Vereinigte Staaten Recalls
Verbraucherrückrufe von FDA, CPSC, NHTSA und USDA FSIS.
FDA FoodJoy Plain Chaash Lassi 16 oz., 64 oz.
Joy Plain Chaash Lassi 16 oz., 64 oz.
Product not adequately pasteurized
FDA Food1) Spring & Mulberry Pure Dark Date-Sweetened Chocolate, Net Wt. 2.1 oz. (60g), individually packaged in a navy blue box, UPC 850055470002, Dist. By Spring & Mulberry Raleigh, NC 27606. Wholesale product packed 48 bars (caddied)/56 bars (uncaddied) per case. Retail product sold individually or as a 3-pk, 6-pk, or 12-pk (Amazon only). 2) Spring & Mulberry Pure Dark Minis Date-Sweetened Chocolate, Net Wt. 0.75 oz. (22g), individually packaged in a navy blue box, UPC 850055470132, Dist. By Spring & Mulberry Raleigh, NC 27606. Wholesale product packed 64 bars (caddied)/204 bars (uncaddied) per case. Retail product sold individually or as a 3-pk, 6-pk, or 12-pk (Amazon only).
1) Spring & Mulberry Pure Dark Date-Sweetened Chocolate, Net Wt. 2.1 oz. (60g), individually packaged in a navy blue box, UPC 850055470002, Dist. By Spring & Mulberry Raleigh, NC 27606. Wholesale product packed 48 bars (caddied)/56 bars (uncaddied) per case. Retail product sold individually or as a 3-pk, 6-pk, or 12-pk (Amazon only). 2) Spring & Mulberry Pure Dark Minis Date-Sweetened Chocolate, Net Wt. 0.75 oz. (22g), individually packaged in a navy blue box, UPC 850055470132, Dist. By Spring & Mulberry Raleigh, NC 27606. Wholesale product packed 64 bars (caddied)/204 bars (uncaddied) per case. Retail product sold individually or as a 3-pk, 6-pk, or 12-pk (Amazon only).
Potential Salmonella contamination
FDA FoodJoy Saffron Cardamon Lassi 16 oz.
Joy Saffron Cardamon Lassi 16 oz.
Product not adequately pasteurized
FDA FoodJoy Mango Lassi 16 oz., 64 oz.
Joy Mango Lassi 16 oz., 64 oz.
Product not adequately pasteurized
FDA DevicesVOCSN+Pro package, REF: PRT-00853-000; VOCSN+Pro unit, REF: PRT-00490-001
VOCSN+Pro package, REF: PRT-00853-000; VOCSN+Pro unit, REF: PRT-00490-001
Respiratory system intended to provide continuous/intermittent ventilator support, may have a damaged back-up battery supporting backup alarm function, which may result in the backup alarm not activating during loss of primary power and absence/depletion of backup power sources, which may result in delayed caregiver awareness of a hazardous condition.
FDA Food2.0 oz Dirty Sour Cream and Onion Potato Chips, Plastic Bag.
2.0 oz Dirty Sour Cream and Onion Potato Chips, Plastic Bag.
Potential presence of Salmonella.
FDA Food1.5oz, 2oz Dirty Brand Salt and Vinegar Potato Chips , Plastic Bag.
1.5oz, 2oz Dirty Brand Salt and Vinegar Potato Chips , Plastic Bag.
Potential presence of Salmonella.
FDA Food6/11oz No Salt Sunflower Seeds
6/11oz No Salt Sunflower Seeds
The firm is recalling sunflower seed products due to the presence of an undeclared tree nut allergen, cashew.
FDA Food2.0 oz Dirty Maui Onion Chip, Plastic Bag.
2.0 oz Dirty Maui Onion Chip, Plastic Bag.
Potential presence of Salmonella.
FDA FoodJoy Mango-Pina-Orange Lassi 16 oz., 64 oz.
Joy Mango-Pina-Orange Lassi 16 oz., 64 oz.
Product not adequately pasteurized
FDA DevicesSurgify Halo, 4.0 mm, Short, Model/Catalog Number: 40.070.NVG.U1; drills, burrs, trephines & accessories (simple, powered)
Surgify Halo, 4.0 mm, Short, Model/Catalog Number: 40.070.NVG.U1; drills, burrs, trephines & accessories (simple, powered)
Potential for burr breakage, occurring during bi-portal endoscopic spinal surgery (BESS).
FDA DevicesTMJ Bilateral Implants, REF: CHG020
TMJ Bilateral Implants, REF: CHG020
Custom temporomandibular joint implant may have contained incorrect patient-specific components that led to a poor fit of the implant, leading to a right-sided open bite.
FDA DevicesOff-Axis Alliance Glenoid, Right, 4-Peg, Augment, Reamer Guide, Model/Catalog Number: 110040476
Off-Axis Alliance Glenoid, Right, 4-Peg, Augment, Reamer Guide, Model/Catalog Number: 110040476
Five complaints have been received identifying issues where the plastic guides were catching during reaming, leading to breakage.
FDA FoodJoy Strawberry Lassi 16 oz.
Joy Strawberry Lassi 16 oz.
Product not adequately pasteurized
FDA DevicesBrand Name: Persona Revision Product Name: Persona Revision¿ Trabecular Metal¿ Femoral Distal Augment Model/Catalog Number: 42-5572-066-10 Software Version: N/A Product Description: Persona Revision¿ Trabecular Metal¿ Femoral Distal Augment Size 9, 9+ 10mm Thicknes Component: N/A
Brand Name: Persona Revision Product Name: Persona Revision¿ Trabecular Metal¿ Femoral Distal Augment Model/Catalog Number: 42-5572-066-10 Software Version: N/A Product Description: Persona Revision¿ Trabecular Metal¿ Femoral Distal Augment Size 9, 9+ 10mm Thicknes Component: N/A
Firm received a complaint with no clinical impact in which a posterior augment was found within the distal augment package.
FDA DevicesSurgify Halo, 5.4 mm, Medium, Model/Catalog Number: 54.085.SHD.U1; drills, burrs, trephines & accessories (simple, powered)
Surgify Halo, 5.4 mm, Medium, Model/Catalog Number: 54.085.SHD.U1; drills, burrs, trephines & accessories (simple, powered)
Potential for burr breakage, occurring during bi-portal endoscopic spinal surgery (BESS).
RSS FeedEunha Fisheries Co., LTD. Issues Allergy Alert on Undeclared Wheat, Soy, and Sesame in Certain Frozen Olive Flounder Sashimi Products
Eunha Fisheries Co., LTD. Issues Allergy Alert on Undeclared Wheat, Soy, and Sesame in Certain Frozen Olive Flounder Sashimi Products
FDA Food1.5oz, 8.0oz , Zapp's Big Cheezy Potato Chips, Plastic Bag.
1.5oz, 8.0oz , Zapp's Big Cheezy Potato Chips, Plastic Bag.
Potential presence of Salmonella.
FDA DevicesConvenience kits containing select SKUs of 10mL Polycarbonate Colored Syringes. KIT NEURO CSTM SAMP0551
Convenience kits containing select SKUs of 10mL Polycarbonate Colored Syringes. KIT NEURO CSTM SAMP0551
Firm identified unapproved design changes to the products outside of the 510(k) cleared by the FDA. Products not initially reported in RES 98601.
FDA DevicesOctopus Evolution AS Tissue Stabilizer, Model TS2500
Octopus Evolution AS Tissue Stabilizer, Model TS2500
During the manufacturing process, Medtronic personnel identified an assembly issue where the tubing was incorrectly positioned. The short tube was attached to the bottom of the canister, and the long tube was attached to the top, contrary to the intended design.
FDA DevicesSurgify Halo, 5.4 mm, Long, Model/Catalog Number: 54.140.SHD.U1; drills, burrs, trephines & accessories (simple, powered)
Surgify Halo, 5.4 mm, Long, Model/Catalog Number: 54.140.SHD.U1; drills, burrs, trephines & accessories (simple, powered)
Potential for burr breakage, occurring during bi-portal endoscopic spinal surgery (BESS).
FDA Foodboichik bagles Pumpernickel Mix Bagels 6 pre-sliced bagels NET WT 26.5 OZ (1.66 LB) 750g Ingredients: Organic wheat flour ... Contains Wheat Topped flavors may additionally contain ... sesame seeds ... Best by SE 26 26 UPC: 850016588067
boichik bagles Pumpernickel Mix Bagels 6 pre-sliced bagels NET WT 26.5 OZ (1.66 LB) 750g Ingredients: Organic wheat flour ... Contains Wheat Topped flavors may additionally contain ... sesame seeds ... Best by SE 26 26 UPC: 850016588067
Undeclared allergen, sesame.
FDA FoodJoy Masala Chaash Lassi 16 oz., 64 oz.
Joy Masala Chaash Lassi 16 oz., 64 oz.
Product not adequately pasteurized
FDA DrugsSensipar (cinacalcet) Tablets, 30mg, 30-count bottles, Rx Only, Distributed by: Amge, One Amgen Center Drive, Thousand Oaks ,CA 91320-1799, Made in Japan. NDC 55513-073-30
Sensipar (cinacalcet) Tablets, 30mg, 30-count bottles, Rx Only, Distributed by: Amge, One Amgen Center Drive, Thousand Oaks ,CA 91320-1799, Made in Japan. NDC 55513-073-30
CGMP Deviations