États-Unis Recalls
Rappels de sécurité de la FDA, CPSC, NHTSA et de l’USDA FSIS.
Showing 24 of 17,563 results
Medical Device
FDA Devices
FDA DevicesProduct Name: Disposable Triple Lumen Sphincterotome Model/Catalog Number: KD-401Q-0720 Product Description: These instruments have been designed to be used with an Olympus endoscope and guidewire for papillotomy using high-frequency current.
Olympus Corporation of the Americas
FDA DevicesClass II
Product Name: Disposable Triple Lumen Sphincterotome Model/Catalog Number: KD-401Q-0720 Product Description: These instruments have been designed to be used with an Olympus endoscope and guidewire for papillotomy using high-frequency current.
Devices which did not undergo thermoforming could deform and lose performance.
Feb 11, 2026Olympus Corporation of the Americas
Medical DeviceFDA Devices
FDA DevicesProduct Name: Lumipulse G pTau217/B-Amyloid 1-42 Plasma Ratio Model/Catalog Number: CL0073 Software Version: Not Applicable Product Description: Lumipulse G pTau217/¿-Amyloid 1-42 Plasma Ratio is an in vitro diagnostic (IVD) test that combines the test results of the Lumipulse G pTau 217 Plasma assay and the Lumipulse G ¿-Amyloid 1-42-N Plasma assay from the same patient specimen (K2EDTA plasma sample) into a numerical ratio. The Lumipulse G pTau 217/¿-Amyloid 1-42 Plasma Ratio Instructions For Use (IFU), CL0072, contains instructions on how to manually calculate the ratio and is supplied with each individual Lumipulse G assay. Lumipulse G pTau217/¿-Amyloid 1-42 Plasma Ratio, Item# CL0073 is comprised of the following kits, which are imported: Kit Description, Item#: Imported from Fujirebio Europe (FRE): Lumipulse G pTau 217 Plasma Immunoreaction Cartridges 81550 Lumipulse G pTau 217 Plasma Calibrators set 81557 Lumipulse pTau 217 Plasma Controls 81558 Lumipulse ¿-Amyloid Plasma Controls 81559 Imported from Fujirebio Japan (FRI): Lumipulse G ¿-Amyloid 1-42-N Plasma Immunoreaction Cartridges 235447 Lumipulse G ¿-Amyloid 1-42-N Plasma Calibrators set 235454 Component: No
Fujirebio Diagnostics, Inc.
FDA DevicesClass II
Product Name: Lumipulse G pTau217/B-Amyloid 1-42 Plasma Ratio Model/Catalog Number: CL0073 Software Version: Not Applicable Product Description: Lumipulse G pTau217/¿-Amyloid 1-42 Plasma Ratio is an in vitro diagnostic (IVD) test that combines the test results of the Lumipulse G pTau 217 Plasma assay and the Lumipulse G ¿-Amyloid 1-42-N Plasma assay from the same patient specimen (K2EDTA plasma sample) into a numerical ratio. The Lumipulse G pTau 217/¿-Amyloid 1-42 Plasma Ratio Instructions For Use (IFU), CL0072, contains instructions on how to manually calculate the ratio and is supplied with each individual Lumipulse G assay. Lumipulse G pTau217/¿-Amyloid 1-42 Plasma Ratio, Item# CL0073 is comprised of the following kits, which are imported: Kit Description, Item#: Imported from Fujirebio Europe (FRE): Lumipulse G pTau 217 Plasma Immunoreaction Cartridges 81550 Lumipulse G pTau 217 Plasma Calibrators set 81557 Lumipulse pTau 217 Plasma Controls 81558 Lumipulse ¿-Amyloid Plasma Controls 81559 Imported from Fujirebio Japan (FRI): Lumipulse G ¿-Amyloid 1-42-N Plasma Immunoreaction Cartridges 235447 Lumipulse G ¿-Amyloid 1-42-N Plasma Calibrators set 235454 Component: No
Customers may experience inaccurate test results by observing a higher frequency of classification in the indeterminate and positive zone and/or low specificity when compared back to FDA-cleared CSF ratio/PET imaging, due to falsely elevated positive ratio or falsely elevated indeterminate ratio results causing an incorrect classification of a patient as having amyloid pathology associated with Alzheimer s disease (positive result) and/or requiring more clinical testing of that patient (indeterminate result).
Feb 11, 2026Fujirebio Diagnostics, Inc.
Medical DeviceFDA Devices
FDA DevicesProduct Name: Nasal Jejunal Feeding Tube REF: NJFT-10
Wilson-Cook Medical Inc.
FDA DevicesClass II
Product Name: Nasal Jejunal Feeding Tube REF: NJFT-10
Nasal feeding tube packaged without the nasal transfer tube component.
Feb 11, 2026Wilson-Cook Medical Inc.
Food & BeverageFDA Food
FDA FoodBarbaCuban 90 Miles to Mojo Marinade, Net Wt 12 oz (355 ml) 12 oz glass bottles,1 gallon HDPE Industrial Plastic Jugs, ¿ gallon HDPE Industrial Plastic Jugs. packaged in 12x12 fl oz, 6x12 fl oz, 4x1 gallon, 4x1/2 gallons. UPC code 7 19660 00096 0
Prima Foods International, Inc.
FDA FoodClass III
BarbaCuban 90 Miles to Mojo Marinade, Net Wt 12 oz (355 ml) 12 oz glass bottles,1 gallon HDPE Industrial Plastic Jugs, ¿ gallon HDPE Industrial Plastic Jugs. packaged in 12x12 fl oz, 6x12 fl oz, 4x1 gallon, 4x1/2 gallons. UPC code 7 19660 00096 0
Undeclared Quinine
Feb 11, 2026Prima Foods International, Inc.
Medical DeviceFDA Devices
FDA DevicesTORNIER PERFORM REVERSED PERIP SCREW 5.0MMX18MM NON STERILE, catalog number DWJ318
Tornier, Inc
FDA DevicesClass II
TORNIER PERFORM REVERSED PERIP SCREW 5.0MMX18MM NON STERILE, catalog number DWJ318
A specific lot of screws is incorrectly labeled. Screws are labeled as 5.0mmx18mm but actual screws are 5.00mmx14mm. If mismatch is detected during surgery, the issue may cause a minor delay in surgery. If not detected and incorrect screw is used, issue may increase risk of earlier mechanical failure, loosening, and need for revision surgery.
Feb 11, 2026Tornier, Inc
Medical DeviceFDA Devices
FDA DevicesFocalyx Fusion
Focalyx Technologies, LLC.
FDA DevicesClass II
Focalyx Fusion
Software device that is an accessory for image-guided interventional and diagnostic procedures involving prostate has accessories that may not function properly with Windows 10, which may cause patient harm during biopsy or cause treatment/therapy delays, so firm is recommending stop use until device is verified/validated with Windows 11.
Feb 11, 2026Focalyx Technologies, LLC.
Medical DeviceFDA Devices
FDA DevicesVortex Disposable Forceps and Cannula 1. 23GA ACTU8 Forceps Adaptive VS0740.23 2. 25GA ACTU8 Forceps Adaptive VS0740.25 3. 25GA ACTU8 Forceps ILM VS0744.25 4. 25GA ACTU8 Forceps ILM -Myopic VS0744.25-35 5. 25GA ACTU8 Forceps Pro-Grip VS0713.25 6. 25GA ACTU8 Talon Forceps ILM VS0752.25 7. 25GA ACTU8 Talon Forceps Pro-Grip VS0751.25 8. 27GA ACTU8 Forceps ILM VS0744.27 9. 23GA Soft Tip Cannula VS0200.23 10. 23GA Soft Tip Cannula - 0.5mm VS0205.23 11. 25GA Soft Tip Cannula VS0200.25 12. 25GA Soft Tip Cannula - 0.5mm VS0205.25 13. 25GA Soft Tip Cannula - 0.5mm - Bulk VS0205.25B 14. 25GA Soft Tip Cannula-Bulk VS0200.25B 15. 27GA Soft Tip Cannula VS0200.27
Vortex Surgical Inc.
FDA DevicesClass II
Vortex Disposable Forceps and Cannula 1. 23GA ACTU8 Forceps Adaptive VS0740.23 2. 25GA ACTU8 Forceps Adaptive VS0740.25 3. 25GA ACTU8 Forceps ILM VS0744.25 4. 25GA ACTU8 Forceps ILM -Myopic VS0744.25-35 5. 25GA ACTU8 Forceps Pro-Grip VS0713.25 6. 25GA ACTU8 Talon Forceps ILM VS0752.25 7. 25GA ACTU8 Talon Forceps Pro-Grip VS0751.25 8. 27GA ACTU8 Forceps ILM VS0744.27 9. 23GA Soft Tip Cannula VS0200.23 10. 23GA Soft Tip Cannula - 0.5mm VS0205.23 11. 25GA Soft Tip Cannula VS0200.25 12. 25GA Soft Tip Cannula - 0.5mm VS0205.25 13. 25GA Soft Tip Cannula - 0.5mm - Bulk VS0205.25B 14. 25GA Soft Tip Cannula-Bulk VS0200.25B 15. 27GA Soft Tip Cannula VS0200.27
There may be voids located in the seal of Tyvek pouches associated with identified catalog numbers and lots. A compromised sterile barrier has potential of bioburden contamination which could lead to infection.
Feb 11, 2026Vortex Surgical Inc.
Food & BeverageFDA Food
FDA FoodWilly Pete's Chocolates brand Almond Despair; Dark Chocolate with Coconuts, Almonds, & Carolina Reapers; Ingredients: Sugar, Vegetable Oil, (Palm Kernel Oil & Hydrogentated Palm Kernel Oil), Cocoa Powder (processed with Alkali), Soy Lecithin (An Emulsifier), Whey Powder (Milk) & Salt. Coconut, Sugar, Water Propylene Glycol (Sustains Freshness), Salt, Sodium Metabisulfite (Preserves Whiteness). Macadamia nuts & Carolina Reaper Powder; Contains Milk and Soy. Tree Nuts. May contain traces of peanuts; UPC: 0 987261 5
Willy Pete's Chocolate Company LLC
FDA FoodClass III
Willy Pete's Chocolates brand Almond Despair; Dark Chocolate with Coconuts, Almonds, & Carolina Reapers; Ingredients: Sugar, Vegetable Oil, (Palm Kernel Oil & Hydrogentated Palm Kernel Oil), Cocoa Powder (processed with Alkali), Soy Lecithin (An Emulsifier), Whey Powder (Milk) & Salt. Coconut, Sugar, Water Propylene Glycol (Sustains Freshness), Salt, Sodium Metabisulfite (Preserves Whiteness). Macadamia nuts & Carolina Reaper Powder; Contains Milk and Soy. Tree Nuts. May contain traces of peanuts; UPC: 0 987261 5
Almonds are not declared in the ingredient statement. Almond is included in description of product on front label.
Feb 11, 2026Willy Pete's Chocolate Company LLC
Food & BeverageFDA Food
FDA FoodJUICE from the Raw, cashew milk
Everpress Juice
FDA FoodClass I
JUICE from the Raw, cashew milk
Under-processed product may contain pathogenic bacteria that could harm to humans.
Feb 11, 2026Everpress Juice
Medical DeviceFDA Devices
FDA DevicesOertli 1. 23G Laser Probe OS4 Flex-Tip VK401113 2. 23G Laser Probe OS4 Illuminated Flex-Tip VK401213 3. 23G Laser Probe OS4 Intuitive Exendable VK401323 4. 25G Laser Probe OS4 Flex-Tip VK401115 5. 25G Laser Probe OS4 Illuminated Flex-Tip VK401215 6. 25G Laser Probe OS4 Intuitive Exendable VK401325 7. 27G Laser Probe OS4 Intuitive Exendable VK401327
Vortex Surgical Inc.
FDA DevicesClass II
Oertli 1. 23G Laser Probe OS4 Flex-Tip VK401113 2. 23G Laser Probe OS4 Illuminated Flex-Tip VK401213 3. 23G Laser Probe OS4 Intuitive Exendable VK401323 4. 25G Laser Probe OS4 Flex-Tip VK401115 5. 25G Laser Probe OS4 Illuminated Flex-Tip VK401215 6. 25G Laser Probe OS4 Intuitive Exendable VK401325 7. 27G Laser Probe OS4 Intuitive Exendable VK401327
There may be voids located in the seal of Tyvek pouches associated with identified catalog numbers and lots. A compromised sterile barrier has potential of bioburden contamination which could lead to infection.
Feb 11, 2026Vortex Surgical Inc.
Medical DeviceFDA Devices
FDA DevicesVortex Surgical 25GA Backflush, VS0270.25; 25GA Backflush Retractable, VS0275.27
Vortex Surgical Inc.
FDA DevicesClass II
Vortex Surgical 25GA Backflush, VS0270.25; 25GA Backflush Retractable, VS0275.27
There may be voids located in the seal of Tyvek pouches associated with identified catalog numbers and lots. A compromised sterile barrier has potential of bioburden contamination which could lead to infection.
Feb 11, 2026Vortex Surgical Inc.
Food & BeverageFDA Food
FDA FoodSofit, Seedless Red Dates, 12 oz package, Plastic bags, 50 packages per case
Tai Phat Wholesalers, LLC
FDA FoodClass I
Sofit, Seedless Red Dates, 12 oz package, Plastic bags, 50 packages per case
Undeclared sulfites
Feb 11, 2026Tai Phat Wholesalers, LLC
PharmaceuticalFDA Drugs
FDA DrugsGreen Lumber Natural Fuel For Men capsule, packaged in 2, 4, 10, and 30-count blister packs. GreenLumber.com, 2618 San Miguel Drive, Suite #296, Newport Beach, CA 92660
Green Lumber Holdings, LLC
FDA DrugsClass I
Green Lumber Natural Fuel For Men capsule, packaged in 2, 4, 10, and 30-count blister packs. GreenLumber.com, 2618 San Miguel Drive, Suite #296, Newport Beach, CA 92660
Marketed without an Approved NDA/ANDA: FDA analysis found this product to contain tadalafil
Feb 11, 2026Green Lumber Holdings, LLC
Vehicle RecallNHTSA
NHTSATriumph Motorcycles America, Ltd. - Alternator Wiring May Short and Overheat
Triumph Motorcycles America, Ltd.
NHTSAELECTRICAL SYSTEM
Triumph Motorcycles America, Ltd. - Alternator Wiring May Short and Overheat
Overheated wiring increases the risk of a crash or fire.
Feb 11, 2026Triumph Motorcycles America, Ltd.
Vehicle RecallNHTSA
NHTSAGeneral Rubber (Thailand) Co., Ltd - Tires May Crack and Separate/FMVSS 139
General Rubber (Thailand) Co., Ltd
NHTSAGeneral Alert
General Rubber (Thailand) Co., Ltd - Tires May Crack and Separate/FMVSS 139
Tire failure can cause a sudden loss of tire pressure, increasing the risk of a crash.
Feb 11, 2026General Rubber (Thailand) Co., Ltd
Food & BeverageFDA Food
FDA FoodJUICE from the Raw, cashew coffee milk
Everpress Juice
FDA FoodClass I
JUICE from the Raw, cashew coffee milk
Under-processed product may contain pathogenic bacteria that could harm to humans.
Feb 11, 2026Everpress Juice
Medical DeviceFDA Devices
FDA DevicesProduct Name: Single Use 3-Lumen Sphincterotome V (Distal Wire guided) Model/Catalog Number: KD-VC411Q-0725; Software Version: N/A Product Description: These instruments have been designed to be used with an Olympus endoscope and guidewire for papillotomy using high-frequency current.
Olympus Corporation of the Americas
FDA DevicesClass II
Product Name: Single Use 3-Lumen Sphincterotome V (Distal Wire guided) Model/Catalog Number: KD-VC411Q-0725; Software Version: N/A Product Description: These instruments have been designed to be used with an Olympus endoscope and guidewire for papillotomy using high-frequency current.
Devices which did not undergo thermoforming could deform and lose performance.
Feb 11, 2026Olympus Corporation of the Americas
Medical DeviceFDA Devices
FDA DevicesProduct Name: Single Use 3-Lumen Sphincterotome V (Distal Wire guided) Model/Catalog Number: KD-VC412Q-0215; Software Version: N/A Product Description: These instruments have been designed to be used with an Olympus endoscope and guidewire for papillotomy using high-frequency current.
Olympus Corporation of the Americas
FDA DevicesClass II
Product Name: Single Use 3-Lumen Sphincterotome V (Distal Wire guided) Model/Catalog Number: KD-VC412Q-0215; Software Version: N/A Product Description: These instruments have been designed to be used with an Olympus endoscope and guidewire for papillotomy using high-frequency current.
Devices which did not undergo thermoforming could deform and lose performance.
Feb 11, 2026Olympus Corporation of the Americas
Medical DeviceFDA Devices
FDA DevicesProduct Name: Single Use Sphincterotome V (Distal Wire guided) Model/Catalog Number: KD-VC431Q-0720 Product Description: These instruments have been designed to be used with an Olympus endoscope and guidewire for papillotomy using high-frequency current.
Olympus Corporation of the Americas
FDA DevicesClass II
Product Name: Single Use Sphincterotome V (Distal Wire guided) Model/Catalog Number: KD-VC431Q-0720 Product Description: These instruments have been designed to be used with an Olympus endoscope and guidewire for papillotomy using high-frequency current.
Devices which did not undergo thermoforming could deform and lose performance.
Feb 11, 2026Olympus Corporation of the Americas
Medical DeviceFDA Devices
FDA DevicesProduct Name: Single Use 3-Lumen Sphincterotome V Model/Catalog Number: KD-V411M-1530 Product Description: These instruments have been designed to be used with an Olympus endoscope and guidewire for papillotomy using high-frequency current.
Olympus Corporation of the Americas
FDA DevicesClass II
Product Name: Single Use 3-Lumen Sphincterotome V Model/Catalog Number: KD-V411M-1530 Product Description: These instruments have been designed to be used with an Olympus endoscope and guidewire for papillotomy using high-frequency current.
Devices which did not undergo thermoforming could deform and lose performance.
Feb 11, 2026Olympus Corporation of the Americas
Vehicle RecallNHTSA
NHTSADaimler Trucks North America, LLC - Improper Battery Connection May Cause Fire
Daimler Trucks North America, LLC
NHTSAELECTRICAL SYSTEM
Daimler Trucks North America, LLC - Improper Battery Connection May Cause Fire
A short circuit increases the risk of a fire.
Feb 11, 2026Daimler Trucks North America, LLC
Medical DeviceFDA Devices
FDA DevicesBrand Name: CleverCut Product Name: Single Use 3-Lumen Sphincterotome V Model/Catalog Number: KD-V411M-0320; Software Version: N/A Product Description: These instruments have been designed to be used with an Olympus endoscope and guidewire for papillotomy using high-frequency current.
Olympus Corporation of the Americas
FDA DevicesClass II
Brand Name: CleverCut Product Name: Single Use 3-Lumen Sphincterotome V Model/Catalog Number: KD-V411M-0320; Software Version: N/A Product Description: These instruments have been designed to be used with an Olympus endoscope and guidewire for papillotomy using high-frequency current.
Devices which did not undergo thermoforming could deform and lose performance.
Feb 11, 2026Olympus Corporation of the Americas
Medical DeviceFDA Devices
FDA DevicesProduct Name: Single Use 3-Lumen Sphincterotome V (Distal Wire guided) Model/Catalog Number: KD-VC411Q-0330; Software Version: N/A Product Description: These instruments have been designed to be used with an Olympus endoscope and guidewire for papillotomy using high-frequency current.
Olympus Corporation of the Americas
FDA DevicesClass II
Product Name: Single Use 3-Lumen Sphincterotome V (Distal Wire guided) Model/Catalog Number: KD-VC411Q-0330; Software Version: N/A Product Description: These instruments have been designed to be used with an Olympus endoscope and guidewire for papillotomy using high-frequency current.
Devices which did not undergo thermoforming could deform and lose performance.
Feb 11, 2026Olympus Corporation of the Americas
Food & BeverageFDA Food
FDA FoodWinCo Foods Deli Margherita Pizza Thin Crust, Item #67279. Net wt. 17oz. UPC 0267279 807987. Product is Take & Bake and sold refrigerated in a plastic flexible film as a single retail unit with a 5 day Sell-By date. Distributed by WinCo Foods 650 N. Armstrong Pl. Boise, ID.
WinCo Foods LLC
FDA FoodClass II
WinCo Foods Deli Margherita Pizza Thin Crust, Item #67279. Net wt. 17oz. UPC 0267279 807987. Product is Take & Bake and sold refrigerated in a plastic flexible film as a single retail unit with a 5 day Sell-By date. Distributed by WinCo Foods 650 N. Armstrong Pl. Boise, ID.
Product may contain foreign material (metal fragments).
Feb 11, 2026WinCo Foods LLC