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.
Crestline Pharmaceuticals is recalling two lots of warfarin sodium tablets after a labeling error swapped 2.5 mg and 5 mg strengths.
Medline Industries is recalling 4,370 spinal anesthetic kits due to quality issues, including microbiology testing data integrity concerns and reported efficacy complaints.
Wawa recalls Diet Lemonade Pint bottles for undeclared milk allergen. Consumers with milk allergies should not consume this product.
Medline has recalled 270 bupivacaine injection kits due to microbiology testing data integrity concerns and reported efficacy complaints. The FDA classified this as a Class I recall.
MiniWarGaming Inc. and Primal Horizon are recalling approximately 22,624 disc magnets that violate mandatory safety standards. The high-powered magnets pose a deadly ingestion hazard to children.
Anzmtosn Luminous Fidget Spinner Balls are recalled because the included mini flashlight contains easily accessible button cell batteries that can cause serious internal injuries or death if swallowed by children.
Fontana Flavors is recalling VG7274D1 Natural Cream of Mushroom Type Flavor due to Salmonella contamination in milk powder used to manufacture the product. The product was distributed to Illinois, Tennessee, and Canada.
Squirrel Brand Travelers Mix nuts are recalled for potential Salmonella contamination. The FDA Class I recall affects approximately 3,858 cases distributed nationwide with best-by dates in April, May, and June 2027.
Ghirardelli Chocolate Company is recalling Perfectly Premium Frappe Mix products in three sizes due to potential Salmonella contamination. The recall affects products distributed across 26 U.S. states and several international countries.
Northfield Foods is recalling 187,000 lbs of sliced deli turkey after Listeria was found during routine testing.
Cook Incorporated is recalling Aurous Centimeter Sizing Catheters due to risk of marker band cracking or breakage during angiographic procedures. Potential complications include device fragmentation, vessel injury, and in worst-case scenarios, life-threatening harm or death.
French Broad Chocolate bonbons are recalled due to mislabeling of walnut content on the printed tasting guide. Consumers with nut allergies relying on the guide could accidentally consume a walnut-containing bonbon.
Cook Incorporated is recalling Centimeter Sizing Catheters because marker bands may crack or break, potentially causing device fragmentation, vessel injury, or life-threatening harm.
Raw Farm raw cheddar cheese with jalapeño peppers is recalled due to E. coli O157:H7 contamination linked to a multi-state outbreak.
Griffith Foods is recalling Costco Service Deli Department 63 Meatloaf Seasoning due to potential Salmonella contamination in the nonfat dry milk ingredient. The product was distributed to 15 states.
EEMB lithium coin battery packs sold online are not in child-resistant packaging as required by law. If swallowed by a child, these batteries can cause serious internal injuries or death.
OmniDose is recalling 23,000 lithium battery packs used in its X4 insulin pumps after reports of unexpected shutdown.
Omnipod 5 insulin pump pods from 49 lots have a manufacturing defect causing internal insulin leakage instead of delivery to patients. This risks dangerous blood sugar complications including diabetic emergencies.
B. Braun Hemodialysis Bloodlines may accumulate small air bubbles in the arterial line due to blood gases adhering to tubing under negative pressure. Approximately 1.17 million units have been recalled in this Class I FDA action.
Philips Respironics Trilogy EV300 ventilators may deliver an incorrect amount of air when used with non-pneumatic nebulizers, potentially affecting respiratory support in dependent patients.
CentrosFLO Hemodialysis Catheters are recalled due to a design defect that may prevent proper splitting of the sheath, risking hemorrhage, blood clots, and other serious complications.
Erbe USA Inc is recalling 3,603 flexible cryoprobes (REF: 20402-411) nationwide. The devices may rupture during use, posing patient safety risks.
Merit Medical Systems is recalling the BioFlo DuraMax Catheter due to a design defect that prevents proper splitting, which may result in hemorrhage, thrombosis, and other serious complications.
Vive Health is recalling about 122,000 portable bed rails due to entrapment hazards that can cause asphyxiation. Two deaths have been reported from entrapment incidents.
Mojo Max Fusion XXX capsules contain undeclared sildenafil and tadalafil, prescription drugs marketed without FDA approval. All lots (exp. 12/31/2027) distributed nationwide should not be used.