États-Unis Recalls
Rappels de sécurité de la FDA, CPSC, NHTSA et de l’USDA FSIS.
FDA DevicesBEAR Implant. Model Number: 1000.
BEAR Implant. Model Number: 1000.
Incorrect expiration date on label that extends beyond the product's documented/approved shelf life. With an incorrect expiration date, the UDI will also be incorrect.
FDA FoodBlack Bean Bonanza Tamales with Black Beans and Jack Cheese Ingredients: Organic Corn Flour Masa, Black Beans, Jack Cheese (Pasteurized Milk, Cheese Cultures, Salt, Enzymes), Salsa (Tomatoes, Onions, Chiles, Garlic & Cilantro), Butter, Non-GMO Corn, Salt, Spices, Baking Powder (Sodium Acid Pyrophosphate, Sodium Bicarbonate, Corn Starch and Monocalcium Phosphate). Microwave: In husk approx. 90 seconds per tamale. Steam: In husk approx. 15 minutes. Primavera 17070 Sonoma Hwy. Sonoma, CA 95476 (707) 939-9350 Perishable Keep Refrigerated Net Wt. 24oz. UPC: 748732000218
Black Bean Bonanza Tamales with Black Beans and Jack Cheese Ingredients: Organic Corn Flour Masa, Black Beans, Jack Cheese (Pasteurized Milk, Cheese Cultures, Salt, Enzymes), Salsa (Tomatoes, Onions, Chiles, Garlic & Cilantro), Butter, Non-GMO Corn, Salt, Spices, Baking Powder (Sodium Acid Pyrophosphate, Sodium Bicarbonate, Corn Starch and Monocalcium Phosphate). Microwave: In husk approx. 90 seconds per tamale. Steam: In husk approx. 15 minutes. Primavera 17070 Sonoma Hwy. Sonoma, CA 95476 (707) 939-9350 Perishable Keep Refrigerated Net Wt. 24oz. UPC: 748732000218
Potential contamination with biological hazards (Listeria monocytogenes).
FDA FoodGoldenroot Yuzu Ginger Lemongrass Ginger Beer. 12 oz. (355 ml) UPC 8 50052-32817 7. Keep Cold. Manufactured By Goldenroot, 3841 Market St #113, Denton, TX 76209.
Goldenroot Yuzu Ginger Lemongrass Ginger Beer. 12 oz. (355 ml) UPC 8 50052-32817 7. Keep Cold. Manufactured By Goldenroot, 3841 Market St #113, Denton, TX 76209.
Ginger Beer products might contain ginger juice that did not undergo the required pasteurization process.
FDA Drugsmethylprednisolone tablets, USP Dosepak, 4 mg, 1 Blister Card per Carton containing 21 Tablets, Rx only, Distributed by: Greenstone LLC, Peapack, NJ 07977. NDC 59762-4440-2
methylprednisolone tablets, USP Dosepak, 4 mg, 1 Blister Card per Carton containing 21 Tablets, Rx only, Distributed by: Greenstone LLC, Peapack, NJ 07977. NDC 59762-4440-2
Labeling: Not Elsewhere Classified. Incorrect orientation of the blister foil applied to the blister cavities, which results in incorrect dosing information when following the directions on the foil.
FDA DrugsINON ACE Antacid tablets (magnesium aluminosilicate, magnesium hydroxide and simethicone), 75-count bottle, Manufactured by: Sato Pharmaceutical Co., Ltd., NDC 49873-402-01
INON ACE Antacid tablets (magnesium aluminosilicate, magnesium hydroxide and simethicone), 75-count bottle, Manufactured by: Sato Pharmaceutical Co., Ltd., NDC 49873-402-01
Failed Disintegration Specifications: above the time expected.
FDA DevicesMR 7700. Product Code (REF): (1) 782120, (2) 782153. MR systems with SW version R11.1 and R12.1.
MR 7700. Product Code (REF): (1) 782120, (2) 782153. MR systems with SW version R11.1 and R12.1.
The potential for stiffness value errors when viewing exported MR Elastography (MRE) stiffness maps to viewer Picture Archiving and Communication System (PACS).
FDA FoodGoldenroot Lemon Double Ginger, Ginger Beer. 12 oz. (355 ml) UPC 8 50052-32819 1. Keep Cold. Manufactured By Goldenroot, 3841 Market St #113, Denton, TX 76209.
Goldenroot Lemon Double Ginger, Ginger Beer. 12 oz. (355 ml) UPC 8 50052-32819 1. Keep Cold. Manufactured By Goldenroot, 3841 Market St #113, Denton, TX 76209.
Ginger Beer products might contain ginger juice that did not undergo the required pasteurization process.
FDA FoodMcCafe Premium Roast Decaf Coffee K-Cup Pods, Net Wt. 29 oz (823g), packaged as an 84-count carton, UPC 043000073438. Distributed By: Keurig Green Mountain, Inc. Burlington, MA 01803 U.S.A.
McCafe Premium Roast Decaf Coffee K-Cup Pods, Net Wt. 29 oz (823g), packaged as an 84-count carton, UPC 043000073438. Distributed By: Keurig Green Mountain, Inc. Burlington, MA 01803 U.S.A.
Product is labeled as decaf, but might contain caffeine.
FDA DevicesMedline medical procedure convenience kits labeled as: HEAD SHAVE-LATEX SAFE KIT, Kit SKU P903933B
Medline medical procedure convenience kits labeled as: HEAD SHAVE-LATEX SAFE KIT, Kit SKU P903933B
Medline kits were manufactured and distributed containing MASTISOL liquid adhesive which was recalled due to complaints that the butyrate tubing cracked during actuation of the vials of MASTISOL Liquid Adhesive.
FDA DevicesGenesis Push-In Suture Anchor
Genesis Push-In Suture Anchor
Reports of device failure, including anchor breakage, anchor bending, anchor pull out, suture breakage, and secondary packaging breakage.
FDA DevicesMedline medical procedure convenience kits labeled as: 1) C-SECTION PACK, Kit SKU DYNJ35494C; 2) SMJ C-SECTION PACK-LF, Kit SKU DYNJ38582O; 3) RR-L&D C-SECTION PACK-LF, Kit SKU DYNJ82084F.
Medline medical procedure convenience kits labeled as: 1) C-SECTION PACK, Kit SKU DYNJ35494C; 2) SMJ C-SECTION PACK-LF, Kit SKU DYNJ38582O; 3) RR-L&D C-SECTION PACK-LF, Kit SKU DYNJ82084F.
Medline kits were manufactured and distributed containing MASTISOL liquid adhesive which was recalled due to complaints that the butyrate tubing cracked during actuation of the vials of MASTISOL Liquid Adhesive.
FDA DevicesMedline medical procedure convenience kits labeled as: 1) MEM MAXILLOFACIAL PACK-LF, Kit SKU DYNJ0660040R; 2) PLASTICS VCH, Kit SKU DYNJ39225K; 3) WT BREAST PACK, Kit SKU DYNJ46620I; 4) ENDO / AUG PACK, Kit SKU DYNJ59250I; 5) KMC PLASTIC/GEN PACK-LF, Kit SKU DYNJ65980J; 6) PLASTICS PACK, Kit SKU DYNJ68288A; 7) IMPLANT REMOVAL KIT, Kit SKU MNS13035; 8) PLASTICS PACK-LF, Kit SKU PHS41746D.
Medline medical procedure convenience kits labeled as: 1) MEM MAXILLOFACIAL PACK-LF, Kit SKU DYNJ0660040R; 2) PLASTICS VCH, Kit SKU DYNJ39225K; 3) WT BREAST PACK, Kit SKU DYNJ46620I; 4) ENDO / AUG PACK, Kit SKU DYNJ59250I; 5) KMC PLASTIC/GEN PACK-LF, Kit SKU DYNJ65980J; 6) PLASTICS PACK, Kit SKU DYNJ68288A; 7) IMPLANT REMOVAL KIT, Kit SKU MNS13035; 8) PLASTICS PACK-LF, Kit SKU PHS41746D.
Medline kits were manufactured and distributed containing MASTISOL liquid adhesive which was recalled due to complaints that the butyrate tubing cracked during actuation of the vials of MASTISOL Liquid Adhesive.
NHTSADaimler Coaches North America - Defective Door Control Valve May Prevent Door from Opening
Daimler Coaches North America - Defective Door Control Valve May Prevent Door from Opening
A door that cannot be opened can prevent or delay passengers from evacuating during an emergency, increasing the risk of injury.
FDA DevicesIngenia 3.0T. Product Code (REF): (1) 781342, (2) 781377. MR systems with SW version R11.1 and R12.1.
Ingenia 3.0T. Product Code (REF): (1) 781342, (2) 781377. MR systems with SW version R11.1 and R12.1.
The potential for stiffness value errors when viewing exported MR Elastography (MRE) stiffness maps to viewer Picture Archiving and Communication System (PACS).
FDA DevicesBrand Name: Zimmer Tourniquet Systems Product Name: A.T.S.¿ 5000TS Tourniquet Systems Model/Catalog Number: 60500010100 Software Version: Software version v2.04 or prior are within scope of the recall for A.T.S.¿ 5000TS Product Description: A.T.S 5000TS Tourniquet Systems Component: N/A
Brand Name: Zimmer Tourniquet Systems Product Name: A.T.S.¿ 5000TS Tourniquet Systems Model/Catalog Number: 60500010100 Software Version: Software version v2.04 or prior are within scope of the recall for A.T.S.¿ 5000TS Product Description: A.T.S 5000TS Tourniquet Systems Component: N/A
Device user interface (screen) may freeze or become unresponsive to touch when operating in certain non-English language settings. Issue may cause delay or extension while alternate device is located.
FDA DevicesBrand Name: Broselow Product Name: Broselow Domestic Complete ALS Organizer Model/Catalog Number: 7730ALS Software Version: Not Applicable Product Description: The Broselow Tape is a length- and weight-based reference tool specifically designed for pediatric emergency care. Component: No
Brand Name: Broselow Product Name: Broselow Domestic Complete ALS Organizer Model/Catalog Number: 7730ALS Software Version: Not Applicable Product Description: The Broselow Tape is a length- and weight-based reference tool specifically designed for pediatric emergency care. Component: No
Product contains potentially harmful dosing errors for Vecuronium, Flumazenil, and Ketamine.
FDA DevicesIngenia Ambition X. Product Code (REF): (1) 781356, (2) 782109, (3)782138. MR systems with SW version R11.1 and R12.1.
Ingenia Ambition X. Product Code (REF): (1) 781356, (2) 782109, (3)782138. MR systems with SW version R11.1 and R12.1.
The potential for stiffness value errors when viewing exported MR Elastography (MRE) stiffness maps to viewer Picture Archiving and Communication System (PACS).
FDA DevicesIngenia 1.5T. Product Code (REF): (1) 781341, (2) 781396. MR systems with SW version R11.1 and R12.1.
Ingenia 1.5T. Product Code (REF): (1) 781341, (2) 781396. MR systems with SW version R11.1 and R12.1.
The potential for stiffness value errors when viewing exported MR Elastography (MRE) stiffness maps to viewer Picture Archiving and Communication System (PACS).
FDA DevicesLSL Healthcare, Central Line Dressing Kit, Model/Catalog Number: 2519CP, medical procedure convenience kit
LSL Healthcare, Central Line Dressing Kit, Model/Catalog Number: 2519CP, medical procedure convenience kit
BD ChloraPrep Triple Swabsticks, a component within the kits, exhibit an open seal on the packaging of the applicators.
FDA DevicesFeminine hygiene products, labeled as: KOTEX FREEDOM MAXI NO WINGS 48CT, ALWAYS THIN LINERS UNSCENTED 12 CT, ALWAYS THIN LINERS SCENTED 12CT, ALWAYS ULT.THIN WINGS REG.12/22CT, ALWAYS ULT.THIN OVER NIGHT WINGS 12/16CT, JULIE MAXI NIGHT W.WINGS 36/10CT, STAY FREE REG. 12/10CT, STAY FREE SUPER 24/6CT, TAMPAX REG. 10CT, TAMPAX SUPER 10CT.
Feminine hygiene products, labeled as: KOTEX FREEDOM MAXI NO WINGS 48CT, ALWAYS THIN LINERS UNSCENTED 12 CT, ALWAYS THIN LINERS SCENTED 12CT, ALWAYS ULT.THIN WINGS REG.12/22CT, ALWAYS ULT.THIN OVER NIGHT WINGS 12/16CT, JULIE MAXI NIGHT W.WINGS 36/10CT, STAY FREE REG. 12/10CT, STAY FREE SUPER 24/6CT, TAMPAX REG. 10CT, TAMPAX SUPER 10CT.
Potential exposure of rodents and rodent activity in the distribution center.
FDA DevicesIngenia 3.0T CX. Product Code (REF): 781271. MR systems with SW version R11.1 and R12.1.
Ingenia 3.0T CX. Product Code (REF): 781271. MR systems with SW version R11.1 and R12.1.
The potential for stiffness value errors when viewing exported MR Elastography (MRE) stiffness maps to viewer Picture Archiving and Communication System (PACS).
FDA DevicesEvolution Upgrade 3.0T. Product Code (REF): 782143. MR systems with SW version R11.1 and R12.1.
Evolution Upgrade 3.0T. Product Code (REF): 782143. MR systems with SW version R11.1 and R12.1.
The potential for stiffness value errors when viewing exported MR Elastography (MRE) stiffness maps to viewer Picture Archiving and Communication System (PACS).
FDA DevicesMedline medical procedure convenience kits labeled as: 1) RR-GYN LAPAROSCOPY PACK-LF, Kit SKU DYNJ0395022O; 2) PELVISCOPY PACK-LF, Kit SKU DYNJ0415776Q; 3) DIVA PACK, Kit SKU DYNJ04811O; 4) DA VINCI PROSTATE/COLPOPEXY, Kit SKU DYNJ44864S; 5) MH ROBOTICS PACK, Kit SKU DYNJ50880L; 6) DELNOR LAPAROSCOPIC GYN PACK, Kit SKU DYNJ82244B; 7) ROBOT PACK, Kit SKU DYNJ82761B; 8) GENERAL ROBOTICS PACK, Kit SKU DYNJT4964.
Medline medical procedure convenience kits labeled as: 1) RR-GYN LAPAROSCOPY PACK-LF, Kit SKU DYNJ0395022O; 2) PELVISCOPY PACK-LF, Kit SKU DYNJ0415776Q; 3) DIVA PACK, Kit SKU DYNJ04811O; 4) DA VINCI PROSTATE/COLPOPEXY, Kit SKU DYNJ44864S; 5) MH ROBOTICS PACK, Kit SKU DYNJ50880L; 6) DELNOR LAPAROSCOPIC GYN PACK, Kit SKU DYNJ82244B; 7) ROBOT PACK, Kit SKU DYNJ82761B; 8) GENERAL ROBOTICS PACK, Kit SKU DYNJT4964.
Medline kits were manufactured and distributed containing MASTISOL liquid adhesive which was recalled due to complaints that the butyrate tubing cracked during actuation of the vials of MASTISOL Liquid Adhesive.
FDA DevicesPREGNANCY TEST 24CT
PREGNANCY TEST 24CT
Potential exposure of rodents and rodent activity in the distribution center.