Vereinigte Staaten Recalls

Verbraucherrückrufe von FDA, CPSC, NHTSA und USDA FSIS.

Showing 24 of 17,563 results
Medical DeviceUSFDA Devices

Product 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.
Medical DeviceUSFDA Devices

Product Name: Disposable Triple Lumen Sphincterotome Model/Catalog Number: KD-411Q-0730 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-411Q-0730 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 DeviceUSFDA Devices

Product Name: Single Use 3-Lumen Sphincterotome V (Distal Wire guided) Model/Catalog Number: KD-VC411Q-0720; 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-0720; 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 & BeverageUSFDA Food

BarbaCuban Cubama White Truffle Sauce, Net Wt. 12 oz (355 ml). Packed in 12 oz glass bottles and 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 00190 5

Prima Foods International, Inc.
FDA FoodClass III

BarbaCuban Cubama White Truffle Sauce, Net Wt. 12 oz (355 ml). Packed in 12 oz glass bottles and 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 00190 5

Undeclared Quinine

Feb 11, 2026Prima Foods International, Inc.
Medical DeviceUSFDA Devices

Product Name: Single Use 3-Lumen Sphincterotome V Model/Catalog Number: KD-V411M-3025 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-3025 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 DeviceUSFDA Devices

Male Fertility Sperm Test for Home Use (Cassette)

Changchun Wancheng Bio-Electron Co., Ltd.
FDA DevicesClass II

Male Fertility Sperm Test for Home Use (Cassette)

Test strips and other tests including for near-patient testing, that require a 510(k) were distributed before they could be legally marketed to U.S. customers; devices may cause false or inaccurate diagnostic result by lay person and lead to inappropriate medical intervention.

Feb 11, 2026Changchun Wancheng Bio-Electron Co., Ltd.
Medical DeviceUSFDA Devices

FDR Visionary Suite; Model Number: CH-200; Version: (1) 566-16130-23, (2) 566-16130-31, (3)

FUJIFILM Healthcare Americas Corporation
FDA DevicesClass II

FDR Visionary Suite; Model Number: CH-200; Version: (1) 566-16130-23, (2) 566-16130-31, (3)

It was found that the contacts of the electromagnetic contactors used inside the cabinet of the X-ray high-voltage generator were welded, and the current might continue to be supplied to the power supply circuit even if the power of the device is cut off. As a result, it cannot be denied that the circuit in question overheats and damages the surrounding parts. It may also cause smoke.

Feb 11, 2026FUJIFILM Healthcare Americas Corporation
Medical DeviceUSFDA Devices

Product Name: Single Use 3-Lumen Sphincterotome V Model/Catalog Number: KD-V431M-0720; 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 Model/Catalog Number: KD-V431M-0720; 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 & BeverageUSFDA Food

Sea Moss Gel Superfood; 16 FL OZ; Glass jar sold individually. Mango- UPC# 5065006235875

Diva Fam Inc
FDA FoodClass II

Sea Moss Gel Superfood; 16 FL OZ; Glass jar sold individually. Mango- UPC# 5065006235875

potential Clostridium botulinum contamination

Feb 11, 2026Diva Fam Inc
Food & BeverageUSFDA Food

GLUTEN FREE 14" SEASONED VEGAN PIZZA CRUST; INGREDIENTS: WATER, RICE FLOUR, POTATO STARCH, RICE STARCH, TAPIOCA STARCH, CANE SUGAR, MODIFIED RICE STARCH, POTATO FLOUR, PEA FIBER, CONTAINS LESS THAN 2% OF THE FOLLOWING: CANOLA OIL, YEAST, SALT, CELLULOSE GEL, EXTRA VIRGIN OLIVE OIL, GARLIC POWDER, SPICES, XANTHAN GUM, CELLULOSE GUM, CULTURED BROW RICE, BROWN RICE FLOUR, CITRIC ACID, LACTIC ACID; MAY CONTAIN MILK AND EGGS; MANUFACTURED BY VENCE BAKERY; Net Case Wt: 14 LB 6 OZ (6.52 KG); Unit Net Wt: 11.5 OZ (326 G); COUNT: 20; KEEP FROZEN; GTIN code on shipper case (01) 0 0859955 00412 6

Rich Products Corp
FDA FoodClass II

GLUTEN FREE 14" SEASONED VEGAN PIZZA CRUST; INGREDIENTS: WATER, RICE FLOUR, POTATO STARCH, RICE STARCH, TAPIOCA STARCH, CANE SUGAR, MODIFIED RICE STARCH, POTATO FLOUR, PEA FIBER, CONTAINS LESS THAN 2% OF THE FOLLOWING: CANOLA OIL, YEAST, SALT, CELLULOSE GEL, EXTRA VIRGIN OLIVE OIL, GARLIC POWDER, SPICES, XANTHAN GUM, CELLULOSE GUM, CULTURED BROW RICE, BROWN RICE FLOUR, CITRIC ACID, LACTIC ACID; MAY CONTAIN MILK AND EGGS; MANUFACTURED BY VENCE BAKERY; Net Case Wt: 14 LB 6 OZ (6.52 KG); Unit Net Wt: 11.5 OZ (326 G); COUNT: 20; KEEP FROZEN; GTIN code on shipper case (01) 0 0859955 00412 6

Product contains undeclared milk and egg

Feb 11, 2026Rich Products Corp
Medical DeviceUSFDA Devices

Volk Single Use Vitrectomy Lenses 1. Flat Vitrectomy Lens, Catalog VFD 2. Volk Magnifying Lens, Catalog VMD

Vortex Surgical Inc.
FDA DevicesClass II

Volk Single Use Vitrectomy Lenses 1. Flat Vitrectomy Lens, Catalog VFD 2. Volk Magnifying Lens, Catalog VMD

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 & BeverageUSFDA Food

BarbaCuban Ram Air Red Zesty Ketchup, Net Wt. 12 oz (355 ml) 12 oz glass bottles, and 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 0 07196 60000 7

Prima Foods International, Inc.
FDA FoodClass III

BarbaCuban Ram Air Red Zesty Ketchup, Net Wt. 12 oz (355 ml) 12 oz glass bottles, and 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 0 07196 60000 7

Undeclared Quinine

Feb 11, 2026Prima Foods International, Inc.
Food & BeverageUSFDA Food

Repackaged M&Ms Peanut candies, Net Wt 1.3 oz. Item BB471BG. Labeled as Make Your Mark. For nutrition facts information and ingredients, go to https://hpgbrands.com/sugarspot-nutrition/

Beacon Promotions Inc
FDA FoodClass II

Repackaged M&Ms Peanut candies, Net Wt 1.3 oz. Item BB471BG. Labeled as Make Your Mark. For nutrition facts information and ingredients, go to https://hpgbrands.com/sugarspot-nutrition/

Undeclared allergens (milk, soy, and peanut)

Feb 11, 2026Beacon Promotions Inc
Food & BeverageUSFDA Food

Lost and Found Energy, Sour Gummy Bear, 12pck, 16oz Cans Case UPC: 850075595655 Can UPC: 850075595662 Aluminum Can Packaged

Fazt & Loud LLC
FDA FoodClass III

Lost and Found Energy, Sour Gummy Bear, 12pck, 16oz Cans Case UPC: 850075595655 Can UPC: 850075595662 Aluminum Can Packaged

Recall is due to a misprint on the label that incorrectly identifies the total caffeine content on the can. The item contains 300mg of caffeine, instead of 150mg as provided on the can.

Feb 11, 2026Fazt & Loud LLC
Food & BeverageUSFDA Food

Sea Moss Gel Superfood; 16 FL OZ; Glass jar sold individually. Cherry- UPC# 5061033691264

Diva Fam Inc
FDA FoodClass II

Sea Moss Gel Superfood; 16 FL OZ; Glass jar sold individually. Cherry- UPC# 5061033691264

potential Clostridium botulinum contamination

Feb 11, 2026Diva Fam Inc
Medical DeviceUSFDA Devices

*HOT AXIOS Stent and Electrocautery-Enhanced Delivery System 20mm x 10mm; Material Number (UPN): M00553560;

Boston Scientific Corporation
FDA DevicesClass I

*HOT AXIOS Stent and Electrocautery-Enhanced Delivery System 20mm x 10mm; Material Number (UPN): M00553560;

Increased reports of stent deployment and expansion issues. The most common outcome reasonably foreseeable resulting from difficulty deploying the stent is prolongation of the procedure to exchange the device for a new one. The most serious reasonably foreseeable outcome in cases where the first flange is unable to deploy or expand would be a cascade of events resulting in additional intervention, either endoscopic or surgical, to remove the stent and close the puncture site.

Feb 11, 2026Boston Scientific Corporation
Food & BeverageUSFDA Food

Sea Moss Gel Superfood; 16 FL OZ; Glass jar sold individually. Apple and Cinnamon- UPC# 5065006235776

Diva Fam Inc
FDA FoodClass II

Sea Moss Gel Superfood; 16 FL OZ; Glass jar sold individually. Apple and Cinnamon- UPC# 5065006235776

potential Clostridium botulinum contamination

Feb 11, 2026Diva Fam Inc
Food & BeverageUSFDA Food

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.

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
Food & BeverageUSFDA Food

spicely ORGANIC celery salt NO ARTIFICIAL COLORING NO GLUTEN - NO MSG - NO SOY NO PRESERVATIVES - NO WHEAT NO SUGAR - NO SALT - NO IRRADIATION Net wt: 2.4oz (68g) Ingredients: Salt, *Celery Seeds *Organic www.spicely.com Organic Spices Inc, Fremont CA 94538 UPC: 826998007605

Organic Spices, Inc
FDA FoodClass II

spicely ORGANIC celery salt NO ARTIFICIAL COLORING NO GLUTEN - NO MSG - NO SOY NO PRESERVATIVES - NO WHEAT NO SUGAR - NO SALT - NO IRRADIATION Net wt: 2.4oz (68g) Ingredients: Salt, *Celery Seeds *Organic www.spicely.com Organic Spices Inc, Fremont CA 94538 UPC: 826998007605

Product contains salt and is mislabeled

Feb 11, 2026Organic Spices, Inc
Medical DeviceUSFDA Devices

EMPOWR Acetabular System: Liner, 10 degree Hooded, HXe+, 36H, REF: 942-01-36H; Liner, 10 degree Hooded, HXe+, 36J, REF: 942-01-36J; Liner, 10 degree Hooded, HXe+, 40G, REF: 942-01-40G; Liner, 10 degree Hooded, HXe+, 32C, REF: 942-01-32C

Encore Medical, LP
FDA DevicesClass II

EMPOWR Acetabular System: Liner, 10 degree Hooded, HXe+, 36H, REF: 942-01-36H; Liner, 10 degree Hooded, HXe+, 36J, REF: 942-01-36J; Liner, 10 degree Hooded, HXe+, 40G, REF: 942-01-40G; Liner, 10 degree Hooded, HXe+, 32C, REF: 942-01-32C

942-01-40G acetabular system package was found to contain 942-01-36H acetabular system; and several other acetabular system and knee insert devices may also have a packaging discrepancy, which may cause surgical delay to exchange devices or revision surgery.

Feb 11, 2026Encore Medical, LP
Food & BeverageUSFDA Food

JUICE from the Raw, pineapple mint

Everpress Juice
FDA FoodClass I

JUICE from the Raw, pineapple mint

Under-processed product may contain pathogenic bacteria that could harm to humans.

Feb 11, 2026Everpress Juice
Medical DeviceUSFDA Devices

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

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.
Food & BeverageUSFDA Food

BarbaCuban 455 Everything Sauce (Original), Net Wt 12 oz (355 ml) glass bottle and 1 gallon HDPE Industrial Plastic Jugs, ¿ gallon HDPE Industrial Plastic Jugs. packaged in 12x12 fl oz, 6x12 fl oz, 4x1 gallon, 4x1/2 gallons. Refrigerate after opening. UPC Code 7 19660 00091 5, Kehe Case Code 1 99284 27227 9

Prima Foods International, Inc.
FDA FoodClass III

BarbaCuban 455 Everything Sauce (Original), Net Wt 12 oz (355 ml) glass bottle and 1 gallon HDPE Industrial Plastic Jugs, ¿ gallon HDPE Industrial Plastic Jugs. packaged in 12x12 fl oz, 6x12 fl oz, 4x1 gallon, 4x1/2 gallons. Refrigerate after opening. UPC Code 7 19660 00091 5, Kehe Case Code 1 99284 27227 9

Undeclared Quinine

Feb 11, 2026Prima Foods International, Inc.
Medical DeviceUSFDA Devices

Product Name: Disposable Triple Lumen Sphincterotome Model/Catalog Number: KD-431Q-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-431Q-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

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