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.
Sagent Pharmaceuticals is recalling Docetaxel Injection due to particulate matter from the vial stopper contaminating the drug. The recall affects 2,806 vials distributed nationwide.
About 2,600 magnetic chess games with 20 magnet pieces sold on Temu.com from December 2023 through February 2024 are recalled because the magnets violate federal toy magnet regulations and pose a serious ingestion hazard.
Danisco USA Inc. is recalling Grindsted Hi-Dress CDS 1880 Stabilizer and Emulsifier System due to potential Salmonella contamination. The product was distributed to facilities across multiple US states, Canada, and Mexico.
Danisco USA Inc. has issued a recall of Grindsted ASC 2354 Stabilizer and Emulsifier System for potential Salmonella contamination. The product is distributed to multiple US states, Canada, and Mexico.
Danisco USA Inc. is recalling GS 1134 Kreme WIP, a food ingredient product, due to potential Salmonella contamination affecting multiple U.S. states, Canada, and Mexico.
Danisco USA Inc. is recalling Germantown Gard (A) Preservative due to potential Salmonella contamination. The recall affects 21,000 kg distributed across the US, Canada, and Mexico.
Danisco USA Inc. is recalling Grindsted Yogurt 7133 Stabilizer System due to potential Salmonella contamination. The affected ingredient was distributed to multiple U.S. states, Canada, and Mexico.
Danisco USA Inc. is recalling Grindsted Creamer 2395 Stabilizer and Emulsifier System due to potential Salmonella contamination. The product was distributed across the US, Canada, and Mexico.
Megadyne Medical Products is recalling its MEGA SOFT Pediatric Patient Return Electrode due to reports of patient burns during electrosurgical use. Approximately 1,270 units distributed worldwide are affected.
Good Earth Lighting is recalling more than 1.2 million rechargeable integrated lights whose lithium-ion batteries can overheat and ignite the plastic housing, posing fire and burn hazards. One death has been reported.
Medline is recalling about 1.5 million Bed Assist Bar adult bed rails because users can become entrapped between the rail and mattress, posing a risk of asphyxiation. Two deaths have been reported.
Hikma Injectables USA Inc is recalling phenylephrine injection syringes that were mislabeled as containing ephedrine. The mix-up creates a serious risk of administering the wrong medication to patients.
Boston Scientific is recalling Expo 5F Selective Angiographic Catheters due to complaints of guidewire advancement problems and polyurethane delamination in the catheter lining. Affected catheters are distributed worldwide.
Boston Scientific is recalling 9,271 Expo 5F Selective Angiographic Catheters due to polyurethane delamination that can prevent guidewire advancement. The defect was found in certain batches with worldwide distribution.
Boston Scientific recalls Expo 5F Selective Angiographic Catheters due to polyurethane layer delamination and material detachment that may prevent guidewire advancement during cardiac procedures. Affected batches 60443927 and 60495422 have been distributed worldwide.
Boston Scientific recalled 2,314 Expo 5F cardiac catheters due to polyurethane delamination in the inner lining. The defect can prevent guidewire advancement during angiographic procedures.
Boston Scientific is recalling Expo 5F Selective Angiographic Catheters due to polyurethane delamination of the inner lining. The defect prevents guidewire advancement and affects 330 units worldwide.
Belgian Yummies recalls Chocolate Ice Cream Cookie Sandwiches distributed in Florida due to undeclared allergens: milk, eggs, wheat, peanuts, and tree nuts. Consumers with allergies should not consume this product.
Thoratec HeartMate 3 left ventricular assist system implant kits may develop a leak at the seal interface between the inflow cannula and titanium apical cuff, potentially compromising device function.
Pyramids Wholesale Inc. is recalling Silverback XXX Power male enhancement nationwide due to undeclared sildenafil and/or tadalafil. These prescription drugs were not approved by the FDA before marketing.
Alcoholada Gel pain reliever is being recalled because the ethanol ingredient contains methanol contamination. The FDA classified this as a Class I recall affecting 9,625 bottles distributed nationwide.
Route 92 Medical 070 Access System catheters are recalled for potential distal tip separation during neurovasculature procedures. The defect affects 117 units distributed across 30 US states and New Zealand.
HandNatural recalls H&Natural Brazil Seed supplement due to presence of yellow oleander and its components. The product was distributed via internet sales.
H&Natural is recalling tejocote root supplement due to the presence of yellow oleander and its components. The product was distributed exclusively through internet sales.
Robeson Enterprises is recalling Mo' Money Pie due to undeclared soy allergen on the label. The product was distributed to Georgia, North Carolina, and South Carolina.