Vereinigte Staaten Recalls
Verbraucherrückrufe von FDA, CPSC, NHTSA und USDA FSIS.
FDA DrugsOndansetron Orally Disintegrating Tablets, USP, 4mg, 30 Tablets (3 blistercards each containing 10 tablets), Rx only, Manufactured for: Glenmark Pharmaceuticals Inc., USA Mahwah, NJ 07430, Product of India, NDC 68462-157-13
Ondansetron Orally Disintegrating Tablets, USP, 4mg, 30 Tablets (3 blistercards each containing 10 tablets), Rx only, Manufactured for: Glenmark Pharmaceuticals Inc., USA Mahwah, NJ 07430, Product of India, NDC 68462-157-13
Defective container: Preferred Pharmaceuticals received a letter from the manufacturer Glenmark, that the blister packs are not fully sealed and tablets falling out. Preferred Pharmaceuticals purchased the finished product and repackaged the product for sale.
FDA DrugstraZODONE Hydrochloride Tablets, USP, 100mg, 1,000 Tablets, Rx only, Manufactured by: Zydus Lifesciences Ltd., India, Distributed by: Zydus Pharmaceuticals (USA) Inc., Pennington, NJ 08534, NDC 68382-806-10
traZODONE Hydrochloride Tablets, USP, 100mg, 1,000 Tablets, Rx only, Manufactured by: Zydus Lifesciences Ltd., India, Distributed by: Zydus Pharmaceuticals (USA) Inc., Pennington, NJ 08534, NDC 68382-806-10
Failed Tablet/Capsule Specifications: Product complaint received that some tablets had a dent on the plain side of the tablet surface.
FDA DevicesBVI Leos Laser and Endoscopy System. Model Number: OME6000U.
BVI Leos Laser and Endoscopy System. Model Number: OME6000U.
Manufacturing deviation in which the ferrites specified for the USB cable assembly linking the Nurse Monitor touchscreen to the System Controller were not installed as intended. The omission of the ferrites on the USB communication cable results in non-conformance to the design specifications, which require two ferrites (one at each end of the cable).
FDA FoodALUMINIUM HAMMERED KADAI SIZE 7 8 901000 000057 MADE IN INDIA
ALUMINIUM HAMMERED KADAI SIZE 7 8 901000 000057 MADE IN INDIA
Potential contamination due to leachable lead.
FDA DevicesPhilips EPIQ Ultrasound Systems (various models) used in conjunction with the X5-1c transducer REF: , , 795200, 795201, 795231, 795232, 795234 REF: 795117, 795122
Philips EPIQ Ultrasound Systems (various models) used in conjunction with the X5-1c transducer REF: , , 795200, 795201, 795231, 795232, 795234 REF: 795117, 795122
Retroactive: Ultrasound may experience an unexpected automatic reboot, resulting in damage to transducer.
FDA DevicesVortex Surgical 25ga Illuminated Flex-Tip Laser Probe, Catalog Number VS0135.25;
Vortex Surgical 25ga Illuminated Flex-Tip Laser Probe, Catalog Number VS0135.25;
Reason for the voluntary recall is some products in this lot are not passing through a 25ga cannula smoothly.
FDA DevicesSheathes3D Seamless Viral Barrier, Latex-Free, 7/8"D Tapered to 2.9"W x 11.8"L (2.2cm Tapered to 7.4cm x 30cm), Non-Sterile, Ultrasound Probe Cover, Vaginal/Rectal, Tapered, Rolled, Extra-Long, Individually Wrapped, Box of 50 Item Number 76339,
Sheathes3D Seamless Viral Barrier, Latex-Free, 7/8"D Tapered to 2.9"W x 11.8"L (2.2cm Tapered to 7.4cm x 30cm), Non-Sterile, Ultrasound Probe Cover, Vaginal/Rectal, Tapered, Rolled, Extra-Long, Individually Wrapped, Box of 50 Item Number 76339,
Vaginal/rectal ultrasound probe covers with a viral barrier may have product defects, which may result in contamination during use, posing an infection risk.
FDA DevicesBrand Name: Mastisol Liquid Adhesive Product Name: Liquid Adhesive Model/Catalog Number: 0523-48 Product Description: Liquid adhesive, 2/3 mL vial, 48 vials per carton Component: No
Brand Name: Mastisol Liquid Adhesive Product Name: Liquid Adhesive Model/Catalog Number: 0523-48 Product Description: Liquid adhesive, 2/3 mL vial, 48 vials per carton Component: No
Butyrate tube cracks during actuation, rendering product unusable.
FDA DevicesMaterial Processing Laser Products
Material Processing Laser Products
Lack of Remote Interlock Connector - required per 21 CFR 1040.10(f)(3)
NHTSAWanli Tire Corporation - Tire Sidewall Separation/FMVSS 139
Wanli Tire Corporation - Tire Sidewall Separation/FMVSS 139
Sidewall separation can cause tire failure, increasing the risk of a crash.
FDA DrugsWegovy (semaglutide) Injection, 1 mg/0.5 mL, 4 Single-Dose Prefilled Pens, Manufactured by: Novo Nordisk A/S, DK-2880 Bagsvaerd, Denmark, Product of Denmark, Novo Nordisk A/S, Novo Nordisk Inc., Plainsboro, NJ 08536, NDC 0169-4501-14
Wegovy (semaglutide) Injection, 1 mg/0.5 mL, 4 Single-Dose Prefilled Pens, Manufactured by: Novo Nordisk A/S, DK-2880 Bagsvaerd, Denmark, Product of Denmark, Novo Nordisk A/S, Novo Nordisk Inc., Plainsboro, NJ 08536, NDC 0169-4501-14
Presence of Particulate Matter: Hair was found in a prefilled syringe
FDA Food1) Paw Patrol Heart-Shaped Gummy Candies, Mixed Fruit, Net Wt. 7 oz (200g), packaged in a cardboard box with heart-shaped top, UPC 805219643846, Distributed by Bendon, Inc. 2) Mickey Mouse Heart-Shaped Gummies, Mixed Fruit, Net Wt. 7 oz (200g), packaged in a cardboard box with heart-shaped top, UPC 805219643853, Distributed by Bendon, Inc. 3) Stitch Heart-Shaped Gummies, Tropical, Net Wt. 7 oz (200g), packaged in a cardboard box with heart-shaped top, UPC 805219643860, Distributed by Bendon, Inc. 4) SpongeBob Squarepants Heart-Shaped Gummy Candy, Tropical, Net Wt. 7 oz (200g), packaged in a cardboard box with heart-shaped top, UPC 805219644225, Distributed by Bendon, Inc. 5) Toy Story Multipack Size Gummies, Mixed Fruit, Net Wt. 6.35 oz (180g), packaged in a plastic bag containing 20 mini size packs (0.4 oz each), UPC 805219643914, Distributed by Bendon, Inc.
1) Paw Patrol Heart-Shaped Gummy Candies, Mixed Fruit, Net Wt. 7 oz (200g), packaged in a cardboard box with heart-shaped top, UPC 805219643846, Distributed by Bendon, Inc. 2) Mickey Mouse Heart-Shaped Gummies, Mixed Fruit, Net Wt. 7 oz (200g), packaged in a cardboard box with heart-shaped top, UPC 805219643853, Distributed by Bendon, Inc. 3) Stitch Heart-Shaped Gummies, Tropical, Net Wt. 7 oz (200g), packaged in a cardboard box with heart-shaped top, UPC 805219643860, Distributed by Bendon, Inc. 4) SpongeBob Squarepants Heart-Shaped Gummy Candy, Tropical, Net Wt. 7 oz (200g), packaged in a cardboard box with heart-shaped top, UPC 805219644225, Distributed by Bendon, Inc. 5) Toy Story Multipack Size Gummies, Mixed Fruit, Net Wt. 6.35 oz (180g), packaged in a plastic bag containing 20 mini size packs (0.4 oz each), UPC 805219643914, Distributed by Bendon, Inc.
Unapproved color additive - chlorophyllin copper complex
NHTSABlue Bird Body Company - Wheelchair Restraint Retractor May Not Lock
Blue Bird Body Company - Wheelchair Restraint Retractor May Not Lock
An unsecured wheelchair can move during transit, increasing the risk of injury.
NHTSAAllwin Powersports Corp. - Helmets May Not Adequately Protect User/FMVSS 218
Allwin Powersports Corp. - Helmets May Not Adequately Protect User/FMVSS 218
A helmet that does not provide adequate protection increases the risk of injury during a crash.
NHTSARivian Automotive, LLC - Toe Link Joint May Separate
Rivian Automotive, LLC - Toe Link Joint May Separate
The toe link joint may separate, increasing the risk of a crash.
NHTSABlue Bird Body Company - Loose 12-Volt Cable May Cause Loss Of Drive Power and Electrical System
Blue Bird Body Company - Loose 12-Volt Cable May Cause Loss Of Drive Power and Electrical System
A loss of brake assist, drive power, steering assist, or instrument panel displays can increase the risk of a crash.
NHTSAVolvo Car USA, LLC - Park Outside - High Voltage Battery Fire Risk
Volvo Car USA, LLC - Park Outside - High Voltage Battery Fire Risk
A high-voltage battery that overheats increases the risk of a fire.
NHTSABraun Industries, Inc. - Electrical Systems May Fail
Braun Industries, Inc. - Electrical Systems May Fail
A loss of exterior lights can reduce the visibility of the vehicle to other drivers, increasing the risk of a crash. A loss of patient support systems can delay care, increasing the risk of injury.
NHTSAGillig, LLC - Improperly Tightened Rear Axle Upper Torque Rod Fasteners
Gillig, LLC - Improperly Tightened Rear Axle Upper Torque Rod Fasteners
Damaged axle components can decrease stability or vehicle control, increasing the risk of a crash.
USDA FSISMountain West Food Group, LLC Recalls Ground Beef Products Due To Possible E. Coli O26 Contamination
Mountain West Food Group, LLC Recalls Ground Beef Products Due To Possible E. Coli O26 Contamination
Product Contamination
NHTSAEvenflo Company, Inc. - Recline Position May Shift/FMVSS 213
Evenflo Company, Inc. - Recline Position May Shift/FMVSS 213
A child seat that does not maintain proper recline position may not adequately secure a child in a crash, increasing the risk of injury. Additionally, should another passenger put their hand in the recline mechanism when it shifts out of position, their risk of injury is increased.
NHTSANissan North America, Inc. - Incorrect Spare Tire Installed/FMVSS 110
Nissan North America, Inc. - Incorrect Spare Tire Installed/FMVSS 110
Incorrect spare tire pressure information on the placard may lead to incorrect inflation of the spare tire, increasing the risk of a crash.
NHTSAVolvo Car USA, LLC - Rearview Camera Image May Not Display/FMVSS 111
Volvo Car USA, LLC - Rearview Camera Image May Not Display/FMVSS 111
A rearview camera image that does not display reduces the driver's view behind the vehicle, increasing the risk of a crash.
NHTSATiffin Motorhomes, Inc. - Wire May Overheat Between Battery and Inverter
Tiffin Motorhomes, Inc. - Wire May Overheat Between Battery and Inverter
An undersized wire can overheat, increasing the risk of a fire.