193  BBG1209  ABH1818  ABC1067  ABK2803  ABM0371  ABM1206  ABP1160  ABS1067  ACA1652  ACA1790  ACA2139  ACC1485  ACD0843  ACC1158  ACA1333  ABB0388  SEM02  SEM07  ABB0423  ABE1663  4014  UHG01  UHM02  ABS1761  ABC0921  ABF0613  3045  ABM1410  ABC1252.    Serial numbers CT3PZ:  ACA1011  ABD0501  UKH01-Z  ADMS01  ADMS02  ADMS03  ADPA01  ADPA02  ABS1353-Z  ADPD02  ADPD03  ADPD04  ADPD05  ADPD06  ADPE01  ADPE02  ABM1999  ADPE06  ADPE05  ADPG01  ABP1509  ADPH01  ADPH02  ADPH04  ADPH05  ADPH06  ADPH07  ADPE04  ADPK01  ADPK04  ADPK05  ADPK07  ADPM03  ADPP02  ADSB01  3023  4004  ACD1006  4002-Z  ACD1621-Z  ADSP01  UHK01-Z  ADSS04  ADTE01  ADTG01  ABS1171-Z  ADUE01.
VariaBreeze; Catalog number: 7300-0035-2.      Podiatry:  ablation, vaporization, incision, excision, and coagulation of soft tissue including matrixectomy, periungal and subungal warts, plantar warts, radical nail excision, and neuromas.  The temporary increase of clear nail in patients with onychomycosis (e.g., dermatophytes Trichophyton rubrum and T. mentagrophytes, and/or yeasts Candida albicans, etc.)
Serial numbers:  XSB02-VB  AESB01  AHSF02  AHSF04  AHSF05  AHSF06  AHSF07  AHSF08  AHTE01  AHSF03  AHTF01  AHTF02  AHTH01  AHTM02  AHTM01  AHTS01  AHTS03.
OR, NY, MN, KY, CA, ID, CO, MA, and FL.  Thailand.
The device was assembled incorrectly. Suture and washer were not assembled; components were placed loose in the package.
Unique Device Identifier (UDI):  00888867118607;   Catalog # AR-7000-18T; Batch #10028617.
Blood Centers of the Pacific - Irwin Center
Blood products, labeled with an incorrect expiration date, were distributed
Blood Bank Of San Bernardino And Riverside Counties
Apheresis Red Blood Cells, Leukocytes Reduced
Blood products, collected using equipment that required requalification/validation before returning to service, were distributed.
Blood and Blood Products for Reprocessing
Blood products, collected from a donor who was at risk for variant Creutzfeldt-Jakob disease (vCJD), were distributed.
Blood products, collected from a donor in which donor suitability was not adequately determined, were distributed
US - CA, WA, UT, AZ, OR, FL, TX, HI, ID, OK, GA, IN, PA, MI, IL, SD, MN, KS, MO, NJ, LA, WI, KY, VA, MD, NY, and CT.
Product may be potentially contaminated with Salmonella.
CUSA Dissectron Fingertip Laparoscopic Cannula, REF F75221, Sterile EO, Rx only, packaged in a Tyvek pouch and secondary packaged in Tyvek pouch, Five (5) sealed pouches are packaged in a cardboard box.   For use with CUSA DISSECTRON Hand pieces and Sontrodes
During final sampling inspection, one of the lots was discovered with a total incomplete packaging seal of the sterile product.
Catalog Number F75221, Lot #0195486 with expiry 04/2021
Integra Ventricular Catheter Accessory Kit, REF 951303, Sterile EO, Rx only, packaged in a PVC tray, then secondary package in to Tyvek pouch and tertiary packaged in to Tyvek pouch. Sealed pouches are packaged in a cardboard box.   F8 35cm Silicone Elastomer Ventricular Catheter for use with CSF external drainage systems
Catalog Number 951303, Lot #0195786 with expiry 05/2019
Integral Lumbar Drainage Set, REF 910420, Sterile EO, Rx only, primary packaged in a PVC blister sealed with Tyvek sheet and secondary packaged in to Tyvek pouch. Internal drainage set is primary packaged in a Tyvek pouch and secondary packaged in to Tyvek pouch, One (1) sealed package of lumbar catheter and Internal drainage set are finally packed in a cardboard box. Intended for CSF external drainage
Catalog Number 910420, Lot #0195878 with expiry 10/2018
Integra Drainage Accessory Kits, REF 910122, Sterile EO, Rx only, packaged in one Tyvek pouch. Five (5) sealed Tyvek pouches are packaged in a cardboard box.   Used for Intraoperative drainage of CSF
Catalog Number 910122, Lot #0195615 with expiry 04/2019
Integra Lumbar Drainage Set, REF 910120A, Sterile EO, Rx only, primary packaged in a PVC blister sealed with Tyvek sheet and secondary packaged in to Tyvek pouch. External drainag system is primary packaged in a Tyvek pouch and secondary packaged in to Tyvek pouch. One (1) sealed package of lumbar catheter and External drainage system is finally packaged in a cardboard box. Intended for CSF external drainage
Catalog Number 910120A, Lot #0195870 with expiry 05/2019
Integra Straight Ventricular Catheter F8, 25 cm, Sterile EO, Rx only, packaged in a Tyvek pouch and secondary packaged in to Tyvek pouch, sealed in a cardboard box.   Silicone elastomer Ventricular Catheter for use with hydrocephalus valves
Catalog Number VC-1, Lot #0195451 with expiry 05/2019
US Distribution to states of: GA, OR, FL, KY, NC, AR and PA.
ROI-A Anterior Delivery Device.  Orthopedic manual surgical instrument. Model number: SI-ROIA-0023    Auxiliary instrument used in the ROI-A-ALIR cage system: Spinal intervertbral body fusion device.
The ROI-A Anterior Delivery Device T-Handle, part number SI-ROIA-0023 has experienced binding of the rotation of the t-handle.  There have been no reports of patient injury
Department of the Army, Tripler Army Medical Center
Blood products, collected using expired blood collection bags, were distributed.
American Red Cross Blood Services Tennessee Valley Region
Blood products, which did not meet the acceptable product specification, were distributed.
Apheresis Platelets, Leukocytes Reduced, Irradiated
Apheresis Red Blood Cells, Leukocytes Reduced, Irradiated
Blood products, which may have been exposed to unacceptable temperatures during storage, were distributed.
The American National Red Cross - Southern Region
Blood product, in which labels applied to blood unit or product incorrect or missing information were distributed.
Blood product, collected from a donor who had been incarcerated, was distributed.
New York, New Jersey, Pennsylvania, Virginia, Maryland, and Massachusetts
Wegmans ITALIAN CLASSICS RICOTTA & SPINACH STRIPED JUMBO RAVIOLI, NET WT 9 OZ. (255g), UPC 0-77890-38934, KEEP REFRIGERATED -- Distributed By: Wegmans Foods Markets, Inc. Rochester, NY 14603, Product of Canada --- Packaged in a plastic tray and sold in a refrigerated case in the dairy department.
Product may contain pieces of white plastic.
Use or freeze by date of Sept. 30, 2016 (sold in Wegmans stores between Tuesday, Aug. 2 and Tuesday, Aug. 30, 2016)
AL FL IA  NY OH MI MN MD NJ NY  PA SC & VA
Yu Yee Brand Black Pepper Powder, Net Wt. 19.4 oz (550g), UPC 0 23452 06084 2, Packed for Summit Import Corp., Jersey City, NJ 07305, Product of China
Yu Yee Brand Black Pepper Powder may be contaminated with Salmonella.
Nationwide:  Foreign:  Canada, Bahamas,Germany, Japan, Mexico.Belgium, Italy,Spain, Korea, France, Austria, Korea, France, Poland, Australia, china, AE, Bangladesh, Columbia, Czechkoslovakia, Bosnia
Siemens RAPIDPoint 400 Measurement Cartridge   Siemens SMN numbers:10329756, 10341161
Error in the value assignment for the Chloride calibrators in the RAPIDPoint 400 and RAPIDPoint 405 Measurement Cartridge
Serial Numbers:2610900214 through 2621001325  Expiry Dates: Sept 13, 2016 through Dec. 6, 2016
Siemens RAPIDPoint 405 Measurement Cartridge   Siemens SMN numbers: 10844812, 1028322, 10313971 , 10310469
Serial Numbers:2610900214 through 2621001325.  Expiry Dates: Sept 13, 2016 through Dec. 6, 2016
Worldwide Distribution - US including CA, CT, GA, IL, NC, OR, SC, VA, WI, WY, and Internationally  to Australia, Azerbaijan, Brazil, Finland, France, Germany, Hungary, Italy, Luxembourg, Norway, Poland, Russia, Slovakia,  and Switzerland
Floor Mounting Column TS 7500 U, Material Number 1730732; Floor Mounting Column ARTIS, Material Number 1501878   Patient positioning during surgery, ranging from anesthesia induction to actual surgery to recover from the anesthesia. Also, patient transport on the operating table top from a patient transfer system to the operating theater of from the operating theater to a patient transfer system.
Three complaints describing TruSystem tables unexpectedly descending approximately 20 centimeters.
Stationary Column TruSystem 7599, Material Number 1717020    Patient positioning during surgery, ranging from anesthesia induction to actual surgery to recover from the anesthesia. Also, patient transport on the operating table top from a patient transfer system to the operating theater of from the operating theater to a patient transfer system.
Operating Table TruSystem 7000 U, Material Number 1604788; Operating Table TruSystgem 7000 U (MB), Material Number 1604786  Patient positioning during surgery, ranging from anesthesia induction to actual surgery to recover from the anesthesia. Also, patient transport on the operating table top from a patient transfer system to the operating theater of from the operating theater to a patient transfer system
Mobile Column TruSystem 7500, Material Number 1717023; Mobile Column TruSystem 5500, Material Number 1607822  Patient positioning during surgery, ranging from anesthesia induction to actual surgery to recover from the anesthesia. Also, patient transport on the operating table top from a patient transfer system to the operating theater of from the operating theater to a patient transfer system
Worldwide Distribution - USA (nationwide) Distribution.
Multix Fusion Stationary X-Ray System    Product Usage:  The Multix Fusion system is a radiographic system used in hospitals, clinics, and medical practices. Multix Fusion enables radiographic exposures of the whole body including: skull, chest, abdomen and extremities and may be used on pediatric, adult and bariatric patients. It can also be used for intravenous, small interventions (like biopsy, punctures, etc.) and emergency (trauma, critical ill)applications.
Siemens became aware of a potential issue with the patient table for Ysio Max and Multix Fusion systems.  There is an unlikely risk that an internal part of the table may detach causing the table top to tilt to the left side which could result in an injury to a patient on the table.
YSIO Max     Product Usage:  The Ysio Max is a radiographic system used in hospitals, clinics, and medical practices. Ysio Max enables radiographic and tomographic exposures of the whole body including: skull, chest, abdomen, and extremities and may be used on pediatric, adult and bariatric patients. It can also be used for intravenous, small interventions (like biopsy, punctures, etc.) and emergency (trauma, critical ill) applications. Exposures may be taken with the patient sitting, standing, or in the prone position. The Ysio Max system is not meant for mammography.
Multix Fusion VA10    Product Usage:  The Multix Fusion VA10 system is a radiographic system used in hospitals, clinics, and medical practices. Multix Fusion enables radiographic exposures of the whole body including:skull, chest, abdomen and extremities and may be used on pediatric, adult and bariatric patients. It can also be used for intravenous, small interventions (like biopsy, punctures, etc.) and emergency (trauma, critical ill)applications.
One consignee located in CA. No Canadian, other foreign or VA/govt/military consignees.
Merit Inflation Syringe Kit. Catalog Number KOS-02857
Merit Medical Systems, Inc. announces a voluntary field action for Merit Inflation Syring Kit due to unit labels missing required device labeling information.
Blood product, collected from a donor considered to be at increased risk for variant Creutzfeldt-Jakob Disease (vCJD), was distributed.
Blood Systems, Inc. dba United Blood Services Texas
Apheresis products for which white blood cell count testing was not performed, were distributed.
Blood product,s collected from a donor considered to be at increased risk for variant Creutzfeldt-Jakob Disease (vCJD), were distributed.
Blood product, in which quality control for WBC count was not performed, was distributed.
Blood product,s collected from a donor for whom donor suitability was not adequately determined, were distributed.
Blood product, in which donor suitability was not adequately determined, was distributed.
Blood Products collected from a donor who traveled to a malaria endemic area were distributed.
Apheresis Platelets, Platelet Additive Solution Added, Leukocytes Reduced
Worldwide Distribution - US Nationwide in the states of:: AK, AL, AR, AZ, CA, CO, CT, DE, GA, IA, IL, IN, FL, KS, KY, LA, MA, MD, ME, MI, MO, MS, MT, NC, ND, NE, NJ, NH, NM, NV, NY, OH, OK, OR, PA, RI, SC, TN, TX, UT, VA, VT, WA, WI, WV, & WY. and the countries of Algeria, Argentina, Australia, Bangladesh, Belgium, Bolivia, Brazil, Cambodia, China, COlumbia, Cuba, Denmark, Dijbouti, Dominican REpublic, Egypt, Estonia, Finland, France,  Germany, Gilbraltar, Greece, Hong Kong, Hungary, India, Indonesia, Iran, Ireland, Israel, Italy, Japan, Jordan, Kazakhstan, Korea, Latvia, Lebanon, Libya, Lithuania, Malaysia, Martinique, Monaco, Mongolia, Mozambique, Myanmar, Netherlands, New Zealand, Norway, Palestine, Panama, Peru, Philippines, Poland, Portugal, Qatar, Reunion, Russian Federation, Senegal, Singapore, Slovakia, South Africa, Spain,  Sweden, Seitzerland, Taiwan, Tanzania, Thailand, Tunisia, Turkey, Uniter Arab Emirates, United Kingdom, Uzbekistan, and Vietnam.
Ingenuity Core 128 Model Number 728323    Product Usage:  Computed Tomography X-ray systems intended to product cross-sectional images of the body by computer reconstruction of X-ray transmission data taken at different angles and planes.
The infant performance test did not meet the test specification for the Infant Head Uniformity test with High Resolution.  As a result, when the user performs High Resolution head scans, the reconstructed images may exhibit degraded image quality manifested as non-uniformity of the image, CT number shift greater than 5 Hounsfield units, and reduction in gray/white matter differentiation.  The issue is most sever in the High Resolution mode, and the factory reference pediatric scan protocols are set to High Resolution default.  Adults head scans have a factory reference protocol that defaults to standard resolution which doesn't experience the issue.
Ingenuity CT Model Number 728326    Product Usage:  Computed Tomography X-ray systems intended to product cross-sectional images of the body by computer reconstruction of X-ray transmission data taken at different angles and planes.
Ingenuity Core Model Number 728321  Product Usage:  Computed Tomography X-ray systems intended to product cross-sectional images of the body by computer reconstruction of X-ray transmission data taken at different angles and planes.
Brilliance 64 CT Model Number 728231    Product Usage:  Computed Tomography X-ray systems intended to product cross-sectional images of the body by computer reconstruction of X-ray transmission data taken at different angles and planes.
Vyvanse (lisdexamfetamine dimesylate) Capsules 30 mg, 100 count bottle, Rx Only, Manufactured for: Shire US, Inc., Lexington, MA 02421, NDC 59417-103-10
RayStation 2.5, 3.0, 3.5, 4.0, 4.5, 4.7, 5.0 and 4.3 (InverseArc 1.0) -- Radiation Therapy Treatment Planning System  RayStation is a software system designed for treatment planning and analysis of radiation therapy. The treatment plans provide treatment unit set-up parameters and estimates of dose distributions expected during the proposed treatment, and may be used to administer treatments after review and approval by the intended user. The system functionality can be configured based on user needs.
RaySearch became aware of the problem as it was discovered in cooperation with a customer experimenting with the dose calculation on a phantom. The correction concerns two issues found with the dose calculation when using a region of interest (ROI) of type Fixation or Support with material override within the patient outline (External ROI) in RayStation 2.5, 3.0, 3.5, 4.0, 4.5, 4.7, 5.0 and 4.3 (InverseArc 1.0).
buPROPion Hydrochloride Extended-release Tablets, USP (SR), 150 mg, Twice-A-Day, in 60 count bottles, Rx only, Distributed by: Sun Pharmaceutical Industries, Inc. Cranbury, NJ 08512 Manufactured by Sun Pharmaceuticals Ind. Ltd. Halol- Baroda Highway, Halol-389 350, Gujarat, India. UPC 347335737868  NDC 47335-737-86
According to the firm, the IgE Calibrator Series IE2492 (lot 387-392IE) value assignment has now been aligned to the 3rd International Standard for human serum IgE 11/234.    Turbidimetric (Non-IFCC Cal.) Quality Control Targets and Ranges now apply. The calibrator value sheet is to be updated with the new values.
Catalogue number    IE2492    Batch number    354213, 386994
Phenotolamine 0.4mg/Prostaglandin 20mcg/mL packaged in 2.5 mL sterile vials, IM, Rx, The Apothecary Shoppe, Jenks, OK
Lack of Assurance of Sterility; medication was sterilized with a recalled filter
Methylcobalamin 5000 mcg/mL Injection, packaged in 1, 2, 3, 4, and 5 mL vials, IM, Rx, The Apothecary Shoppe Compounding Pharmacy, Jenks, OK
Tri-Mix 18/1/10 (Papaverine 18mg, Phentolamine 1 mg, Prostaglandin 10 mcg/mL) packaged in 2.5 mL sterile vials, IM, Rx, The Apothecary Shoppe, Jenks, OK
Worldwide Distribution -- US, to the states of TN and MS; and the country of Canada.
MicroStic Plus w/SS Wire 5F and MicroStic Plus w/NiTi Wire & Echo Needle 4F.    A sheath used to facilitate placing a catheter through the skin into a vein or artery.
The supplier initiated a recall because affected lots of the micro-introducer have an outer diameter of the dilator hub that is slightly smaller than is capable of securing the dilator to the sheath
Worldwide Distribution - US Distribution to the states of :  VA, UT, TX. OR, MN, AL, PA, CA and KY.,  and to the countries of : AUSTRALIA, China, Italy, Netherlands and Japan.
Vanguard 360 Revision Knee System  Knee prostheses
The drill bit used to drill the hex pre-drilled hole in the screw head of the Tibial Augment Bolts included in the Vanguard 360 Revision Knee System was larger than allowable per the process specification.  As a result, the hex geometry can still be visible, but there are radial cuts into the hex flat. Therefore, when the bolt is inserted into the augment, the screwdriver is unable to catch on the hex geometry, or the screwdriver strips the remaining hex geometry, and the bolt is unable to be fully tightened.    The bolt stripping or the bolt not being fully tightened will be noticed by the surgeon intraoperatively when he or she is unable to screw the augment bolts into the augment. This possible event can result in an intraoperative delay resulting in increased time under anesthesia.
PredniSONE Tablets USP, 1 mg, 100-count bottles, Rx only, Distr. by: West-Ward Pharmaceuticals Corp., Eatontown, NJ  07724, NDC 0054-4741-25.
Failed Tablet/Capsule Specifications: Discovery of an underweight tablet.
Human corneas, not tested adequately and appropriately to reduce the risk of transmission of relevant communicable diseases, were distributed.
Softbank Blood Bank Software, with a defect or glitch, was distributed.
Blood products, collected from an ineligible donor, were distributed.