Severity 5 of 5
Highest-severity recall. Risk of serious injury or death is documented or strongly suspected. Stop using the product now and follow the agency's instructions.
Severity 5 (Critical) covers recalls where deaths or serious injuries have been reported, or where the agency itself classified the action as the highest severity (FDA Class I, NHTSA 'death/serious injury reported'). These are the recalls you should treat as urgent — stop using the product immediately and follow the agency's guidance. Common Severity-5 categories are pathogen-contaminated ready-to-eat foods (Listeria, E. coli O157, Salmonella), drug products with confirmed adverse-event reports, and vehicle defects with documented fatal crashes.
The full rubric is on the methodology page. Severity is computed deterministically from the agency’s own classification plus the source text — no editorial vibes.
Windstone Medical Packaging is recalling 80 Aligned Medical Solutions ocular pack surgical kits because sterility of the included saline cannot be guaranteed.
Cardinal Health is recalling Dover brand Foley catheter kits due to components recalled by supplier Nurse Assist. Approximately 435,060 units were distributed to the US, Europe, Japan, and Latin America.
Cardinal Health is recalling all sizes of Monoject sterile syringes—including Luer-Lock and Enteral syringes with ENFit connections—due to manufacturing and rebranding changes. Products distributed across the U.S. and Canada.
Rugby brand Polyvinyl Alcohol 1.4% Lubricating Eye Drops are being recalled nationwide due to non-sterility. The recall affects all lots of the 0.5 FL OZ bottles distributed.
CVS Health Lubricant Gel Drops (Carboxymethylcellulose Sodium 1%) are being recalled nationwide due to non-sterility concerns. All lots of the product in single and twin pack bottles are affected.
FDA recalls DRY EYE RELIEF eye drops nationwide due to non-sterility. The ophthalmic product distributed in 23,208 bottles affects all lots. Consumers should discontinue use immediately.
CVS Health brand Lubricating Eye Drops are being recalled due to non-sterility. The FDA Class I recall affects 45,408 bottles distributed nationwide.
Rite Aid is recalling Multi-Action Relief Drops nationwide due to non-sterility concerns. The FDA classified this as a Class I recall affecting 9,216 bottles.
Cardinal Health is removing Monoject sterile syringes (Luer-Lock and Enteral with ENFit) from the market due to manufacturing and rebranding changes. Distribution affected US and Canada.
Walmart's EQUATE brand Hydration PF Lubricant Eye Drops are being recalled due to non-sterility. This FDA Class I recall affects 33,984 bottles distributed nationwide.
Fat Choy Kee Dried Longan produced by HY SUCCESS INC. is being recalled because it contains undeclared sulfites. Sulfites are a known allergen that poses health risks to sensitive individuals.
Denver Solutions recalled 8,976 IV bags of fentanyl citrate nationwide due to a malfunction in the semi-automated filling system that could deliver double the intended dose.
The FDA has recalled Zenzedi (Dextroamphetamine Sulfate) 30 mg tablets due to a labeling error. The recall affects 4,662 bottles distributed nationwide.
Denver Solutions is recalling 7,548 IV bags of vancomycin due to a manufacturing system malfunction that can deliver double doses. The product was distributed nationwide.
Denver Solutions is recalling 29,016 Phenylephrine HCl IV bags distributed nationwide. A filling system malfunction can result in some bags receiving double doses of this potent injectable drug.
GE HealthCare is recalling EvAir compressor kits for CARESCAPE and Engström ventilators due to elevated formaldehyde levels found in preliminary testing. The recall affects 1,294 units distributed worldwide.
DailySale Inc. is recalling its 216-piece 5mm Magnetic DIY Balls Magic Cube because the high-powered magnets violate federal toy safety regulations. When swallowed, the magnets can lodge in the digestive system and cause serious injury or death.
Huihuang Trading is recalling Fishing Games sold on Amazon.com from June through July 2023 because they contain magnets that exceed federal safety limits. Swallowed magnets can become lodged in the digestive system and cause serious injury or death.
Publix Custom Made Pizzas distributed in eight states are being recalled because the shredded lettuce ingredient may contain Listeria monocytogenes.
Tapee Tea packaged in paper packets is being recalled because samples contain undeclared pharmaceutical substances (dexamethasone and piroxicam). The contamination poses serious health risks from unintended medication exposure.
Publix Super Markets is recalling Custom Burrito Bowls due to potential Listeria monocytogenes contamination in the shredded lettuce ingredient. The bowls were distributed in Alabama, Florida, Georgia, Kentucky, North Carolina, South Carolina, Tennessee, and Virginia during December 5-14, 2023.
Herold Salads is recalling Rainbow Rotini salad packages in 1lb, 2lb, and 5lb sizes due to potential contamination with Listeria monocytogenes. The affected products were distributed in Ohio, Pennsylvania, and Michigan.
Herold Salads, Inc. is recalling potato salad products in 1lb, 2lb, 5lb, and 10lb tubs due to potential Listeria monocytogenes contamination. The recall affects products distributed in Ohio, Pennsylvania, and Michigan.
Herold Salads, Inc. is recalling Herold's Salad Shell Macaroni Salad in 1lb, 2lb, and 5lb containers due to potential Listeria monocytogenes contamination. The affected product was distributed in Ohio, Pennsylvania, and Michigan.
Herold Salads, Inc. is recalling Black Bean and Corn Salsa due to potential contamination with Listeria monocytogenes. Affected products were distributed in Ohio, Pennsylvania, and Michigan.