United States Recalls

Consumer recalls from the FDA, CPSC, NHTSA, and USDA FSIS.

Showing 24 of 16,533 results
Medical Device
FDA DevicesClass II

Straumann n!ce Zr, HT, Full-arch Restoration. Article 010.0158. Endosseous De...

Includes an incorrect screw seat interface.

May 6, 2026Straumann USA LLC
Medical Device
FDA DevicesClass II

Medline medical procedure kits, containing Medline Neuro Sponges, labeled as fol...

During an internal review, Medline identified higher-than-expected endotoxin levels on a representative Medline neuro sponge product, indicating that in-market product may be out-of-specification for endotoxin.

May 6, 2026Medline Industries, LP
Medical Device
FDA DevicesClass II

Medline medical procedure kits, containing Medline Neuro Sponges (961 in total),...

During an internal review, Medline identified higher-than-expected endotoxin levels on a representative Medline neuro sponge product, indicating that in-market product may be out-of-specification for endotoxin.

May 6, 2026Medline Industries, LP
Medical Device
FDA DevicesClass II

Medline medical procedure kits, containing Medline Neuro Sponges, labeled as fol...

During an internal review, Medline identified higher-than-expected endotoxin levels on a representative Medline neuro sponge product, indicating that in-market product may be out-of-specification for endotoxin.

May 6, 2026Medline Industries, LP
Medical Device
FDA DevicesClass II

Medline medical procedure kits, containing Medline Neuro Sponges, labeled as fol...

During an internal review, Medline identified higher-than-expected endotoxin levels on a representative Medline neuro sponge product, indicating that in-market product may be out-of-specification for endotoxin.

May 6, 2026Medline Industries, LP
Food & Beverage
FDA FoodClass I

Black label with blue lettering. FOOD Korean Food, ENOKI MUSHROOM, 150g clear pl...

product tested positive for Listeria Monocytogenes.

May 6, 2026HEMU TRADING INC
Medical Device
FDA DevicesClass II

Centurion medical convenience kits, containing Webcol Large Alcohol Prep Pads, l...

Medline Industries, LP is issuing a recall for specific item(s) and lot(s) of Medline Kits containing Cardinal Health Webcol Large Alcohol Prep Pads. Cardinal Health has deemed Webcol Large Alcohol Prep Pads to be non-sterile following the discovery of a contaminant (Paenibacillus phoenicis) during a routine sterilization dose audit.

May 6, 2026Medline Industries, LP
Food & Beverage
FDA FoodClass II

My Mochi Strawberry flavored Non-Dairy Frozen Dessert; 7.5 oz; 6 pieces per cont...

Foreign object found inside retail container.

May 6, 2026The Mochi Ice Cream Company, LLC
Medical Device
FDA DevicesClass II

Medline and Centurion medical convenience kits, containing Webcol Large Alcohol ...

Medline Industries, LP is issuing a recall for specific item(s) and lot(s) of Medline Kits containing Cardinal Health Webcol Large Alcohol Prep Pads. Cardinal Health has deemed Webcol Large Alcohol Prep Pads to be non-sterile following the discovery of a contaminant (Paenibacillus phoenicis) during a routine sterilization dose audit.

May 6, 2026Medline Industries, LP
Medical Device
FDA DevicesClass II

Depuy Synthes, ATTUNE REVISION HINGE FEMORAL RT SZ 5 CEM. Part Number: 150450205...

The external sterile packaging was found adhered to the internal sterile packaging, potentially compromising sterility.

May 6, 2026DEPUY (IRELAND)
Food & Beverage
FDA FoodClass II

52USA brand POPPING BOBA; PASSION FRUIT FLAVOR; Net wt: 7 lb (3.2kg); Ingredient...

Products contain unapproved colors, specifically tartrazine (FD&C Yellow 5), sunset yellow (FD&C Yellow 6), and allura red (FD&C Red 40).

May 6, 2026Guangdong Zonegoing Food Co., LTD
Medical Device
FDA DevicesClass II

Medline medical procedure kits, containing Medline Neuro Sponges, labeled as fol...

During an internal review, Medline identified higher-than-expected endotoxin levels on a representative Medline neuro sponge product, indicating that in-market product may be out-of-specification for endotoxin.

May 6, 2026Medline Industries, LP
Medical Device
FDA DevicesClass II

Philips Ingenia Ambition X with MR Elastography (MRE). 1. Model Number (REF)...

The potential for stiffness value errors when a specific range of image reconstruction parameters is used in combination with Resoundant's algorithm, leading to the reconstruction voxel size settings in the default MRE scan protocol displaying too small.

May 6, 2026Philips North America
Pharmaceutical
FDA DrugsClass II

Optase Dry Eye Intense Drops (Glycerin 0.2%), packaged in 0.33 fl oz, Sterile, M...

Lack of Assurance of Sterility

May 6, 2026SCOPE HEALTH
Medical Device
FDA DevicesClass II

Medline medical procedure kits, containing Medline Neuro Sponges, labeled as fol...

During an internal review, Medline identified higher-than-expected endotoxin levels on a representative Medline neuro sponge product, indicating that in-market product may be out-of-specification for endotoxin.

May 6, 2026Medline Industries, LP
Medical Device
FDA DevicesClass II

Philips Bridge Prep Kit REF: K12-09098C Sterile EO, Rx ONLY

catheter may experience resistance when being advanced over the guidewire

May 6, 2026Merit Medical Systems, Inc.
Medical Device
FDA DevicesClass II

Philips SmartPath to dStream for XR and 3.0T with MR Elastography (MRE). 1. ...

The potential for stiffness value errors when a specific range of image reconstruction parameters is used in combination with Resoundant's algorithm, leading to the reconstruction voxel size settings in the default MRE scan protocol displaying too small.

May 6, 2026Philips North America
Food & Beverage
FDA FoodClass II

52USA brand POPPING BOBA; MANGO FLAVOR; Net wt: 7 lb (3.2kg); Ingredients Drinki...

Products contain unapproved colors, specifically tartrazine (FD&C Yellow 5), sunset yellow (FD&C Yellow 6), and allura red (FD&C Red 40).

May 6, 2026Guangdong Zonegoing Food Co., LTD
Medical Device
FDA DevicesClass II

Philips Achieva 1.5T with MR Elastography (MRE). 1. Model Number (REF): 7811...

The potential for stiffness value errors when a specific range of image reconstruction parameters is used in combination with Resoundant's algorithm, leading to the reconstruction voxel size settings in the default MRE scan protocol displaying too small.

May 6, 2026Philips North America
Medical Device
FDA DevicesClass II

Medline and Centurion medical procedure kits, containing Medline Neuro Sponges (...

During an internal review, Medline identified higher-than-expected endotoxin levels on a representative Medline neuro sponge product, indicating that in-market product may be out-of-specification for endotoxin.

May 6, 2026Medline Industries, LP
Medical Device
FDA DevicesClass II

Medline medical procedure kits, containing Medline Neuro Sponges, labeled as fol...

During an internal review, Medline identified higher-than-expected endotoxin levels on a representative Medline neuro sponge product, indicating that in-market product may be out-of-specification for endotoxin.

May 6, 2026Medline Industries, LP
Food & Beverage
FDA FoodClass II

KLG, Kesar Mukhwas, perishable, 24 months, flexible plastic, 200 gm, 81881202220...

Undeclared food colorings (Yellow 6, Blue 1, and Yellow 5) and unapproved Acid Red 14.

May 6, 2026Ganesha Enterprises LLC
Medical Device
FDA DevicesClass II

Mesh Style Tip Protectors CSW-03-2.0 Open-end style CSW-04-4.0 Closed-end styl...

Product does not have FDA clearance.

May 6, 2026Healthmark Industries Co., Inc.
Medical Device
FDA DevicesClass II

Philips SmartPath to Ingenia Elition X with MR Elastography (MRE). 1. Model ...

The potential for stiffness value errors when a specific range of image reconstruction parameters is used in combination with Resoundant's algorithm, leading to the reconstruction voxel size settings in the default MRE scan protocol displaying too small.

May 6, 2026Philips North America
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