Product was distributed in IA and IL.  No foreign, military, or federal goverment distribution.
Heartland Products, Inc. Roma's Italian Base, 120116, packaged in 50-lb. poly-lined cardboard boxes, Manufactured by Heartland Products, Inc., Des Moines, IA.
Presence of high levels of Azodicarbonamide (ADA), failure to declare allergens on label, and potential cross-contamination with allergens.
ILL RIVER Sweet Dough Base, 050107, packaged in 50-lb. poly-lined cardboard boxes, Distributed by T.S. Products, Inc.
Dough base/premix packaged in 30-lb. poly-lined cardboard boxes, manufactured under the following labels:    (1) Heartland Products, Inc. Fancy Breads Italian Base, 090108.   Manufactured by Heartland Products, Inc., Des Moines, IA; and    (2) Northern Lights Pizza, 090108, Manufactured by Heartland Products, Inc., Des Moines, IA.
Turano Knead Dough Base, 70101, packaged in 42-lb. poly-lined cardboard boxes, Manufactured for Turano Baking Co., Bolingbrook, IL.
ILL RIVER #14 Bread Base, 050102, packaged in 28-lb. poly-lined cardboard boxes, Distributed by T.S. Products, Inc.
Waveland Pancake and Waffle Mix, 030608, packaged in 25-lb. poly-lined cardboard boxes, Manufactured Heartland Products, Inc. Des Moines, IA 50321.
No lot number given; date of manufacture was 6/4/2015
C. H. Guenther & Son, Inc.dba Morrison Milling
Morrison's Pancake Mix Complete Net Wt 5 LB (2.27 kg)
May contain small metal fragments from wire mesh sifter.
Morrison's Country Style Corn Bread Mix NET WT 25 LB (11.33 kg) and Morrison's Country Style Cornbread Mix NET WT 5 LB (2.27 kg)
Morrison's Texas Style Mexican Cornbread Mix NET WT 6 OZ (170g) packed in paper box
Parade Cornbread Mix Yellow NET WT/PESO NETO 6 OZ (170g) packed in paper box
Cotton Patch Cafe Sweet Corn Muffin Mix 93381 NET WT. 6 LBS. (2.72 kg)
Pioneer Corn Bread Mix NET WT 5 LBS (2.27 kg)
Fiesta Yellow Cornbread Mix NET WT 6 OZ (170g) packed in paper box
Morrison's Premium White Corn Meal Enriched NET WT 5 LB (2.27 kg); Morrison's Premium White Corn Meal Self-Rising Mix Enriched NET WT 5 LB (2.27 kg); Hill Country Fare Enriched White Cornmeal NET WT. 32 OZ (2 LBS); Great Value Self-Rising White Corn Meal Mix Enriched NET WT 5 LB (2.27 kg); Pioneer Enriched White Corn Meal NET WT 5 LB (2.27 kg); Pioneer Enriched White Corn Meal NET WT 2 LB (0.90 kg) - all products packaged in paper bags; Morrison's Premium White Corn Meal NET WT 25 lb (11.34 kg); Premium White Cornmeal Enriched NET WT 25 LB (11.34 kg); Pioneer Enriched White Corn Meal NET WT 25 LB (11.343 kg)
HEB Cheddar Bacon Flavored Cornbread Mix NET WT. 13.3 OZ (377g) packed in paper box
Ben E. Keith Keith's Premium Deluxe Buttermilk Pancake Mix NET WT 5 lb (2.27 kg)
Buttermilk Pancake Mix # 1 NET WT 5 LBS (2.27kg)
Morrison's Premium Yellow Corn Flour NET WT 25 LB (11.33 kg)
Pioneer Buttermilk Pancake Mix NET WT 5 LBS (2.27 kg)
Morrison's Texas Style White Cornbread Mix NET WT 6 OZ (170g) packed in paper box
HEB Rosemary Olive Oil with Sea Salt Cornbread Mix NET WT. 13.3 OZ (377g) packed in paper box
Razzoo's Seasoned Corn Flour NET WT 25 LB (11.33 kg)
Cotton Patch Cafe Chicken Fried Steak Batter Mix NET WT 30 LBS (13.63 kg)
American Blue Ribbon Holdings. LLC Multigrain Pancake Mix NET WT 37.5 LBS (17.01 kg)
Morrison's Texas Style Honey Sweet Cornbread Mix NET WT 6 OZ (170g) packed in paper box
HEB Maple Bacon Flavored Cornbread Mix NET WT. 13.3 OZ (377g) packed in paper box
Champs Chicken Southern Style Fish Breading Net Wt. 25 lbs. (11.33 Kg)
Conestoga Buttermilk Pancake Mix NET WT. 5 LB. (2.27 kg)
Darden Super Breader XL NET WEIGHT 25 LB (11.34 kg)
On The Border Mexican Grill & Cantina Tempura Batter Net Wt 25 LBS (11.34 kg)
Parade Enriched All-Purpose Corn Meal Yellow NET WT/PESO NETO 5 LB (2.27 kg); Parade Enriched All-Purpose Corn Meal Yellow NET WT/PESO NETO 32 OZ (2 LB); Hill Country Fare Enriched Yellow Cornmeal NET WT 5 LBS CONT. NET. 2.3 kg; Hill Country Fare Enriched Yellow Cornmeal NET WT 32 OZ (2 LBS); Morrison's Premium Yellow Corn Meal Self-Rising Mix Enriched NET WT 5 LB (2.27 kg); Morrison's Premium Yellow Corn Meal Enriched NET WT 5 LB (2.27 kg) - all packaged in paper bags; Luby's Yellow Corn Meal NET WT 25 LB (11.34 kg); Morrison's Peacemaker Yellow Corn Meal Enriched NET WT 25 LB (11.34 KG); Morrison's Premium Yellow Degermed Corn Meal NET WT 25 LB (11.34 kg); Ben E. Keith Keith's Exclusive Premium Yellow Corn Meal NET WT 25 LB (11.34 kg); Morrison's Premium Yellow Corn Meal NET WT 25 LB (11.33 kg)
HEB Lemon Seasonal Fish Fry Mix NET WT. 16 OZ (1 LB) CONT. NET 454g and HEB Lemon Seasonal Fish Fry Mix NET WT. 10 OZ  CONT. NET 284g  packed in paper box
HEB Original Seasonal Fish Fry Mix NET WT. 16 OZ (1 LB) CONT. NET 454g and HEB Original Seasonal Fish Fry Mix NET WT. 10 OZ  CONT. NET 284g  packed in paper box
Morrison's Coarse Ground Yellow Cornbread Mix NET WT 6 OZ (170g) packed in paper box
HEB Sweet & Spicy Cornbread Mix NET WT. 13.3 OZ (377g) packed in paper box
Z Tejas Cornbread Blend 212759 NET WEIGHT 4.5 LBS. (2.04 kg)
CFS Batter/Breader Mix Net Weight 5 Lbs (2.27 KG)
Pioneer Brand Maple Flavor Pancake & Waffle Complete Mix Premium Quality NET WT 6 oz. (170g) packed in paper box
Morrison's Pancake Mix Net Wt 5 LB (2.27 kg)
Morrison's Corn Kits Prepares Cornbread Mix NET WT 6 OZ (170g) packed in paper box
Original Tempura Batter Mix Net Weight 5 Lbs (2.27 KG)
Golden Chicken Batter Mix Net Wt. 27 LBS (12.25 kg)
Ben E. Keith Cornbread Mix NET WT 5 lb. (2.27kg)
Marie Callender's Low Fat Southwestern Corn Bread Mix NET WT 1 lb (16 oz. ) 454 grams
Hartz Krispy Chicken 'N' Rolls Milk Dip Net Wt 20 LBS (9.07 kg)
Marie Callender's Low Fat Original Corn Bread Mix NET WT 1 lb (16 oz. ) 454 grams
Ben E. Keith Keith's Exclusive Complete Pancake Mix NET WT 5 lb (2.27 kg)
Parade Cornbread Mix White NET WT/PESO NETO 6 OZ (170g) packed in paper box
Superior by Farmer Brothers Buttermilk Pancake Mix NET WT 5 LB (2.27 kg)
Deluxe Buttermilk Pancake Mix NET WT 25 LB (11.33 kg)
Conestoga Buttermilk Pancake & Waffle Mix NET WT 25 LB (11.34 kg)
Pioneer Original Buttermilk Pancake Mix NET WT 5 LBS 2.27 kg
Morrison's Hushpuppy Mix NET WT 5 LB (2.27 kg)
Pioneer Original Buttermilk Pancake & Waffle Mix NET WT 5 LBS 2.27 kg and Pioneer Original Buttermilk Pancake & Waffle Mix NET WT 25 LBS 11.34 kg
Cotton Patch Cafe Catfish Breader 212562 Net Wt. 25 LBS (11.34 kg)
HEB Seasonal Shrimp & Oyster Fry Mix NET WT. 10 OZ CONT. NET 284g packed in paper box
Chicken Express Batter Mix 93455 Net Wt. 25 LBS (11.34 kg)
Morrison's Country Style Buttermilk Pancake Mix Net Wt 5 LB (2.27 kg)
Pioneer Sweet Potato Pancake Mix NET WT/PESO NETO 5 LBS (2.27 kg)
Pioneer Hush Puppy Mix  NET WT 5 LB 2.27 kg
Braum's Hot Cake Mix NET WT 32 oz (907 g)
HEB Original Seasonal Catfish Fry Mix NET WT. 10 OZ  CONT. NET 284g  packed in paper box
Champs Chicken Batter Mix Net Wt. 25 lbs. (11.33 Kg)
Authentic Creations Multigrain Pancake Mix NET WT 37.5 LBS (17.01 kg)
Pioneer Brand Original Buttermilk Pancake and Waffle Mix Premium Quality NET WT 32 oz. (2 lb) 907g packed in paper box
Pioneer Sweet Corn Muffin Mix NET WT. 5 LBS 2.27 kg
Chubby's Foods Cornbread Mix 6/5 LB 7816
Ben E. Keith Home Style Cornbread Mix NET WT 5 lb. (2.27kg)
Braum's Pancake & Waffle Mix NET WT 24 LBS (10.90kg)
Pioneer Mulit-Grain Pancake & Waffle Mix NET WT 5 LBS (2.27 kg)
HEB Fish Coating Mix Mango Habanero NET WT. 12 OZ (340g) packed in paper box
Bill Miller BBQ Batter Mix NET WT 48 OZ (3 LB) (1.36 kg)
Marie Callender's Low Fat Honey Butter Corn Bread and Muffin Mix NET WT 1 lb (16 oz. ) 454 grams
HSRG Cornmeal Breader NET WT 25 LB (11.33 kg)
Morrison's Home Style Cornbread Mix NET WT 5 LB (2.27 kg)
Pioneer Brand Complete Buttermilk Pancake & Waffle Mix Premium Quality NET WT 32 oz. 2 lb/907g and Pioneer Brand Buttermilk Pancake & Waffle Complete Mix Premium Quality NET WT 6 oz (170g) packed in paper box
Delgado Relleno Batter Mix Net Wt 1 lb. (453 kg)
Fletcher's Corny Dog Mix NET WT 25 LB (11.33 kg)
Morrison's Premuim Self-Rising Cornmeal Mix NET WT 25 LB (11.33 kg)
Morrison's Texas Style Yellow Cornbread Mix NET WT 6 OZ (170g) packed in paper box
HEB Fish Coating Mix Black Pepper Parmesan NET WT. 12 OZ (340g) packed in paper box
Krispy Krunchy Chicken Fish Fry Net Weight 5 Lbs. (2.27kg)
Razzoo's Hushpuppy Mix NET WT 5 LBS (2.27 kg)
Pioneer Brand No Fat Complete Buttermilk Pancake & Waffle Mix Premium Quality NET WT 32 oz. (2 lb) 907g packed in paper box
Morrison's Cornbread Mix NET WT 5 LB (2.27 kg)
Three US Customers and One customer in Holland. Second lot bonded and tested in Switzerland but final destination was same customer in Holland. Additional customer in United Kingdom.
Chuka Ika Sansai ECO - International name and Natural Chuka Ika Sansai for US (Seasoned Squid Salad);  Net Wt.: 4.4 lbs. (2 kg) for US customer:  2.2 lbs. (1 kg) for European customer.    Second lot:  Net Wt. 2.2 lbs (8 pkg/1 kg) for European customer  4.4.lbs (2 kg)    Shelf life is 24 months for US, 18 months for EU customer per request.    Perishable/Keep frozen Until Use;  Thaw under refrigeration immediately before use.    Ingredients: Squid (Peru. Wild), Yamakurage (lettuce stem) Kikurage Mushroom, Bamboo Shoot, Seasoned Ginger (ginger, water, cane sugar, salt, distilled white vinegar, citric acid), Sesame Seed, Sugar, Natural Vinegar, White Soy Sauce (water, salt, soybeans, wheat), Sweet Rice Wine, Natural Rice Wine, Sesame Oil, Sorbitol (2 g per 100g serving) Salt, Kelp Extract, Bonito Extract, Red Pepper, Dextrose, Yeast Extract, Xanthan Gum, Annatto, Sodium Phosphate.  Allergen Information: Contains Squid, Fish Extract (Bonito) Sesame See, Soy, Wheat.    Manufactured by: Azuma Foods International Inc., U.S.A.  Hayward, CA 94545  Processed in the U.S. A.
138 cases lot 25-1429 and 124 cases of lot 26-0937: Additional 1179 cases for final recall expansion.
Firm was notified by EU of a positive sample for Listeria Monocytogenes in Squid Salad tested by their customer in the Netherlands. A second customer reported an additional positive finding and an additional lot of Squid Salad was also recalled.
Gutierrez Distributor, (a) Tarugo con chile spicy tamarind, 349 Chestnut Street, Passaic, NJ 07055 UPC 8527050000904    (b) Dulce de pulpa 100% de Tamarindo, Betamex, Alamos No.7 STA. Maria Aztahuacan Deleg. Iztapalapa C.P. 09500 Mexico, D.F.
(a) 240 bags (5 pieces per bag) (b) 37 boxes (40 pounds/box)
Distribution US nationwide and Pakistan.
Medix NatalCare ST-LX Intensive Care Incubator.  Neonatal incubator.
75 units (65 units in the US and 10 units in Pakistan)
NatalCare LX Incubators were manufactured using a defective oval port hinge assembly with the result that the screws holding the port in place can become loose and possibly result in the port detaching from the incubator.
Distributed US (nationwide) and the countries of Canada and Australia.
BARDEX I.C. Anti-Infective 2-Way 3cc Foley Catheter, Rx only.  Intended for urinary bladder drainage in female patients requiring catheterization for management of incontinence, voiding dysfunction and surgical procedure.
Labeling error: Catalog contains Instructions for Use (IFU) error; incorrect inflation volume.
Catalog numbers: 0165I108 and 065SI10; All lot numbers produced with IFU (PK7634040) are affected.
BARDEX I.C. Anti-Infective 2-Way 5cc Foley Catheter. Intended for urinary bladder drainage in female patients requiring catheterization for management of incontinence, voiding dysfunction and surgical procedure.
BARDEX I.C. Anti-Infective 2-Way Red Latex Foley Catheter, 5cc (Council Model);  Intended for urinary bladder drainage in female patients requiring catheterization for management of incontinence, voiding dysfunction and surgical procedure.
CodeCatalog numbers: 0146SI16, 0146SI18, 0146SI20 and 0146SI22. All lot numbers produced with IFU (PK7634040) are affected.
Uoriki Octopus Salad Net Weight 2.5 lbs         Two 2.5lbs pack per case  packaged in Black trays covered w/cryovac 10k film  no barcode. packaged at Wegman's deli counter for further consumption.
Octopus Salad may be contaminated with Listeria monocytogenes.
Catalog Number:  9002123  KNEE ARTHROSCOPY SURGICAL PACK   Used by medical staff to perform surgical procedures and  patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
Recall initiated due to inadequate validation/qualification of sterilization processes, and package integrity for products released for distribution as sterile.
Catalog Number:  9003190  SURG GOWN SMS AMMI IV FULL  Used by medical staff to perform surgical procedures and  patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
Catalog Number:  9002618  OPEN HEART SURGICAL PACK   Used by medical staff to perform surgical procedures and  patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
Catalog Number:  9002829  BASIC  SURG PACK  Used by medical staff to perform surgical procedures and  patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
Catalog Number:  9001765  MINOR LACERATION TRAY  Used by medical staff to perform surgical procedures and  patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
Catalog Number:  900176  LAPAROTOMY SURGICAL PACK  Used by medical staff to perform surgical procedures and  patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
Catalog Number:  900063 WOUND CLOSURE TRAY I  Used by medical staff to perform surgical procedures and  patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
Catalog Number:  900169  UNIVERSAL SURGICAL PACK   Used by medical staff to perform surgical procedures and  patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
Catalog Number:  9002164  FEMORAL SURGICAL PACK  Used by medical staff to perform surgical procedures and  patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
Catalog Number:  9002193  SHOULDER ARTHROSCOPY SURGICAL PACK  Used by medical staff to perform surgical procedures and  patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
Catalog Number:  9002224  SURGICAL PACK   Used by medical staff to perform surgical procedures and  patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
Catalog Number:  900010 SUTURE REMOVAL KIT  Used by medical staff to perform surgical procedures and  patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
Catalog Number:  900982  ARTHROSCOPY SURGICAL PACK  Used by medical staff to perform surgical procedures and  patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
Catalog Number:  9002899  CYSTO TUR SURGICAL PACK   Used by medical staff to perform surgical procedures and  patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
Catalog Number:  9002469  BASIC  SURGICAL PACK IV  Used by medical staff to perform surgical procedures and  patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
Catalog Number:  900419  LABOR & DELIVERY SURGICAL PACK   Used by medical staff to perform surgical procedures and  patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
Catalog Number:  900278  URETHRAL CATHETER TRAY  14FR  Used by medical staff to perform surgical procedures and  patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
Catalog Number:  9002259A  LAPAROSCOPY-COLORECTAL SURGICAL PACK  Used by medical staff to perform surgical procedures and  patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
Catalog Number:  9002609  ARTHOSCOPY PACK   Used by medical staff to perform surgical procedures and  patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
Catalog Number:  9001154 WOUND MANAGEMENT TRAY  Used by medical staff to perform surgical procedures and  patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
Catalog Number:  9001198 WOUND MANAGE II   Used by medical staff to perform surgical procedures and  patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
Catalog Number:  900522  SURGICAL GOWN SMS POLY-REINFORCED, RAGLAN SLEEVE, AAMI LEVEL III, LARGE  Used by medical staff to perform surgical procedures and  patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
Catalog Number:  900547  BASIC SURGICAL PACK   Used by medical staff to perform surgical procedures and  patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
Catalog Number:  9002726  HIP AND KNEE REPLACEMENT SURGICAL PACK   Used by medical staff to perform surgical procedures and  patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
Catalog Number:  900521  SURGICAL GOWN SMS POLY-REINFORCED, RAGLAN SLEEVE, AAMI LEVEL III, X-LARGE  Used by medical staff to perform surgical procedures and  patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
Catalog Number:  900410  CESAREAN SECTION SURGICAL PACK  Used by medical staff to perform surgical procedures and  patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
Catalog Number:  9001780  OPHTHALMIC SURGICAL PACK   Used by medical staff to perform surgical procedures and  patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
Catalog Number:  9001127 FOLEY CATHETER TRAY 16 FR-5CC- 2WAY SILICONE COATED FOLEY  Used by medical staff to perform surgical procedures and  patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
Catalog Number:  900774  INCISION AND DRAINAGE TRAY  Used by medical staff to perform surgical procedures and  patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
Catalog Number:  900020 IRRIGATION TRAY WITH IRRIGATION BULB SYRINGE  Used by medical staff to perform surgical procedures and  patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
Catalog Number:  9001062 ARTHROSCOPY SURGICAL PACK   Used by medical staff to perform surgical procedures and  patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
Catalog Number:  900540  WOUND MANAGEMENT TRAY III  Used by medical staff to perform surgical procedures and  patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
Catalog Number:  9001460  REYITO PLUS UROLOGY SURGICAL PACK   Used by medical staff to perform surgical procedures and  patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
Catalog Number:  900032 UNIVERSAL DRAINAGE TRAY  Used by medical staff to perform surgical procedures and  patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
Catalog Number:  9001496  D&C LAPAROSCOPY SURGICAL PACK  Used by medical staff to perform surgical procedures and  patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
Catalog Number:  9001771  MAYO STAND COVER STERILE  Used by medical staff to perform surgical procedures and  patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
Catalog Number:  9001139 FOLEY CATHETER TRAY 18 FR -5CC-2WAY SILICONE COATED FOLEY  Used by medical staff to perform surgical procedures and  patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
Catalog Number:  900450  LAPAROTOMY SURGICAL PACK   Used by medical staff to perform surgical procedures and  patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
Catalog Number:  9001402  PLASTIC SURGERY PACK  Used by medical staff to perform surgical procedures and  patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
Catalog Number:  9002940  OBSTETRICAL SURGICAL PACK  Used by medical staff to perform surgical procedures and  patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
Catalog Number:  9002615  EXTREMITY SURGICAL PACK  Used by medical staff to perform surgical procedures and  patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
CUFF  Used by medical staff to perform surgical procedures and  patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
Catalog Number:  9001297  PREMIUM OBSTETRICAL SURGICAL PACK  Used by medical staff to perform surgical procedures and  patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
Catalog Number:  9001456  WOUND MANAGEMENT TRAY  Used by medical staff to perform surgical procedures and  patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
Catalog Number:  900576A  LAP-CHOLECYSTECTOMY SURGICAL PACK   Used by medical staff to perform surgical procedures and  patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
Catalog Number:  9001738  UROLOGY SURGICAL PACK   Used by medical staff to perform surgical procedures and  patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
Catalog Number:  9001300  NEURO-SPINE SURGICAL PACK   Used by medical staff to perform surgical procedures and  patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
Catalog Number:  900742A  CARPAL TUNEL LARGE SURGICAL PACK  Used by medical staff to perform surgical procedures and  patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
Catalog Number:  900080 CYSTOSCOPY SURGICAL PACK  Used by medical staff to perform surgical procedures and  patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
Catalog Number:  9002167  LITHOTOMY SURGICAL PACK   Used by medical staff to perform surgical procedures and  patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
Catalog Number:  9001091 PERY-GYN SURGICAL PACK  Used by medical staff to perform surgical procedures and  patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
Catalog Number:  900582  UTILITY DRAPE WITH TAPE, SMS  Used by medical staff to perform surgical procedures and  patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
Catalog Number:  9001202 LAMINECTOMY PK   Used by medical staff to perform surgical procedures and  patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
Catalog Number:  900548A  PERY-GYN SURGICAL PACK  Used by medical staff to perform surgical procedures and  patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
Catalog Number:  9001061 PERI-GYN SURGICAL PACK  Used by medical staff to perform surgical procedures and  patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
Catalog Number:  900944  CATARACT SURGICAL PACK   Used by medical staff to perform surgical procedures and  patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
Catalog Number:  9002614  HIP AND KNEE REPLACEMENT SURGICAL PACK  Used by medical staff to perform surgical procedures and  patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
Catalog Number:  900484  LAPAROSCOPIC GYNECOLOGY SURGICAL PACK   Used by medical staff to perform surgical procedures and  patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
Catalog Number:  900403  CESAREAN SECTION SURGICAL PACK   Used by medical staff to perform surgical procedures and  patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
Catalog Number:  900782  SKIN STAPLE REMOVER STERILE  Used by medical staff to perform surgical procedures and  patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
Catalog Number:  9002256  NEUROSURGERY PACK   Used by medical staff to perform surgical procedures and  patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
Catalog Number:  900997  PERI-GYN SURGICAL PACK   Used by medical staff to perform surgical procedures and  patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
Catalog Number:  900946  STRABISMUS SURGICAL PACK  Used by medical staff to perform surgical procedures and  patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
Catalog Number:  900110 TRACHEOSTOMY CARE KIT WITH TRACH TUBE HOLDER FOR ADULT  Used by medical staff to perform surgical procedures and  patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
Catalog Number:  900012 OB SURGICAL PACK   Used by medical staff to perform surgical procedures and  patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
Catalog Number:  900036 LAPAROTOMY SURGICAL PACK   Used by medical staff to perform surgical procedures and  patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
Catalog Number:  900486  LAPAROSCOPY SURGICAL PACK   Used by medical staff to perform surgical procedures and  patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
Catalog Number:  900168  LABOR & DELIVERY SURGICAL PACK   Used by medical staff to perform surgical procedures and  patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
Catalog Number:  9001538  DRESSING CHANGE TRAY  Used by medical staff to perform surgical procedures and  patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
Catalog Number:  900629  STERILE OR CLOTH TOWEL BLUE  Used by medical staff to perform surgical procedures and  patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
Catalog Number:  900740A  ARTHROSCOPY SURGICAL PACK  Used by medical staff to perform surgical procedures and  patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
Catalog Number:  9002511  MINOR SURGICAL PACK   Used by medical staff to perform surgical procedures and  patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
Catalog Number:  9001294  PREMIUM CESAREAN PACK  Used by medical staff to perform surgical procedures and  patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
Catalog Number:  900474  LAPAROSCOPY SURGICAL PACK  Used by medical staff to perform surgical procedures and  patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
Catalog Number:  900921A  C-SECTION SURGICAL PACK  Used by medical staff to perform surgical procedures and  patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
Catalog Number:  900345  BASIC SURGICAL PACK  Used by medical staff to perform surgical procedures and  patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
Catalog Number:  900998  CESAREAN SECTION SURGICAL PACK   Used by medical staff to perform surgical procedures and  patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
Catalog Number:  9002510  UROLOGY SURGICAL PACK   Used by medical staff to perform surgical procedures and  patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
Catalog Number:  900796  FEMORAL ANGIOGRAPHY SURGICAL PACK   Used by medical staff to perform surgical procedures and  patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
Catalog Number:  900996  LAPAROTOMY SURGICAL PACK   Used by medical staff to perform surgical procedures and  patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
Catalog Number:  900633  FAN FOLD SHEET 44 X 58  Used by medical staff to perform surgical procedures and  patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
Catalog Number:  9002830  ORTHOPEDIC SURGICAL PACK  Used by medical staff to perform surgical procedures and  patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
Catalog Number:  900064 WOUND CLOSURE TRAY II  Used by medical staff to perform surgical procedures and  patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
Catalog Number:  900618A  LAPAROSCOPY-GYN SURGICAL PACK  Used by medical staff to perform surgical procedures and  patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
Catalog Number:  900277  SUCTION CATHETER TRAY 14FR WITH SODIUM CHLORIDE 0.9% IRRIGATION  Used by medical staff to perform surgical procedures and  patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
Catalog Number:  900281A  LAPAROTOMY PACK  Used by medical staff to perform surgical procedures and  patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
Catalog Number:  900028 LAPAROSCOPY SURGICAL PACK
Catalog Number:  9001771 MAYO STAND COVER STERILE  Used by medical staff to perform surgical procedures and  patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
Catalog Number:  9001298  PREMIUM ARTHROSCOPY PACK  Used by medical staff to perform surgical procedures and  patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
Catalog Number:  900741A  ORTHO-IMPLANT SURGICAL PACK  Used by medical staff to perform surgical procedures and  patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
Catalog Number:  9002766  SHOULDER PACK  Used by medical staff to perform surgical procedures and  patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
Catalog Number:  9001296  PREMIUM LAPAROTOMY PACK  Used by medical staff to perform surgical procedures and  patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
Catalog Number:  9001482  ENT SURGICAL PACK   Used by medical staff to perform surgical procedures and  patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
Catalog Number:  9001966  LIVER & PANCREAS SURGERY   Used by medical staff to perform surgical procedures and  patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
Catalog Number:  900164  FEMORAL SURGICAL PACK    Used by medical staff to perform surgical procedures and  patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
Catalog Number:  9001933  OPHTALMIC SURGICAL PACK   Used by medical staff to perform surgical procedures and  patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
Catalog Number:  9001521  UROLOGY SURGICAL PACK   Used by medical staff to perform surgical procedures and  patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
Catalog Number:  900052 MINOR PROCEDURE SURGICAL PACK   Used by medical staff to perform surgical procedures and  patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
Catalog Number:  9001408  UMBILICAL VESSEL CATHETER KIT   Used by medical staff to perform surgical procedures and  patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
Catalog Number:  9002516  LAPAROTOMY SURGICAL PACK   Used by medical staff to perform surgical procedures and  patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
US Consignees; 222 units distributed in the following states: AL, AR, AZ, CA, CO, CT, FL, GA, HI, IA, IL, IN, KY, LA, MA, MD, MI, MO, MS, NC, NE, NJ, NV, NY, OH, OK, OR, PA, SC, SD, TN, TX, VA, WA, WI and WV.  ***Foreign Consignees; 1374 units distributed in the following countries:  Australia, Austria, Belgium, Bosnia & Hercegovina, Brazil, CANADA, China, Czech Republic, Denmark, Finland, France, Germany, Hong Kong, Hungary, Iceland, Ireland, Italy, Japan, Lithuania, Luxemburg, Netherlands, New Zealand, Nigeria, Norway, Poland, Portugal, Saudi Arabia, Singapore, Slovenia, South Africa, Spain, Sweden, Switzerland, Taiwan and  UK.
The Concerto Basic Shower Trolley is intended for assisted hygiene care, especially showering and bathing of residents in care environments such as senior/assisted living, group home, special care, nursing homes, hospitals and home care. The Concerto Basic Shower Trolley is intended for indoor use.
Reports of the bolts connecting the stretcher to the hydraulic piston and the stretcher tilting mechanism becoming loose.
All Concerto & Basic Shower Trolleys manufactured by ArjoHuntleigh Polska Sp. z o.o, March 7, 2014 through April 20, 2015 with serial numbers from P0227559 - P0322393
Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Ohio, Michigan, Indiana, Maryland, New York, Illinois, Texas, Florida, Wisconsin, Minnesota, Georgia, Pennsylvania, Utah, California, Oregon, New Jersey, Tennessee
MATLAW'S INDIVIDUALLY QUICK FROZEN FROZEN SHRIMP Farm Raised Product of: Vietnam Distributed by: National Fish & Seafood Inc., Gloucester, MA 01930 U.S.A 10 X 2 LB (0.907 Kg) Bags Net WT 20 LB (9.07 Kg).    Catalog Number: :  MLBG76006880  UPC Code: 0 41625 12012 4
Lot Numbers: 20860R 20001Q:   Best By 02 23 17 Production Code 26021023515;  Best By 02 26 17 Production Code 26021023815;  Best By 02 25 17 Production Code 26021023715;  Best By 02 27 17 Product.ion Code 26021023915;  Best By 02 28 17 Production Code 26021024015;  Best By 02 24 17 production Code 26021023615
US Distribution to the states of :  AR, CA, FL, LA, MO, MI, MS, NY, TN, and TX.
rapid exchange (RX) Peripheral Dilatation Catheter.  Distributed by US Endovascular, St. Louis, MO.
Product may kink during use rendering the product unusable.
Ingenuity Core 128 Computed Tomography X-ray Systems,  Intended to produce cross-sectional images of the body by computer reconstruction of X-ray transmission data taken at different angles and planes
The firm was notified of a software error in which the system may not automatically send all image/data series to remote devices.
Brilliance iCT Computed Tomography X-ray Systems,  Intended to produce cross-sectional images of the body by computer reconstruction of X-ray transmission data taken at different angles and planes
Ingenuity CT Computed Tomography X-ray Systems,  Intended to produce cross-sectional images of the body by computer reconstruction of X-ray transmission data taken at different angles and planes
Brilliance 64:Computed Tomography X-ray Systems,  Intended to produce cross-sectional images of the body by computer reconstruction of X-ray transmission data taken at different angles and planes
Brilliance iCT SP Computed Tomography X-ray Systems,  Intended to produce cross-sectional images of the body by computer reconstruction of X-ray transmission data taken at different angles and planes
Ingenuity Core Computed Tomography X-ray Systems,    Intended to produce cross-sectional images of the body by computer reconstruction of X-ray transmission data taken at different angles and planes
Distributed in the states of AZ, CA, DE, IN, MI, NM, PA & VA.
The firm received complaints that the product is shorter in length than indicated on the label.
Figi's Classic Marzipan, item 100-0034-200, 8 ounce
because the ingredients are not properly labeled and the product contains almonds.
Product labeled Chicken Salad Croissant sandwiches were made using Albacore Tuna Salad filling, therefore containing undeclared fish.
GE Healthcare has recently become aware of a potential safety issue involving a momentary, self-correcting anesthetic agent bolus when using 21% oxygen on all Aisys CS2 and upgraded Aisys anesthesia devices.
Rotaflow Centrifugal Pump    Custom tubing packs for the oxygenator
Maquet Cardiopulmonary (MCP) is conducting a voluntary recall based on the potential risk of exposure to endotoxin for various products.
BEQ-RF32, BEQ-RF-32-USA, BO-RF-32, BO-RF-32 USA, RF-32, RF-32 USA, RF-32u.
QUADROX-i oxygenators     Custom tubing packs for the oxygenator
All sizes and membrane types of QUADROX-i oxygenators, QUADROX-i(D) Adult, Small Adult, Pediatric and Neonatal with SOFTLINE and BIOLINE Coating; BE-HMOD xxxxx, BEQ-HMO xxxxx,  BEQ-HMOD xxxxx, BO-VKMO xxxxx, HMO xxxxx, HMOD xxxxx, VKMO xxxxx, X HMO xxxxx U,  X HMOD 30000 U, X VKMO xxxxx U, and X 1895. QUADROX-iR with SOFTLINE and BIOLINE Coating; XVIVO HMO 70100
HLS Set Advanced with BIOLINE Coating    Custom tubing packs for the oxygenator
HLS Set Advanced:  Small Adult 5.0 with BIOLINE Coating BEQ-HLS 5050, 70105.2797, Adult 7.0 with BIOLINE Coating BEQ-HLS 7050, 70105.2794 and Adult 7.0 with SOFTLINE Coating BO-HLS 7050, 70105.2786
Custom Tubing Packs     Custom tubing pack for oxygenators
containing products included in this action which include the following serial numbers; T xxxxx, TOP xxxxx, BE-TOP xxxxx, BO-TOP xxxxx, BO-T xxxxx, BEQ-T xxxxx,  and BEQ-TOP xxxxx.
Blood product, in which quality control and distribution/testing not performed, incompletely performed, or not documented, was distributed.
Neurotherm  NT2000iX RF Generator  Model Number: RFG-NT -2000iX
NT2000iX software shipped with the international setting turned on. The international settings include access to Corodotomy, Bi-Polar, and No Temperature modes were not cleared in the United States for use.
Worldwide Distribution-US (nationwide), Canada, Italy, Netherlands, Belgium, Norway, New Zealand, Poland, Sweden, Denmark, Slovenia, Turkey, South Africa, India, Israel, Hungary, Hong Kong, UK, Ireland, France, Finland, Spain, Portugal, Colombia, Chile, Germany, Austria, Switzerland, Kuwait, United Arab Emirates, Australia, Czech Republic, Bahrain, Lebanon, and Qatar.
Dexcom G5 Mobile Receiver  Receiver Part Number: MT22719 Receiver (mg/dL), Black; MT22719-PNK,  Receiver (mg/dL), Pink; MT22719-BLU, Receiver (mg/dL), Blue.  Intended to detect trends and track glucose patterns in persons with diabetes.
Customers may not receive an intended audible alarm or alert if relying on hearing the alarm or alert.
Dexcom G4 PLATINUM (Pediatric) Receiver  Receiver Part Number: MT22430 Receiver (mg/dL), Black (pediatrics); MT22430-PNK, Receiver (mg/dL), Pink (pediatrics); MT22430-BLU, Receiver (mg/dL); Blue (pediatrics).  Intended to detect trends and track glucose patterns in persons with diabetes.
Dexcom G4 PLATINUM Receiver with Share  Receiver Part Number: MT22495 Receiver (mg/dL), Black; MT22495-PNK,  Receiver (mg/dL), Pink; MT22495-BLU, Receiver (mg/dL), Blue.  Intended to detect trends and track glucose patterns in persons with diabetes.
Dexcom G4 PLATINUM (Pediatric) Receiver with Share  Receiver Part Number: MT22608 Receiver (mg/dL), Black (pediatrics); MT22608-PNK, Receiver (mg/dL), Pink (pediatrics); MT22608-BLU, Receiver (mg/dL), Blue (pediatrics).  Intended to detect trends and track glucose patterns in persons with diabetes.
Dexcom G4 PLATINUM Receiver  Receiver Part Number: MT20649 Receiver (mg/dL), Black; MT20649-PNK, Receiver (mg/dL), Pink; MT20649-BLU, Receiver (mg/dL), Blue.  Intended to detect trends and track glucose patterns in persons with diabetes.
Dexcom G4 PLATINUM (Professional) Receiver  Receiver Part Number: MT20649 Receiver (mg/dL), Black.  Intended to detect trends and track glucose patterns in persons with diabetes.    The G4 PLATINUM CGM System and G4 PLATINUM (Professional) CGM System use the same receiver, MT20649. The kits differ due to other kit contents, such as indications for use and professional receiver shield.
Blood product, which did not meet the acceptable product specifications, was distributed.
Worldwide Distribution - US Nationwide throughout the US and the countries of: Argentina, Australia, Austria, Bangladesh, Belgium, Brazil, Bulgaria, Czech Republic, Chile, China, Colombia, Costa Rica, Denmark, Dominican Republic, Ecuador, Egypt, El Salvador, France, Georgia, Greece, Guatlemala, Hungary, India, Indoesia, Isreal, Italy, Japan, Korea, Malaysia, Mexico, Netherlands, Nicaragua, Norway, Panama, Philippines, Portugal, Romania, Singapore, Slovakia, South Africa, Spain, Switzerland, Taiwan, Thailand, Trinidad and Tobago, Turkey, UK, Ukrain, United Arab Emirates
Alcon is conducting a voluntary medical device correction of all VERION Reference Units (Vision Planner) that are shared with the Alcon LenSx Laser System after receiving reports concerning the inclusion of unplanned arcuates on printed, saved (.pdf) or exported surgical plans.
Blood and Blood Products for Reprocessing
Blood product, collected from a donor who was at risk for variant Creutzfeldt-Jakob disease (vCJD), was distributed.
L'Bri Pure N' Natural Nutri Aloe Health Juice Drink 960 mL 32 FL. OZ. and L'Bri Pure N' Natural Nutri Aloe Health Juice Drink 1 FL OZ./29 mL
Product contains ingredients that are not on the label including sodium metabisulfite, to which a part of the population may be sensitive.
Hidden Valley Original Ranch dressing, 16 fl oz. ( 473 ml). plastic bottles;    Ingredients: Vegetable oil (soybean and/or Canola oil) water, egg yolk, sugar, Salt, Cultured non fat buttermilk, natural flavors (milk, soy), less than 1% spiced, dried garlic, dried onion, vinegar, phosphoric acid, xanthan gum, modified food starch, monosodium glutamate, artifical flavors, disodium phosphate, sorbic acid and calcium disodium EDTS as preservatives, disodium inosinate, disodium guanylate. Contains Egg, Milk, Soy, Gluten.    HV Food Products Co. Oakland, CA 94612
Incorrect ingredient labels inadvertently put on some bottles of salad dressing and therefore there is no declaration  of  soy lecithin as an ingredient.
Worldwide Distribution - Domestic: US Nationwide; Foreign: Argentina, Australia, Austria, Belarus, Belgium, Bosnia, Brazil Canada, Chile, China, Colombia, Croatia, Cyprus, Denmark, Egypt, Finland, France, Germany, Greece, Oman Kong, Iceland, India, Indonesia, Ireland, Israel, Italy, Japan, Jordan, Kazakhstan, , South Korea, Kuwait, Macedonia, Malaysia, Mexico, New Zealand, Norway, Oman, Pakistan, Paraguay, Peru, Philippines, Portugal, Qatar, Romania, Russia, Saudi Arabia, Serbia, Singapore, Slovenia, South Africa, Spain, Sweden, Switzerland, Taiwan, Thailand, The Netherlands, Turkey, United Arab Emirates, Ukraine, United Kingdom, Uruguay and Vietnam.
BARD ArcticGel Pads    Product Usage:  The Arctic Sun Temperature Management System is intended for monitoring and controlling patient temperature. ArcticGel Pads are only for use with an Arctic Sun Temperature Management System Control Module.
Complaints were received of restricted/inaccurate flow rate.
All lots with Catalog numbers: 31700 (Universal Pad), 3170004 (Universal Pad 4 pk), 31703 (XSmall pad kit), 3170302 (XSmall pad kit 2 pk), 31705 (Small pad kit), 3170502 (Small pad kit 2 pk), 31707 (Medium pad kit), 3170702 (Medium pad kit 2 pk), 31709 (Large pad kit) and 3170902 (Large pad kit 2 pk), that are within their current expiration dates.
Product was shipped to the following states: AZ, CA, FL, GA, IL, IN, KY, MA, MI, MO, MS, NM, OH, OK, TN & WI.      Product was also shipped to Ireland.
#2473 CINCINNATI STYLE CHILI Savory Net Wt. 4 lbs (1.8kg) UPC 0 90939 12473 1 GOLD MEDAL PRODUCTS 10700 MEDALLION DRIVE CINCINNATI, OHIO 45241
The firm discovered that the product failed to declare milk on the label.
Puredesi Whole Milk Yogurt in 5 lb.  plastic containers    Patidar Whole Milk Yogurt in 5 lb. plastic containers  Puredahi Whole Milk Yogurt in 5 lb. plastic containers    Sell by: 5/08/2016
228 - 5 lb. Puredesi containers; 180 - 5lb. Patidar containers; 480 - 5lb. Puredahi containers
yogurt that was produced on 2 different dates (February 23, 2016 and February 29, 2016)  in which the hold time was not held for the proper length of time to meet the requirements of pasteurization.
Puredesi Low Fat Yogurt in 2 lb. plastic containers  Puredesi Low Fat Yogurt in 5 lb. plastic containers  Puredahi Low Fat Yogurt in 2 lb. plastic containers
176 - 2lb. containers Puredesi; 156 - 5lb. containers Puredesi; 200 - 5lb Puredahi.
Tuna Salad Sandwich, Net Wt. 4.5 oz (128g) sold under the following brands and UPC:  1.  SuperMom's Bakery, UPC:  76391380124;  2. TakeAway Cafe, UPC:  76391310702;  3. Express Cafe, UPC:  76391380124  Keep Refrigerated.
Supermom's identified that the Tuna Salad Sandwich contains an undeclared allergen (milk).
Silver Source Canola Salad Oil, Net Wt. 35 LB (15.88 kg), Distributed by Performance Food Group, Richmond, VA 23238, UPC 0 08 06795 42770 7
Stratas Foods was informed by their 5 Galloon container Supplier, Ring Container that it is possible a 53 mm in diameter piece of plastic from the neck finish could be in the jugs that went to their co-manufacturer Oasis Foods.
Burger King Liquid Frying Oil, Net Wt. 35 LB (15.9 kg), Miami, Florida 33126, UPC 2 06 75258 06956 3
Silver Source Clear  Fry Oil, Net Wt. 35 LB (15.88 kg), Distributed by Performance Food Group, Richmond, VA 23238, UPC 008 06795 02237 3
Silver Source Creamy Fry Oil, Net Wt. 35 LB (15.88 kg), Distributed by Performance Food Group, Richmond, VA 23238, UPC 0 08 06795 02236 0
Silver Source Clear Canola Fry Oil, Net Wt. 35 LB (15.88 kg), Distributed by Performance Food Group, Richmond, VA 23238, UPC 0 08 06795 02237 7
Source Plasma, collected from an ineligible donor, was distributed.
Apheresis Platelets, Leukocytes Reduced, Irradiated
Blood products, which did not meet the acceptable product specifications, were distributed.
Blood products, exposed to unacceptable temperatures during storage, were distributed.
Nationwide Distribution to Nationwide in AL, AZ, CA, CO, CT, DC, GA, IL, MD, MI, MN, MO, NC, NH, NJ, NY, OH, OK, PA, TN, TX, VA..    Worldwide: AU, BE, BR, CA, CH, DE, DZ, EE, EG, ES, FI, FR, HK, HR, IL, IT, JO, KR, MX, NL, PL, SA, SE, SI, TR.
Diana Automated Compounding System, Diana Onco 3xx, Item No. ASN303  The Diana is an automated compounding device for the accurate, safe and efficient preparation of solutions by a pharmacist prior to delivery for infusion into patient.
ICU Medical Inc. has received a report of compounded volumes not meeting the accuracy specification by the Diana Compounding System when mixing volumes under 5ml.
Diana Automated Compounding System, Diana Onco Plus, Item No. ASN220  The Diana is an automated compounding device for the accurate, safe and efficient preparation of solutions by a pharmacist prior to delivery for infusion into patient.
Diana Automated Compounding System, Diana Onco Plus 1.2, Item No. ASN222, ASN222-GST, ASN222-R  The Diana is an automated compounding device for the accurate, safe and efficient preparation of solutions by a pharmacist prior to delivery for infusion into patient.
Diana Automated Compounding System, Final Assembly, Diana Onco Plus, Item No. CH5000, CH5000R  The Diana is an automated compounding device for the accurate, safe and efficient preparation of solutions by a pharmacist prior to delivery for infusion into patient.
Diana Automated Compounding System, Diana V1.3, Item No. CH5300, CH5300R  The Diana is an automated compounding device for the accurate, safe and efficient preparation of solutions by a pharmacist prior to delivery for infusion into patient.
Diana Automated Compounding System, Diana Onco Plus 1.3, Item No. ASN223  The Diana is an automated compounding device for the accurate, safe and efficient preparation of solutions by a pharmacist prior to delivery for infusion into patient.
Blood products, collected from a donor for whom donor suitability was not adequately determined, were distributed.
Nationwide in US: AL, AR, AZ, CA, CO, CT, DE, FL, GA, IA, IL, IN, KS, KY, LA, ME, MI, MO, MS, NC, NH, NJ, NY, OH, OK, OR, PA, RI, SC, TN, TX, UT, VA, WI
Bumble Bee Chunk Light Tuna in Oil, 48cans/case, 5oz., UPC 8660000021
Bumble Bee Foods is recalling 3 specific UPC codes of canned Chunk Light tuna due to process deviations that occurred in a co-pack facility not owned or operated by Bumble Bee.
Can Codes: TOODGSCEFB      Best Buy Dates: 02/23/2019
Bumble Bee Chunk Light Tuna in Water, 48cans/case, 5oz, UPC 8660000020
Can Codes:    TOA2BSCAFB, TOA3BSCAFB,  TOA4BSCAFB, TOA5BSCAFB, TOABBSCAFB, TOACBSCAFB, TOADBSCAFB, TOAEBSCAFB, TOG3BSCAFB, TOG4BSCAFB, TOH6BSCAFB, TOH7BSCAFB, TOHABSCAFB, TOHBBSCAFB, TOHCBSCAFB, TOHDBSCAFB, TOJ1BSCAFB, TOJ2BSCAFB, TOJ3BSCAFB, TOJ4BSCAFB, TON1BSCAFB, TON3BSCAFB, TOO1BSCAFB, TOO2BSCAFB, TOO3BSCAFB, TOO4BSCAFB, TOO5BSCAFB, TOOABSCAFB, TOOBBSCAFB, TOODBSCAFB, TOOEBSCAFB, TOOFBSCAFB,   TOR1BSCAFB, TOR4BSCAFB, TOR5BSCAFB      Best Buy Dates: 02/10/2019, 02/16/2019, 02/17/2019, 02/18/2019, 02/22/2019, 02/23/2019,  02/25/2019
Bumble Bee Chunk Light Tuna in Water, 6cans, 4pk, 5oz, UPC 8660000736
Can Codes: TOODGSCEFBTO9BBSCAFB, TO9DBSCAFB, TOA2BSCAFB, TON2BSCAFB, TON4BSCAFB, TON8BSCAFB, TONBBSCAFB, TONDBSCAFB, TONFBSCAFB, TOW1BSCAFB, TOW2BSCAFB, TOW3BSCAFB, TOW4BSCAFB, TOW5BSCAFB, TOWBBSCAFB, TOWEBSCAFB.    Best Buy Dates: 02/9/2019, 02/10/2019, 02/22/2019, 02/29/2019.
Tri-Union Seafoods, L.L.C dba Chicken of the Sea.
Nationwide in US: FL, SC, TX, OH, AL, NC
Chicken of the Sea 5 Oz. Canned Chunk Light Tuna in Oil, 48 cans per case, UPC code is 0 4800000195 5
Tri-Union Seafoods LLC is voluntarily recalling a limited amount of Chicken of the Sea brand 5 oz. canned chunk light tuna in oil and 5 oz. canned chunk light tuna in water.  This recall has been initiated because the product may have been undercooked due to an equipment malfunction, which was uncovered during a routine inspection.
6OA3Z SCEES  6OAAZ SCEES  6OABZ SCEEB  6OACZ SCEEB
Chicken of the Sea 5 Oz. Canned Chunk Light Tuna in Water, 48 cans per case, UPC code is 0 4800000245 7
6OJEB SCAEB  6OJCB SCAFB  6ONEBSCAIB  6OOFZ SCAFB  6ORDB SCAFB  6ORAB SCAFB   6L2CB SCAFB  6L32B SCAEB  6L33B SCAEB  6L35B SCAEB  6L3CB SCAEB
US Distribution to: FL, OR, NE, PA, NM, FL, VA, OH, WA, CA, MD, LA, ID, CN, TN, and DC.
X-Guide Surgical Navigation System, X-Clip Bulk Kit    The X-Guide Surgical Navigation System is a computerized navigational system intended to provide assistance in both the preoperative planning phase and the intra-operative surgical phase of dental implantation procedures.
The X-Guide system utilizes an X-Clip (PN P007665) which contains fiducials to assist with registration of the patient anatomy.  The X-Clip is a device worn intraorally by a patient during the CT scan and guided surgery procedures.  The X-Clip contains three fiducial markers made from a Stainless Steel material.  The X-Nav specification requires these fiducials be fabricated from Stainless Steel 3
Model Numbers: P007665 X-Clip; Component of System P007839.  Note: P007665 X-Clip Component is distributed as X-Clip Bulk Kit PN P008381, package of 12 pieces P007665.
Fenofibrate Capsules (Micronized) 134 mg, 500-count bottle, Rx Only, Distributed by Impax Generics, Hayward, CA 94544, NDC 0115-0522-02
28,001 HDPE bottles (14,000,500 capsules)
Labeling: Incorrect or Missing Lot and/or Exp. Date
Fenofibrate Capsules (Micronized) 200 mg, 500-count bottle, Rx Only, Distributed by Impax Generics, Hayward, CA 94544, NDC 0115-0533-02
42,239 HDPE bottles ( 21,119,500 capsules)
The label on the outer packaging does not match the product inside and intended use of the device.
Lot # 9984134, Catalog ID 08.803.051, OPAL Spacer 10 mm x 24 mm, 11 mm Height - Revolve
Blue Ridge Farms Supreme Tuna Salad; 09648; Net Weight 1 X 5 lb. Keep Refrigerated; Use By: 03/15/16; 03/17/16, 03/18/16; Lot # 436, 438, 439; Packed by Winter Gardens Quality Foods, Inc, New Oxford, PA 17350
The supplier of the salad oil used in the above product(s) has voluntarily recalled this raw material due to the potential presence of foreign material.  Winter Gardens is continuing this voluntary recall through the supply chain.
Blue Ridge Farms Cole Slaw Dressing; 23105; Net Weight: 1 X 10 lbs.; Keep Refrigerated; Use By: 03/26/16; Lot # 438; Packed by Winter Gardens Quality Foods, Inc, New Oxford, PA 17350
Blue Ridge Farms Krab Salad;09328; Net Weight 1 X 10 lb.; Keep Refrigerated; Use By: 03/15/16, 03/17/16;  Lot #436, 438;  Packed by Winter Gardens Quality Foods, Inc, New Oxford, PA 17350;    Krab Salad; 2872; Net Weight: 5 lb.; Keep Refrigerated; Use By: 3/02/16; Lot # 438; Packed by Winter Gardens Quality Foods, Inc, New Oxford, PA 17350;
Blue Ridge Farms Lemon Seafood Salad; 09526; Net Weight: 5 lbs.; Keep Refrigerated; Use By: 03/15/16; Lot # 436; Packed by Winter Gardens Quality Foods, Inc, New Oxford, PA 17350
Shrimp Salad; 0139; Net Weight: 5 lbs.; Keep Refrigerated; Use By: 03/19/16; Lot #440; Packed by Winter Gardens Quality Foods, Inc, New Oxford, PA 17350;
Blue Ridge Farms Potato Salad 01045;   Net Weight: 1 X 10 LB., Keep Refrigerated; Use by: 03/15/16, 03/22/16; Lot # 431, 438, Packed by Winter Gardens Quality Foods, Inc, New Oxford, PA 17350    Blue Ridge Farms Three Potato Salad; 01604; Net Weight: 1 X 10 lb.; Keep Refrigerated; Use by: 3/22/16; Lot #438; Packed by Winter Gardens Quality Foods, Inc, New Oxford, PA 17350    Three Potato Salad; 2992; Net Weight: 1-10 lbs.; Keep Refrigerated; Use By: 03/11/16; Lot # 438; Packed by Winter Gardens Quality Foods, Inc, New Oxford, PA 17350
Potato Salad - 95/10 lb. tubs; Three Potato Salad - 7/10 lb. tubs
Edamame In Oil; 2092; Net Weight:4 LB., Keep Refrigerated; Use by: 02/19/16, 02/24/16; Lot # 429, 433; Packed by Winter Gardens Quality Foods, Inc, New Oxford, PA 17350
Blue Ridge Farms Macaroni Salad; 05021  Net Weight: 1 X 10 LB., Keep Refrigerated; Use by: 03/14/16; Lot # 430;   Packed by Winter Gardens Quality Foods, Inc, New Oxford, PA 17350
Blue Ridge Farms  Vinegar & Oil Cole Slaw, 03010, Net Weight: 1 X 10 LB., Keep Refrigerated; Use by: 3/09/16, 3/20/16, 3/20/16; Lot # 425, 429, 436;   Packed by Winter Gardens Quality Foods, Inc, New Oxford, PA 17350    Picnic Cole Slaw; 2493 Net Weight: 10lbs; Keep Refrigerated; Use By: 03/22/16, 03/23/16; Lot #438, 439;  Packed by Winter Gardens Quality Foods, Inc, New Oxford, PA 17350      Picnic Cole Slaw 2505; Net Weight: 1-10lb.; Keep Refrigerated; Use By 03/22/16; Lot #438; Packed by Winter Gardens Quality Foods, Inc, New Oxford, PA 17350    Blue Ridge Farms; Cole Slaw, 03054, Net Weight: 1 X 10 LB., Keep Refrigerated; Use by: 3/23/16; Lot # 439; Packed by Winter Gardens Quality Foods, Inc, New Oxford, PA 17350
Blue Ridge Farms Seafood Salad; 09526; Net Weight: 5 lbs.; Keep Refrigerated; Use By: 03/10/16, 03/15/16, 03/17/16, 03/18/16; Lot #431, 436, 438, 439; Packed by Winter Gardens Quality Foods, Inc, New Oxford, PA 17350
Platelet product, which reached an unacceptable temperature during shipment, was distributed.
Red Blood Cells, Leukocytes Reduced, Irradiated
Blood products, collected from donors who were not appropriately evaluated for travel to a malarial endemic area, were distributed.
US Distribution to the states of : CA , CO, FL, IL. MN, MT, NY, OH, PA, TX, VA, VT, WA and WI.
Enzymatic Detergent and a cleaning pad in a re-sealable stand-up pouch).
Distributed to the states of AR, AZ, CA, CO, FL, IL, IN, KS, KY, LA, MD, MO, NC, NJ, NV, NY, OH, PA, SD, TN, TX, and WI.
Arthrex Deltoid Ligament Reconstruction Implant System.    Intended as a fixation post, a distribution bridge or for distributing suture tension over areas of ligament or tendon repair utilizing titanium buttons.
Potential for a component contained in the Implant System to be non-sterile.
Unique Device Identifier: 00888867131446; Catalog No.: AR-8918CP; Batch No.: 10020303.
Stryker Instruments Div. of Stryker Corporation
US Nationwide Distribution in the states of AR, AZ, CA, CT, FL, GA, IN, LA, MD, MN, MO, MS, NJ, NM, NY, OH, SC, SD, TN, TX and  UT.
SurgiCounter scanner, part of the SurgiCount Safety-Sponge System.   Model numbers 0694-097-000 and 0694-097-001.      Product Usage:   The SurgiCount Safety Sponge System is indicated for use in counting and recording the number of thermally labeled surgical sponges, laparotomy sponges, and towels used during surgical procedures.
The affected scanner does not correctly interact with the SC360 software. When docked pre/postoperatively, the affected SurgiCounter scanner may display an error message (code=2).  Also, the SurgiCounter scanner software version number is not appropriately displayed in the SC360 application during installation.
Becton, Dickinson and Company, BD Biosciences
Worldwide Distribution - US Distribution to the states of : CT, MN, FL, NY, CA, MA, DC, UT, VA and IN.,  and to the countries of :  Belgium, Brazil, Canada, China, India, Japan, Korea, Singapore and Taiwan.
BD-Retic-Count Reticulocyte Reagent System;    Hematology: Used for in vitro diagnostics
The carton label for one lot of BD Retic-Count Reticulocyte Reagent System had the incorrect storage conditions. The labels on the reagent as well as the Instructions for Use are correct.
Product number 349214, Lot number 5175559, Expiry 5/31/16.
Distributed in the states of AZ, CA, CO, CT, IL, IN, MD, MI, MN, NY, PA, SC, TN, WA, WI, and VA, and in the NETHERLANDS.
Tip, a surgical delay may occur while an alternate Tip Sleeve Assembly is retrieved.
Oklahoma Blood Institute - Sylvan N Goldman Center
Blood products, collected from a donor considered to be at increased risk for variant Creutzfeldt-Jakob Disease (vCJD), were distributed.
RBC's, collected using a Whole Blood Collection Scale for which quality control testing was not performed, were distributed.
Boston Scientific TSX Transseptal Needle, Model Number M004TSX60o;  Used to create the primary puncture in the interatrial septum when passing an intruder and/or catheter through the septum from the right side of the heart to the left side.
American National Red Cross, Greater Ozark-Arkansas Region
SOMATOM Definition AS, a family of CT systems intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission dta from either the same axial plane taken at different angles or spiral planes taken at different angles.
Siemens became aware that the front cover on some Siemens CT system was not properly welded.  It is possible for the welded-in threaded bolt to break out of the ground plate of the front cover if the cover is opened during service.  This could not happen during clinical operation.  Therefore, there is no potential risk for the user or patient and the CT System has no risk for a malfunction during
Model Number: SOMATOM Definition AS-8098027  Serial # SOMATOM Definition AS- 95766
Worldwide Distribution - US Nationwide in the countries Australia, Belgium, Brazil, Canada, Chile, Finland, France, Germany, Greece, Iceland, India, Israel, Italy, Netherlands, Qatar, Russia, Singapore, South Korea, Sweden, Switzerland, Taiwan, Turkey, United Arab Emirates, and United Kingdom.
da Vinci S Surgical System (IS4000) user manual English and OUS.    Product Usage:  The Intuitive Surgical Endoscope Instrument Control System (da Vinci Surgical System, Model IS4000) is intended to assist in the accurate control of Intuitive Surgical Endoscopic Instruments including rigid endoscopes, blunt and sharp endoscopic dissectors, scissors, scalpels, forceps/pick-ups, needle holders, endoscopic retractors, electrocautery and accessories for endoscopic manipulation of tissue, including grasping, cutting, blunt and sharp dissection, approximations, ligation, electrocautery, suturing and delivery and placement of microware and cryogenic ablation probes and accessories, during urologic surgical procedures, general laparoscopic surgical procedures, gynecologic laparoscopic surgical procedures, general thoracoscopic surgical procedures and thoracoscopically-assisted cardiotomy procedures. The system can also be employed with adjunctive mediastinotomy to perform coronary anastomosis during cardiac revascularization. The system is indicated for adult and pediatric use. It is intended to be used by trained physicians in an operating room environment in accordance with the representative, specific procedures set forth in the Professional Instructions for Use.
Intuitive Surgical has found that the use of instruments other than the Cardiac Probe Grasper (e.g. Large  Needle Driver Instrument) to manipulate the ablation probes during cardiac surgery can result in an increase of microscopic metallic particulates generated from the contact with the probes.
Model number 551457- IS4000 English:  Model number 551706 - IS4000 OUS
da Vinci S Surgical System (IS1200/IS2000/IS3000) user manual, instrument & accessory.    Product Usage:  The Intuitive Surgical Endoscopic Instrument Control System is intended to assist in the accurate control of Intuitive Surgical Endoscopic Instruments including rigid endoscopes, blunt and sharp endoscopic dissectors, scissors, scalpels, ultrasonic shears, forceps/pick-ups, needle holders, endoscopic retractors, stabilizers, electrocautery and accessories for endoscopic manipulation of tissue, including grasping, cutting, blunt and sharp dissection, approximation, ligation, electrocautery, suturing, and delivery and placement of microwave ablation probes and accessories during urologic surgical procedures, general laparoscopic surgical procedures, gynecological laparoscopic surgical procedures, general noncardiovascular thoracoscopic surgical procedures, and thoracoscopically assisted cardiotomy procedures. The system can also be employed with adjunctive mediastinotomy to perform coronary anastomosis during cardiac revascularization.It is intended for use by trained physicians in an operating room environment in accordance with the representative specific procedures set forth in the Professional Instructions for Use.
Model 550675; IS1200/IS2000/IS3000 - User Manual, Instrument & Accessory - all languages.
Haloperidol Decanoate Injection, 50 mg/mL, 1 mL vial, Rx Only. Fresenius Kabi USA LLC, Lake Zurich, IL 60047, NDC 63323-469-01.
Failed Impurities/Degradation Specifications: Firm is recalling product due to an impurity out-of-specification result.
EPIQ DIAGNOSTIC ULTRASOUND SYSTEM, Model EPIQ 5C, EPIC 5G, EPIQ 5W, EPIQ 7C, EPIC 7GC, and EPIQ 7W.    Diagnostic Ultrasound System for ultrasound imaging in abdominal, cardiac adult, cardiac other (fetal), cardiac pediatric, cerebral vascular, cephalic (adult), cephalic (neonatal), fetal/obstetric, gynecological, intraoperative (vascular), intraoperative (cardiac), musculoskeletal (conventional), musculoskeletal (superficial), other: urology, pediatric, peripheral vessel, small organ (breast, thyroid, testicle), transesophageal (cardiac), trans rectal, transvaginal.
11,085 units total (4909 units in the US and 6176 units outside the US)
The fasteners securing the control panel assembly to the base of the Philips EPIQ Ultrasound System may loosen over time, which could subsequently lead to the detachment of the entire assembly from the ultrasound system.
Simvastatin Tablets, USP 5 mg Rx only, a) 90 count (NDC 24658-0300-90) and b) 1000 count (NDC 24658-0300-10 )bottles, Manufactured by: Blu Caribe Dorado PR 00646, Manufactured for: Blu Pharmaceuticals Franklin, KY 42134
Fenofibrate Capsules (Micronized), 134 mg Capsules, 20-count Unit Dose Blister Packs per carton, Rx Only, Packaged and Distributed by: American Health Packaging Columbus, Ohio 43217, Carton of 20: NDC 68084-835-32, Individual Dose: NDC 68084-835-33.
Labeling: Incorrect or Missing Lot and/or Exp Date
Fenofibrate Capsules (Micronized), 200 mg , 30-count Unit Dose Blister Packs per carton, Rx Only, Packaged and Distributed by: American Health Packaging Columbus, Ohio 43217 Carton of 30:NDC 68084-835-32, Individual Dose: NDC 68084-835-33.
US nationwide in the states of ME, LA, and TN
Boston Scientific is voluntarily implementing a Medical Device Recall of one batch of PT Graphix Magnet J-TIP Guidewires.  Boston Scientific has found that, while the batch is labeled as a J-tip model, the guidewires are straight and do not have the pre-formed J-tip.  The most severe injury expected to occur is a limited procedure delay caused by the need to replace the guidewire with one that has
Blood products, collected from an ineligible donor, were distributed.
Cisatracurium Besylate Injection, 20 mg per 10 mL (2 mg per mL), For intravenous injection, 10 mL Multiple Dose Vial, Rx only, Fresenius Kabi USA, LLC  Lake Zurich, IL 60047, NDC 63323-417-10
Apheresis Platelets, lacking proper quality control testing, were distributed.
Blood product, collected from an ineligible donor, was distributed.