Blood products, collected in a manner that may have compromised the sterility of the collection system, were distributed.
Worldwide Distribution-US: AL AR AZ CA CO FL GA IL IN KS KY MA MI NY OH OR PA SC TX VA VT WA OUS: Argentina Australia Austria Bangladesh Belgium Brazil Canada Chile China Colombia Denmark Ecuador Estonia Ethiopia France Germany India Indonesia Iraq Ireland Italy Japan Jordan Korea, South Malaysia Mexico Netherlands New Zealand Norway Oman Palestine Poland Russian Federation South Africa Spain Sweden Switzerland Taiwan Turkey United Arab Emirates United Kingdom.
All Philips Ingenia, Intera, Achieva and Multiva MR systems using R5.1i and R5.1 .2 version of software.  Indicated for use as a diagnostic device. It can produce cross-sectional images, spectroscopic images and/or spectra in any orientation of the internal structure of the head, body, or extremities.
All Philips Ingenia, Intera, Achieva and Multiva MR systems using R5.1i and R5.1 .2 version of software
In spine clinical workflows, cross reference lines may be used to determine the position of slices. In cases, where MobiView fused Images are used to show the cross reference lines, the cross reference lines may be positioned incorrectly.
ONE-LINK NON-DEHP Y-TYPE MICROBORE CATHETER EXTENSION SET NEEDLE-FREE IV CONNECTOR WITH NEUTRAL FLUID DISPLACEMENT
Baxter Healthcare Corporation is voluntarily issuing a recall for lots UR15B16021 and UR15B23043 due to a potential for a leak at the tubing to luer bond.
Pharmacy Creations 540 Route 10 West Randolph, NJ 07869 Prazosin  0.5MG/ML SUSPENSION - 240 mL  1MG/ML SUSPENSION - 480 mL
API manufacturer Attix Pharmaceuticals notified Pharmacy Creations that finished veterinary products may have been exposed to penicillin products.
Pharmacy Creations 540 Route 10 West, Randolph, NJ 07869    Cetirizine 25mg/mL TDG - 3 mL  Cetirizine 20 mg/mL TDG - 3 mL  Cetirizine PF 10 mg/5mL Syrup - 300 mL
Pharmacy Creations 540 Route 10 West Randolph, NJ 07869   Aminopentamide 0.2MG Capsule
Seasoned Beanthread Salad (CHUKA ZENSAI), net wt. 2.2 lbs (1kg), Item No. 82021.   Chinese style appetizer labeled as SEASONED BEANTHREAD SALAD (CHUKA ZENSAI) packed in 1 kg clear plastic bags and placed in cardboard cartons containing twelve (12) bags per carton.  The bags of product do not bear any brand names.
Wismettac Asian Foods is recalling Seasoned Beanthread Salad (Chuka Zensai) due to lack of acidified food filing and registration.
JBN (Just Be Natural) Chocolate Mocha Confidence Nutritional Support for Bariatric Surgery 25G 100% WHEY ISOLATE NET WT. 43.9 oz. (2.7 lb) 1,230g and NET WT. 17.4 oz. (1.1 lb) 492g packaged in plastic bottles- DIETARY SUPPLEMENT; UPC Codes:  655455018294, 655455018195; MANUFACTURED BY NRS -Nutrition Resource Services, Inc.; DISTRIBUTED BY JBN -Just Be Natural; INGREDIENTS: Whey Protein Isolate, Soluable Corn Fiber, Coffee, Maltodextrin, Cocoa Powder, Carrageenan, Salt, Cocoa (alkali), Natural and Artificial Flavor, Sucralose. ALLERGEN STATEMENT: This product could have been transported, manufactured, or processed in a facility that contains milk, egg, fish, crustacean shellfish, tree nuts, wheat, peanuts and soybeans.
Protein powders and nutritional supplement products made of whey concentrate, whey isolate, casein, and colostrum are not labeled as containing milk
JBN (Just Be Natural) Red Velvet Deluxe Confidence Nutritional Support for Bariatric Surgery 25G 100% WHEY ISOLATE NET WT. 43.1 oz. (2.7 lb) 1,221g and NET WT. 18.3 oz. (1.1 lb) 518g packaged in plastic bottles - DIETARY SUPPLEMENT; UPC codes: 655455019864, 65545020204; MANUFACTURED BY NRS -Nutrition Resource Services, Inc. DISTRIBUTED BY JBN -Just Be Natural; INGREDIENTS: Whey Protein Isolate, Soluable Corn Fiber, Natural Flavor with other Natural Flavors, Sweet Buttermilk Powder, Cellulose, Xanthan and Carrageenan Gums, Sucralose, Salt, Cocoa (alkali). ALLERGEN STATEMENT: This product could have been transported, manufactured, or processed in a facility that contains milk, egg, fish, crustacean shellfish, tree nuts, wheat, peanuts and soybeans.
JBN (Just Be Natural) French Vanilla Cream Confidence Nutritional Support for Bariatric Surgery 25G 100% WHEY ISOLATE NET WT. 17.4 oz. (1.1 lb) 492g and   NET WT. 43.4 oz. (2.7 lb) 1,230g -   packaged in plastic bottles - DIETARY SUPPLEMENT; UPC codes: 655455018133, 655455018232; MANUFACTURED BY NRS -Nutrition Resource Services, Inc. DISTRIBUTED BY JBN -Just Be Natural; INGREDIENTS: Whey Protein Isolate, Soluable Corn Fiber, Maltodextrin, Natural Flavor with other Natural Flavors, Sucralose. ALLERGEN STATEMENT: This product could have been transported, manufactured, or processed in a facility that contains milk, egg, fish, crustacean shellfish, tree nuts, wheat, peanuts and soybeans.
JBN (Just Be Natural) Banana Cream Pie Confidence Nutritional Support for Bariatric Surgery 25G 100% WHEY ISOLATE NET WT. 17.3 oz. (1.1 lb) 490g and NET WT. 43.2 oz. (2.7 lb) 1,225g - packaged in plastic bottles; UPC codes: 655455020488 655455020495;  DIETARY SUPPLEMENT packaged in plastic bottles - MANUFACTURED BY NRS -Nutrition Resource Services, Inc. DISTRIBUTED BY JBN -Just Be Natural; INGREDIENTS: Whey Protein Isolate, Soluable Corn Fiber, Natural Flavor, Cellulose, Xanthan and Carrageenan Gums, Sucralose, Salt. ALLERGEN STATEMENT: This product could have been transported, manufactured, or processed in a facility that contains milk, egg, fish, crustacean shellfish, tree nuts, wheat, peanuts and soybeans.
Protein powders and nutritional supplement products made of whey concentrate, whey isolate, casein, and/or colostrum are not labeled as containing milk
JBN (Just Be Natural) Berry Delight Confidence Nutritional Support for Bariatric Surgery 25G 100% WHEY ISOLATE; NET WT. 44 oz. (2.7 lb) 1,247g and NET WT. 18.2 oz. (1.1 lb) 516g - packaged in plastic bottles; DIETARY SUPPLEMENT; UPC codes: 6554550202822, 655455020815, MANUFACTURED BY NRS -Nutrition Resource Services, Inc. DISTRIBUTED BY JBN -Just Be Natural; INGREDIENTS: Whey Protein Isolate, Soluable Corn Fiber, Maltodextrin, Natural and Artificial flavor, Red 40, Sucralose, Cellulose, Xanthan and Carrageenan Gums. ALLERGEN STATEMENT: This product could have been transported, manufactured, or processed in a facility that contains milk, egg, fish, crustacean shellfish, tree nuts, wheat, peanuts and soybeans.
JBN (Just Be Natural) Chocolate Truffle Confidence Nutritional Support for Bariatric Surgery 25G 100% WHEY ISOLATE; NET WT. 42.9 oz. (2.7 lb) 1,216g and NET WT. 17.4 oz. (1.1 lb) 494g- packaged in plastic bottles;  UPC codes: 655455020563, 66455020556, DIETARY SUPPLEMENT MANUFACTURED BY NRS -Nutrition Resource Services, Inc. DISTRIBUTED BY JBN -Just Be Natural; INGREDIENTS: Whey Protein Isolate, Cocoa (alkali), Soluable Corn Fiber, Maltodextrin, Natural Flavors with other Natural Flavors, Cellulose, Xanthan and Carrageenan Gums, Sucralose, Salt. ALLERGEN STATEMENT: This product could have been transported, manufactured, or processed in a facility that contains milk, egg, fish, crustacean shellfish, tree nuts, wheat, peanuts and soybeans.
JBN (Just Be Natural) Chocolate Confidence Nutritional Support for Bariatric Surgery 25G 100% WHEY ISOLATE; NET WT. 43.4 oz. (2.7 lb) 1,230g - packaged in plastic bottles,  UPC code: 655455018225, DIETARY SUPPLEMENT MANUFACTURED BY NRS -Nutrition Resource Services, Inc. DISTRIBUTED BY JBN -Just Be Natural; INGREDIENTS: Whey Protein Isolate, Maltodextrin, Soluable Corn Fiber, Cocoa (alkali), Cocoa Powder, Carrageenan, Salt, Sucralose. ALLERGEN STATEMENT: This product could have been transported, manufactured, or processed in a facility that contains milk, egg, fish, crustacean shellfish, tree nuts, wheat, peanuts and soybeans.
JBN (Just Be Natural) Earth Superior Whey Banana Cream Pie NET WT. 31.5 oz. (1.97 lb) 896g packaged in plastic bottles - DIETARY SUPPLEMENT; UPC code:  65545020136, MANUFACTURED BY NRS -Nutrition Resource Services, Inc. DISTRIBUTED BY JBN -Just Be Natural INGREDIENTS: Whey protein concentrate, Whey protein isolate, Natural Flavors, Cellulose, Xanthan and Carrageenan Gums, Natural Dried Agave, Salt, Stevia. ALLERGEN STATEMENT: This product could have been transported, manufactured, or processed in a facility that contains milk, egg, fish, crustacean shellfish, tree nuts, wheat, peanuts and soybeans.
JBN (Just Be Natural) Growtein Growth Protein Chocolate NET WT. 97 oz. (6 lb) 2750g packaged in plastic bottles - DIETARY SUPPLEMENT; UPC Code: 655455001678, MANUFACTURED BY NRS -Nutrition Resource Services, Inc. DISTRIBUTED BY JBN - Just Be Natural; INGREDIENTS: Whey protein concentrate, Whey protein isolate, Cocoa (alkali), Creatine Monohydrate, L-Glutamine, Maltodextrin, Cellulose, Xanthan and Carrageenan Gums, L-Valine, L-Isoleucine, L-Leucine, Natural Flavor with other Natural Flavors, Sucralose. ALLERGEN STATEMENT: This product could have been transported, manufactured, or processed in a facility that contains milk, egg, fish, crustacean shellfish, tree nuts, wheat, peanuts and soybeans.
JBN (Just Be Natural) Growtein Growth Protein Oatmeal Cookie NET WT. 98.8 oz. (6.17 lb) 2800g - DIETARY SUPPLEMENT, packaged in plastic bottles, UPC code: 655455001623, MANUFACTURED BY NRS -Nutrition Resource Services, Inc. DISTRIBUTED BY JBN - Just Be Natural; INGREDIENTS: Whey protein isolate, Whey protein concentrate, Creatine Monohydrate, L-Glutamine, Maltodextrin, Natural and Artificial Flavors, Cellulose, Xanthan and Carrageenan Gums, L-Valine, L-Isoleucine, L-Leucine, Soy Lecithin, Sucralose, Salt. ALLERGEN STATEMENT: This product could have been transported, manufactured, or processed in a facility that contains milk, egg, fish, crustacean shellfish, tree nuts, wheat, peanuts and soybeans.
JBN (Just Be Natural) Growtein Growth Protein Vanilla Cream NET WT. 97 oz. (6 lb) 2750g - DIETARY SUPPLEMENT packaged in plastic bottles, UPC code: 655455001661, MANUFACTURED BY NRS -Nutrition Resource Services, Inc. DISTRIBUTED BY JBN - Just Be Natural; INGREDIENTS: Whey protein concentrate, Whey protein isolate, Creatine Monohydrate, L-Glutamine, Maltodextrin, L-Valine, L-Isoleucine, L-Leucine, Soy Lecithin, Natural Flavor with other Natural Flavors, Cellulose, Xanthan and Carrageenan Gums, Sucralose, Salt. ALLERGEN STATEMENT: This product could have been transported, manufactured, or processed in a facility that contains milk, egg, fish, crustacean shellfish, tree nuts, wheat, peanuts and soybeans.
JBN (Just Be Natural) Cherry Crush 100% WHEY ISOLATE Enhanced Performance Nutrition NET WT. 41.3 oz. (2.58 lb) 1170g - DIETARY SUPPLEMENT; UPC codes: 65545502198, packaged in plastic bottles , MANUFACTURED BY NRS -Nutrition Resource Services, Inc. DISTRIBUTED BY JBN -Just Be Natural INGREDIENTS: Whey protein isolate, Maltodextrin, Natural and Artificial Flavor, Red 40, Soluable Corn Fiber, Cellulose, Xanthan and Carrageenan Gums, Sucralose.  ALLERGEN STATEMENT: This product could have been transported, manufactured, or processed in a facility that contains milk, egg, fish, crustacean shellfish, tree nuts, wheat, peanuts and soybeans.
JBN (Just Be Natural) Chocolate 100% WHEY ISOLATE Enhanced Performance Nutrition NET WT. 36 oz. (2.25 lb) 1020g - DIETARY SUPPLEMENT; UPC code: 66455017617, packaged in plastic bottles,  MANUFACTURED BY NRS -Nutrition Resource Services, Inc. DISTRIBUTED BY JBN -Just Be Natural INGREDIENTS: Whey protein isolate, Cocoa (alkali), Maltodextrin, Natural Flavor with other Natural Flavors, Soluable Corn Fiber, Cellulose, Xanthan and Carrageenan Gums, Sucralose. ALLERGEN STATEMENT: This product could have been transported, manufactured, or processed in a facility that contains milk, egg, fish, crustacean shellfish, tree nuts, wheat, peanuts and soybeans.
JBN (Just Be Natural) Chocolate Mocha 100% WHEY ISOLATE Enhanced Performance Nutrition NET WT. 36 oz. (2.25 lb) 1020g - DIETARY SUPPLEMENT; UPC code: 655455017686, packaged in plastic bottles , MANUFACTURED BY NRS -Nutrition Resource Services, Inc. DISTRIBUTED BY JBN -Just Be Natural INGREDIENTS: Whey protein isolate, Coffee, Cocoa (alkali), Maltodextrin, Natural and Artificial Flavor, Soluable Corn Fiber, Cellulose, Xanthan and Carrageenan Gums, Sucralose.  ALLERGEN STATEMENT: This product could have been transported, manufactured, or processed in a facility that contains milk, egg, fish, crustacean shellfish, tree nuts, wheat, peanuts and soybeans.
JBN (Just Be Natural) French Vanilla Cream 100% WHEY ISOLATE Enhanced Performance Nutrition NET WT. 36 oz. (2.25 lb) 1020g - DIETARY SUPPLEMENT; packaged in plastic bottles, UPC code: 655455017600, MANUFACTURED BY NRS -Nutrition Resource Services, Inc. DISTRIBUTED BY JBN -Just Be Natural INGREDIENTS: Whey protein isolate, Maltodextrin, Natural Flavor with other Natural Flavors, Soluable Corn Fiber, Cellulose, Xanthan and Carrageenan Gums, Sucralose. ALLERGEN STATEMENT: This product could have been transported, manufactured, or processed in a facility that contains milk, egg, fish, crustacean shellfish, tree nuts, wheat, peanuts and soybeans.
JBN (Just Be Natural) Unflavored 100% WHEY ISOLATE Enhanced Performance Nutrition; UPC code: 655455017594,  MANUFACTURED BY NRS -Nutrition Resource Services, Inc. DISTRIBUTED BY JBN -Just Be Natural NET WT. 27.5 oz. (1.72 lb) 780g - DIETARY SUPPLEMENT; packaged in plastic bottles,  INGREDIENTS: Whey protein isolate. ALLERGEN STATEMENT: This product could have been transported, manufactured, or processed in a facility that contains milk, egg, fish, crustacean shellfish, tree nuts, wheat, peanuts and soybeans.
JBN (Just Be Natural) Oatmeal Cookie 100% WHEY ISOLATE Enhanced Performance Nutrition NET WT. 31.7 oz. (1.98 lb) 900g - DIETARY SUPPLEMENT; UPC code: 655455017624, packaged in plastic bottles , MANUFACTURED BY NRS -Nutrition Resource Services, Inc. DISTRIBUTED BY JBN -Just Be Natural INGREDIENTS: Whey protein isolate, Maltodextrin, Soluable Corn Fiber, Natural and Artificial Flavors, Cellulose, Xanthan and Carrageenan Gums, Salt, Sucralose. ALLERGEN STATEMENT: This product could have been transported, manufactured, or processed in a facility that contains milk, egg, fish, crustacean shellfish, tree nuts, wheat, peanuts and soybeans.
JBN (Just Be Natural) Strawberries & Cream 100% WHEY ISOLATE, Enhanced Performance Nutrition NET WT. 33.9 oz. (2.11 lb) 960g - DIETARY SUPPLEMENT; packaged in plastic bottles, UPC code: 655455017662, MANUFACTURED BY NRS -Nutrition Resource Services, Inc. DISTRIBUTED BY JBN -Just Be Natural INGREDIENTS: Whey protein isolate, Maltodextrin, Natural and Artificial Flavor, Soluble Corn Fiber, Cellulose, Xanthan and Carrageenan Gums, Sucralose. ALLERGEN STATEMENT: This product could have been transported, manufactured, or processed in a facility that contains milk, egg, fish, crustacean shellfish, tree nuts, wheat, peanuts and soybeans.
JBN (Just Be Natural)Chocolate Recovery Fuel ISOLATE, Enhanced Performance Nutrition NET WT. 44.4 oz. (2.8 lb) 1260g - DIETARY SUPPLEMENT ; packaged in plastic bottles , UPC code: 655455117447, MANUFACTURED BY NRS -Nutrition Resource Services, Inc. DISTRIBUTED BY JBN -Just Be Natural OTHER INGREDIENTS: Whey protein isolate, Cocoa (alkali) d-alpha-Tocopheryl Acetate, Cyanocobalamin, Pyridoxine Hydrochloride, Ascorbic Acid, Sodium Chloride, Natural Flavor with other Natural Flavors, Sucralose. ALLERGEN STATEMENT: This product could have been transported, manufactured, or processed in a facility that contains milk, egg, fish, crustacean shellfish, tree nuts, wheat, peanuts and soybeans.
JBN (Just Be Natural) Creamsicle Recovery Fuel ISOLATE, Enhanced Performance Nutrition NET WT. 44.4 oz. (2.8 lb) 1260g - DIETARY SUPPLEMENT, packaged in plastic bottles, UPC code: 655455116976, MANUFACTURED BY NRS -Nutrition Resource Services, Inc. DISTRIBUTED BY JBN -Just Be Natural INGREDIENTS: Whey protein isolate, Natural and Artificial Flavors, d-alpha-Tocopheryl Acetate, Cyanocobalamin, Pyridoxine Hydrochloride, Ascorbic Acid, Sodium Chloride, Sucralose. ALLERGEN STATEMENT: This product could have been transported, manufactured, or processed in a facility that contains milk, egg, fish, crustacean shellfish, tree nuts, wheat, peanuts and soybeans
JBN (Just Be Natural) Chocolate Whey Superior NET WT. 29.6 oz. (1.85 lb) 840g and NET WT. 88.9 oz. (5.55 lb) 2,520g - DIETARY SUPPLEMENT, packaged in plastic bottles,  UPC codes: 655455020112, 655455001692, MANUFACTURED BY NRS -Nutrition Resource Services, Inc. DISTRIBUTED BY JBN -Just Be Natural INGREDIENTS: Whey protein concentrate, Whey protein isolate, Cocoa (alkali), Soluable Corn Fiber, Cellulose, Xanthan and Carrageenan Gums, Natural Flavor with other Natural Flavors, Salt, Sucralose. ALLERGEN STATEMENT: This product could have been transported, manufactured, or processed in a facility that contains milk, egg, fish, crustacean shellfish, tree nuts, wheat, peanuts and soybeans.
JBN (Just Be Natural) Banana Cake Whey Superior NET WT. 31.7 oz. (1.98 lb) 900g - DIETARY SUPPLEMENT, packaged in plastic bottles, UPC code: 655455020570, MANUFACTURED BY NRS -Nutrition Resource Services, Inc. DISTRIBUTED BY JBN -Just Be Natural INGREDIENTS: Whey protein concentrate, Whey protein isolate, Natural Flavor, Cellulose, Xanthan and Carrageenan Gums, Maltodextrin, Soluable Corn Fiber, Sucralose, Salt. ALLERGEN STATEMENT: This product could have been transported, manufactured, or processed in a facility that contains milk, egg, fish, crustacean shellfish, tree nuts, wheat, peanuts and soybeans.
JBN (Just Be Natural) French Vanilla Cream Whey Superior NET WT. 32.8 oz. (2.05 lb) 930g and NET WT. 98.4 oz. (6.15 lb) 2,790g - DIETARY SUPPLEMENT, packaged in plastic bottles, UPC codes: 655455001685, 655455001777, MANUFACTURED BY NRS -Nutrition Resource Services, Inc. DISTRIBUTED BY JBN -Just Be Natural INGREDIENTS: Whey protein concentrate, Whey protein isolate, Natural Flavor with other Natural Flavors, Soluable Corn Fiber, Cellulose, Xanthan and Carrageenan Gums, Maltodextrin, Salt, Sucralose. ALLERGEN STATEMENT: This product could have been transported, manufactured, or processed in a facility that contains milk, egg, fish, crustacean shellfish, tree nuts, wheat, peanuts and soybeans.
JBN (Just Be Natural) Chocolate Mocha Whey Superior NET WT. 33.9 oz. (2.11 lb) 960g - DIETARY SUPPLEMENT; packaged in plastic bottles, UPC code: 655455001814, MANUFACTURED BY NRS -Nutrition Resource Services, Inc. DISTRIBUTED BY JBN -Just Be Natural INGREDIENTS: Whey protein concentrate, Coffee, Whey protein isolate, Cocoa (alkali), Maltodextrin, Natural and Artificial Flavors, Cellulose, Xanthan and Carrageenan Gums, Sucralose. ALLERGEN STATEMENT: This product could have been transported, manufactured, or processed in a facility that contains milk, egg, fish, crustacean shellfish, tree nuts, wheat, peanuts and soybeans.
JBN (Just Be Natural) Chocolate Truffle Whey Superior NET WT. 30.7 oz. (1.92 lb) 870g - DIETARY SUPPLEMENT; packaged in plastic bottles,  UPC code: 655455020525, MANUFACTURED BY NRS -Nutrition Resource Services, Inc. DISTRIBUTED BY JBN -Just Be Natural INGREDIENTS: Whey protein concentrate, Whey protein isolate, Cocoa (alkali), Natural Flavor with other Natural Flavors, Soluable Corn Fiber, Sucralose, Cellulose, Xanthan and Carrageenan Gums, Salt. ALLERGEN STATEMENT: This product could have been transported, manufactured, or processed in a facility that contains milk, egg, fish, crustacean shellfish, tree nuts, wheat, peanuts and soybeans.
JBN (Just Be Natural) Oatmeal Cookie Whey Superior NET WT. 30.7 oz. (1.92 lb) 870g - DIETARY SUPPLEMENT; packaged in plastic bottles,  UPC code: 655455001821, MANUFACTURED BY NRS -Nutrition Resource Services, Inc. DISTRIBUTED BY JBN -Just Be Natural INGREDIENTS: Whey protein concentrate, Whey protein isolate, Natural and Artificial Flavors, Maltodextrin, Cellulose, Xanthan and Carrageenan Gums, Soluable Corn Fiber, Salt, Sucralose. ALLERGEN STATEMENT: This product could have been transported, manufactured, or processed in a facility that contains milk, egg, fish, crustacean shellfish, tree nuts, wheat, peanuts and soybeans.
JBN (Just Be Natural) Red Velvet Deluxe Whey Superior NET WT. 34 oz. (2.12 lb) 960g - DIETARY SUPPLEMENT, packaged in plastic bottles, UPC code: 655455020174, MANUFACTURED BY NRS -Nutrition Resource Services, Inc. DISTRIBUTED BY JBN -Just Be Natural INGREDIENTS: Whey Protein concentrate, Natural Flavor, Sweet Buttermilk Powder, Whey Protein isolate, Soluable Corn Fiber, Maltodextrin, Cellulose, Xanthan and Carrageenan Gums, Cocoa Powder, Salt, Sucralose. ALLERGEN STATEMENT: This product could have been transported, manufactured, or processed in a facility that contains milk, egg, fish, crustacean shellfish, tree nuts, wheat, peanuts and soybeans.
JBN (Just Be Natural) Unflavored Whey Superior NET WT. 27.5 oz. (1.72 lb) 780g - DIETARY SUPPLEMENT, packaged in plastic bottles,  UPC code:  655455001753, MANUFACTURED BY NRS -Nutrition Resource Services, Inc. DISTRIBUTED BY JBN -Just Be Natural INGREDIENTS: Whey protein concentrate. ALLERGEN STATEMENT: This product could have been transported, manufactured, or processed in a facility that contains milk, egg, fish, crustacean shellfish, tree nuts, wheat, peanuts and soybeans.
JBN (Just Be Natural) Strawberries & Cream Whey Superior NET WT. 31.7 oz. (1.98 lb) 900g - DIETARY SUPPLEMENT, packaged in plastic bottles, UPC code: 655455001807, MANUFACTURED BY NRS -Nutrition Resource Services, Inc. DISTRIBUTED BY JBN -Just Be Natural INGREDIENTS: Whey protein concentrate, Whey protein isolate, Natural and Artificial Flavor, Maltodextrin, Soluable Corn Fiber, Cellulose, Xanthan and Carrageenan Gums, Sucralose, Salt. ALLERGEN STATEMENT: This product could have been transported, manufactured, or processed in a facility that contains milk, egg, fish, crustacean shellfish, tree nuts, wheat, peanuts and soybeans.
JBN (Just Be Natural) Cinnamon Rice Pudding Casein Protein, Enhanced Performance Nutrition, NET WT. 32 oz. (2 lb) 910g - DIETARY SUPPLEMENT, packaged in plastic bottles, UPC code: 655455019567, MANUFACTURED BY NRS -Nutrition Resource Services, Inc. DISTRIBUTED BY JBN -Just Be Natural INGREDIENTS: Calcium caseinate, Maltodextrin, Natural Flavor with other Natural Flavors, Cinnamon, Cellulose, Xanthan and Carrageenan Gums, Sucralose. ALLERGEN STATEMENT: This product could have been transported, manufactured, or processed in a facility that contains milk, egg, fish, crustacean shellfish, tree nuts, wheat, peanuts and soybeans.
JBN (Just Be Natural) Vanilla Cream Casein Protein, Enhanced Performance Nutrition, NET WT. 32 oz. (2 lb) 910g - DIETARY SUPPLEMENT, packaged in plastic bottles, MANUFACTURED BY NRS -Nutrition Resource Services, Inc. DISTRIBUTED BY JBN -Just Be Natural INGREDIENTS: Calcium caseinate, Maltodextrin, Natural Flavor with other Natural Flavors, Cellulose, Xanthan and Carrageenan Gums, Sucralose. ALLERGEN STATEMENT: This product could have been transported, manufactured, or processed in a facility that contains milk, egg, fish, crustacean shellfish, tree nuts, wheat, peanuts and soybeans.
JBN (Just Be Natural) Natural Flavor Pure Whole Colostrum, 100% Bovine First Milking Colostrum, Enhanced Performance Nutrition, NET WT. 10.6 oz. (.66 lb) 300g  and NET WT. 21.2 oz. (1.32 lb) 600g - DIETARY SUPPLEMENT, packaged in plastic bottles, MANUFACTURED BY NRS -Nutrition Resource Services, Inc. DISTRIBUTED BY JBN -Just Be Natural; INGREDIENTS: Sunflower Lecithin, MCT oil.  ALLERGEN STATEMENT: This product could have been transported, manufactured, or processed in a facility that contains milk, egg, fish, crustacean shellfish, tree nuts, wheat, peanuts and soybeans.
Gifted Nutrition 100% Bovine Colostrum, in plastic bottles, Ingredients: Skim Colostrum, 30 servings, Gifted Nutrition Enterprises, Inc. , Miami, FL;
Batch number:  226110162014 Lot number:  130817A.
JBN (Just Be Natural) Confidence Unflavored 1.1 LBS and 2.7 LB
JBN (Just Be Natural) Confidence Strawberries & Cream- 25 G 100% whey isolate DIETARY SUPPLEMENT, packaged in plastic bottles,1.1 LBS and 2.7 LB  INGREDIENTS: Whey Protein Isolate, Soluable Corn Fiber, Maltodextrin,  Artificial Flavor, Sucralose.MANUFACTURED BY NRS - Nutrition Resource Services, Inc. DISTRIBUTED BY JBN - Just Be Natural; ALLERGEN STATEMENT: This product could have been transported, manufactured, or processed in a facility that contains milk, egg, fish, crustacean shellfish, tree nuts, wheat, peanuts and soybeans.
JBN (Just Be Natural) Whey Superior Chocolate Peanut Butter packaged in plastic bottles - DIETARY SUPPLEMENT 2.11 LB; INGREDIENTS: Whey protein concentrate, Natural Flavor, Sweet Buttermilk Powder, Whey protein isolate, Soluable Corn Fiber, Maltodextrin, Cellulose, Xanthan and Carrageenan Gums, Cocoa Powder, Salt, Sucralose. MANUFACTURED BY NRS -Nutrition Resource Services, Inc. DISTRIBUTED BY JBN -Just Be Natural; ALLERGEN STATEMENT: This product could have been transported, manufactured, or processed in a facility that contains milk, egg, fish, crustacean shellfish, tree nuts, wheat, peanuts and soybeans.
JBN (Just Be Natural) Growtein Candy Bar Blitz 6.17 LB and 3.1 LB  packaged in plastic bottles - DIETARY SUPPLEMENT; UPC 655455020211, 655455020464; INGREDIENTS: Whey protein isolate, whey protein concentrate, Cocoa (alkali), Creatine Monohydrate, Natural and Artificial flavor, Maltodextrin, L-Glutamine, Cellulose, Xanthan and Carrageenan Gums, L-Valine, L-Isoleucine, L-Luecine, Sucralose. MANUFACTURED BY NRS -Nutrition Resource Services, Inc. DISTRIBUTED BY JBN -Just Be Natural; ALLERGEN STATEMENT: This product could have been transported, manufactured, or processed in a facility that contains milk, egg, fish, crustacean shellfish, tree nuts, wheat, peanuts and soybeans
JBN (Just Be Natural) Confidence Chocolate Peanut Butter 1.1 LB and 2.7 LB  packaged in plastic bottles - DIETARY SUPPLEMENT 2.11 LB; UPC 655455020501, 655455020518; INGREDIENTS: Whey protein isolate, Soluable Corn Fiber, Natural Flavor, Sweet Buttermilk Powder, Cellulose, Xanthan and Carrageenan Gums, Cocoa Powder, Salt, Sucralose. MANUFACTURED BY NRS -Nutrition Resource Services, Inc. DISTRIBUTED BY JBN -Just Be Natural; ALLERGEN STATEMENT: This product could have been transported, manufactured, or processed in a facility that contains milk, egg, fish, crustacean shellfish, tree nuts, wheat, peanuts and soybeans
Platelet products, collected on an instrument that failed leukoreduction quality control, were distributed.
US Nationwide Distribution in the states of IL, IN, LA, OH, PA, TX & WV.
OneTray Sealed Sterilization Containers   Product Usage:  A rigid sterilization container used to steam sterilize medical devices
The wrong sterilization time was on the label. The label lists Steam Gravity 10 - 34 minutes at  270 degrees F instead of Steam Gravity 17 - 34 minutes at 270 degrees F.
Natus neoBLUE 3 Phototherapy system or Neonatal Phototherapy, Catalogue Part Number:  010066; Top Assembly Part Number: 001103
The neoBLUE Instruction For Use (IFU) and Service Manuals for the neoBLUE 3 were revised to show the cleared intensity statement settings so the output intensity aligns precisely with the information listed in the cleared 510(k) submission.
Blood products, collected from a donor who was at risk for variant Creutzfeldt-Jakob Disease (vCJD), were distributed.
Blood products, collected from an ineligible donor, were distributed.
Ambitex NMD400 Nitrile Exam Gloves size medium. General Hospital and Personal use.   Intended to be worn on the hand for medical purposes to provide a barrier against potentially infectious materials and other contaminants.
Ambitex NMD400 Nitrile Exam Glove LOT NUMBER: 25314
Ambitex Nitrile NMD400 Exam Gloves size medium on exam hold were inadvertently placed into commerce. The product was under Exam Hold because samples pulled from a shipment manufactured by the firm failed the water leak test performed by FDA as described at 21 CFR 800.20.
Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Distributed Nationwide and in Germany, Switzerland, and UK.
ConForMIS iUni Unicondylar Knee Replacement System:   iUNI G2, Left Lateral  Catalog Number: M57220600230 (US)                                   M5722INT0600230  (OUS)
May contain small amounts of ethylene glycol residue
ConForMIS Unicondylar Knee Replacement System iUNI G2, Left Medial  Catalog Number: M57220600210(US)                                  M5722INT0600210 (OUS)
ConForMIS iUNI Unicondylar Knee Replacement System  iUNI G2, Right Lateral  Catalog Number:  M57220600240 (US)                                   M5722INT0600240 (OUS)
ConForMIS iUni Unicondylar Knee Replacement System- iUNI G2, Right Medial  Catalog Number:M57220600220 (US)                                   M5722INT0600220 (OUS)
ConForMIS iDuo Bicompartmental Knee Replacement System  iDUO G2, Left Lateral Catalog Number: M57230600230
ConForMIS iDuo Knee Bicompartmental Knee Replacement System , iDUO G2, Right Medial  Catalog Number: M57230600220 (US)                                  M5723INT0600220 (OUS)
ConFormis iTotal CR Knee Replacement System- ITOTAL CR - IPOLY - IMPLANT KIT UNCAPTURED - LEFT  ITOTAL CR - IPOLY - IMPLANT KIT UNCAPTURED - RIGHT  Catalog Number: TCR1111111
ConForMIS iTotal CR (Cruciate Retaining) Knee Replacement System-iTOTAL CR, Left Knee Catalog Number: M57250600010 (US)                                  M5725INT0600010 (OUS)
ConFormis iTotal CR Knee Replacement System- iTOTAL CR, Right Knee  Catalog Number: M57250600020 (US)                                  M5725INT0600020 (OUS)
ConFormis iTotal Posterior Stabilized Knee Replacement System-  ITOTAL PS-IPOLY- IMPLANT KIT-LEFT and   ITOTAL PS-IPOLY-IMPLANT KIT-RIGHT  Catalog Number:TPS1111111
ConFormis iDUO G2, Right Lateral Catalog Number: M5723INT0600240 (US)                                   M5723INT0600240 (OUS)
American Natl. Red Cross-Greater Chesapeake & Potomac Region
Red Blood Cells (Apheresis) Leukocytes Reduced
W205315260524 (double collection); W205315253794 (double collection)
Blood products, for which testing was not performed according to manufacturer's instructions, were distributed.
Platelet products, which did not meet specifications, were distributed.
Worldwide Distribution: US (nationwide) to CA only and countries of: Australia, Belgium, Germany, Hungary, Italy, Sweden, and Switzerland.
PORT-A-CATH Plastic Hub Needles, 0.9mm (20G) x 19mm (3/4 in.) 90-degree.  REF 21-2287-24   The Plastic hub PORT-A-CATH (PAC) needles are intended to access the implantable portal system for the purpose of infusion or withdrawal of fluids. These PAC needles can be used with standard luer lock connectors.
The label on the lid stock of the individual needle packages for a portion of Lot number 46262 contains the incorrect part number, part number description and product image.  The part number should be 21-2287-24 Port-A-Cath Plastic Hub Bent Needle.
Blood product, which did not meet the acceptable product specifications, was distributed.
W084214001000 (double collection); W084215000831 (double collection)
Platelet products, which were labeled as leukoreduced, but did not meet leukoreduction criteria, were distributed.
5.0mm Unit Rod 270mm, 5.0mm Unit Rod 290mm, 5.0mm Unit Rod 310mm,  5.0mm Unit Rod 330mm, 5.0mm Unit Rod 350mm, 5.0mm Unit Rod 370mm,   5.0mm Unit Rod 390mm, 5.0mm Unit Rod 410mm, 5.0mm Unit Rod 430mm,   5.0mm Unit Rod 450mm; Orthosis, Spinal, Pedicle fixation    Intended to provide immobilization and stabilization of spinal segments in skeletally mature patients.
This product was produced using a finishing process not identified as part of the manufacturing specification.  The process used with the lots subject to this Recall was a bead blast process. (Bead Blasting vs. Shot Peened).
Blood product, in which quality control and distribution of product did not meet specifications, was distributed.
Taco Seasoning #87469 Net Wt. 9 oz. MFG By Major Products Co., Inc., Little Ferry, NJ 07643  no upc code
Major Products is recalling taco seasoning due to potential peanut contamination which is less than 2.5 ppm..
Worldwide Distribution - US Nationwide, Canada, Austria, Australia, Belgium, China, Spain, Finland, France, Great Britain, Greece, Germany, Hungary, India, Italy, Japan, Korea, Lithuania, Latvia, Netherlands, Poland, Portugal, Sweden, Thailand, Turkey, Ukraine and Venezuela
Smith & Nephew MOSAICPLASTY DP- Disposable Harvesting System 3.5 mm, Sterile Part Number:  7209234    Intended Use: For arthroscopic (knee and ankle) and open osteochondral grafting fix for osteochondral (cartilage) defects.
Sterility of device is compromised due to breach in the packaging
Smith & Nephew MOSAICPLASTY DP- Disposable Harvesting System 4.5 mm, Sterile Part Number:  7209235    Intended Use: For arthroscopic (knee and ankle) and open osteochondral grafting fix for osteochondral (cartilage) defects.
Smith & Nephew MOSAICPLASTY DP- Disposable Harvesting System 6.5 mm, Sterile Part Number:  7209236    Intended Use: For arthroscopic (knee and ankle) and open osteochondral grafting fix for osteochondral (cartilage) defects.
Smith & Nephew MOSAICPLASTY DP- Disposable Harvesting System 8.5 mm, Sterile Part Number:  7209237    Intended Use: For arthroscopic (knee and ankle) and open osteochondral grafting fix for osteochondral (cartilage) defects.
US Distribution to states of: PA, FL, ID, and CA.
AltiVate Humeral Socket Shell Trial, Part Number 804-06-052   The glenoid baseplate is intended for cementless application with addition of screws for fixation. The humeral stem is intended for cemented or cementless use. This device may also be indicated in the salvage of previously failed surgical attempts. Shoulder reconstructive surgery should be reserved for patients who have failed non-operative treatments.
Difficulty assembling the shell trial to the broach and the retaining ring disassembled from the screw.
U.S. distribution nationwide. Foreign distribution to the following; Canada and Malaysia
Karoun Dairies is recalling all cheese manufactured from an identified manufacturer due to potential Listeria monocytogenes contamination.
California Cheese 3 lb, 25 lb  UPC Codes:  7 96252 90030 3    Product is packaged in plastic pails.
Farmer's Goat Cheese 8 oz  UPC Codes:  7 96252 50016 9    Product is vacuum packed.
Queso Fresco 8 oz, 13 lb    UPC Codes:  7 96252 80083 2, 7 96252 80081 8    Product is vacuum packed.
Goat Milk Feta 8 oz    UPC Codes:  7 96252 50001 5    Product is vacuum packed and packaged in pails.
Mozzarella Ball Old Country Style  Net Wt. 1lb.     UPC Codes:  7 96252 70012 5, 7 96252 70013 2, 7 96252 12014 5,  7 96252 12015 2    Product is vacuum packed.
Authentic Braided String Cheese Jumbo Braided String Cheese  Braided Whole Milk String Cheese  Braided String Cheese Original   Oaxaca  8oz, 13oz., 8lb.    Product is vacuum packed, plastic containers, or packed on styrofoam trays wrapped in plastic.
Ani 3 lb, 20 oz    UPC Codes:  7 96252 01125 2, 7 96252 00323 3    Product is packaged in plastic pails and jars.
Nabulsi Cheese 16 oz, 25 lb    UPC Codes:  7 96252 03225 7, 7 96252 00225 0, 7 96252 00223 6,  7 96252 00125 3    Product is vacuumed packed or packaged in pails.
Grilling Cheese 8 oz, 2.5 lb    UPC Codes:  96252 90024 2, 7 96252 90029 7    Product is vacuum packed.
Ackawi Cheese in Brine 20 oz    UPC Codes: 7 96252 01123 8, 7 96252 03223 3     Product is packaged in jars.
Village Cheese with Natural Hickory Smoke 6 lb    UPC Codes:   7 96252 00129 1    Product is vacuum packed.
Feta Basket Cheese With Green Olives & Thyme 8 oz    UPC Code:   7 96252 22006 7    Product is vacuum packed.
Feta Basket Cheese With Kalamata Olives & Thyme 8 oz    UPC Code:   7 96252 22007 4    Product is vacuum packed.
Feta Basket Cheese With Sun Dried Tomato, Thyme & Red Pepper 8 oz.    UPC Codes: 7 96252 22005 0    Product is vacuum packed.
Mozzarella  Natural Hickory Smoked  Net Wt. 1lb.    UPC Codes:  7 96252 70012 5, 7 96252 70013 2, 7 96252 12014 5,  7 96252 12015 2    Product is vacuum packed.
Worldwide Distribution-Domestic: AK, AL, AZ, CA, CO, CT, DC, FL, IN, IL, KY, MA, MD, MI, MN, MO, NJ, NC, ND, NY, OH, OK, PA, PR, TN, TX, VA, WA and WI; International: Albania, Argentina, Australia, Austria, Bahamas, Bahrain, Bangladesh, Belarus, Belgium, Bosnia and Herzegovina, Botswana, Brazil, Canada, Chile, China, Colombia, Croatia, Cyprus, Czech Republic, Ecuador, Egypt, Estonia, France, Gabon, Germany, Greece, India, Indonesia, Iraq, Ireland, Israel, Italy, Japan, Jordan, Libya, Macedonia, Malaysia, Mali, Malta, Mexico, Morocco, Myanmar, Netherlands, New Zealand, Pakistan, Peru, Philippines, Poland, Portugal, Romania, Russia, Saudi Arabia, Serbia, Singapore, Slovakia, South Africa, South Korea, Spain, Suriname, Switzerland, Taiwan, Thailand, Turkey, The United Kingdom, Ukraine, Venezuela and Vietnam.
XiO Radiation Treatment Planning System. Used to create treatment plans for any cancer patient for whom external beam radiation therapy or brachytherapy has been prescribed.
Incorrect Treatment Delivery Using Third Party Fixed Wedges.
Perifix Continous Epidural Anesthesia Pain Control Trays; Injection of anesthetics to provide regional anesthesia for pain management.
Potential discoloration of the DuraPrep solution from unintended exposure to the sterilant during sterilization performed by the supplier.
Blood products, with a possibility of air contamination, were distributed.
Worldwide Distribution - US (nationwide), Canada, and Germany
TELETOM EQUIPMENT MANAGEMENT SYSTEM 4 and 6 series TELETOM is designed for use in operating rooms, medical treatment rooms, intensive care units, or any area of a medical facility that requires a ceiling mounted device to supply power, medical gases, and data-communication services. TELETOM is designed to be used in rooms that have been constructed to meet National Fire Protection Association.
During the use of the TELETOM Series 4 & 6 there is potential for the controls and brakes not to work properly due to fluid intrusion within the control switches and/or the control board assembly.
Sanofi Pasteur's 2014-2015 Fluzone Quadrivalent (Influenza Vaccine) Supplied in Multidose Vials
Three lots of Sanofi Pasteur's 2014-2015 Fluzone Quadrivalent (Influenza Vaccine) supplied in Multidose vials, with antigen content that declined below the stability specification limit for two strains prior to product expiry, were distributed.
nationwide and outside the US to include Guam.
General Mills Cheerios, Toasted Whole Grain Oat Cereal, packaged in the following sizes:  12 oz, UPC 16000-48772;  18 oz, UPC 16000-27528
Better if Used by Dates:  14JUL2016 LD - 17JUL2016 LD
General Mills is recalling several days of production of Cheerios and Honey Nut Cheerios Cereal because of undeclared wheat.
General Mills Honey Nut Cheerios, Whole Grain Oats, packaged in the following sizes:  12.25 oz., UPC 16000-27527;  17 oz., UPC 16000-27571;  48 oz., UPC 16000-48665;  and 55 oz., UPC 16000-40106
Best if Used by Dates:  12JUL2016 LD - 25JUL2016 LD
Nationwide Distribution including CA, FL, OK, NY, NC, and IL.
Neuro Combo Set Case The cases hold surgical instrumentation in place during handling and storage.
The lids on implant caddies within P/N 17-5000 and 19-5000 could not be opened by the user without application of undesirable/unexpected excessive force.
Thinflap System Case The cases hold surgical instrumentation in place during handling and storage.
Misbranded Anitbody Identification Panel was distributed.
Amidate (Etomidate Injection, USP), 40 mg/20 mL (2 mg/mL), LifeShield, 20 mL, Glass Abboject Syringe with male luer lock adapter, Rx only, Hospira, Inc., Lake Forest, IL 60045, NDC 0409-8060-29
Failed Impurities/Degradation Specifications: Out of Specification(OOS) results for degradation product of etomidate was confirmed during stability testing.
Donnatal (Phenobarbital, Hyoscyamine Sulfate, Atropine Sulfate, Scopolamine Hydrobromide) tablets, 100-count bottle, Rx only, Manufactured for Concordia Pharmaceuticals, Inc., St. Michael, Barbados BB11005, Manufactured by IriSys, LLC San Diego, CA 92121, Repackaged by: RxPak, Div. of McKesson, Memphis, TN 38141, NDC 59212-425-10
Labeling: Not elsewhere classified - Product label incorrectly lists Scopolamine Hydrocodone as an active ingredient on the side panel instead of Scopolamine Hydrobromide.