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.
Medtronic recalled the Heartware HVAD Outflow Graft worldwide due to higher rates of neurological events and mortality compared to other left ventricular assist devices, plus pump restart failures.
Medtronic is recalling 163 HeartWare HVAD Pump Implant Kits distributed worldwide due to higher rates of neurological adverse events, mortality, and pump malfunction compared to other cardiac assist devices.
Zen Magnets and Neoballs high-powered spherical magnets are being recalled because swallowing multiple magnets can cause intestinal perforation, blockage, and death. About 10 million magnets sold individually and in sets since January 2009 are affected.
Shogun-X capsules have been recalled because they contain undeclared tadalafil, sildenafil, and/or vardenafil—prescription drugs not listed on the label. These are unapproved drugs whose safety and efficacy have not been established.
Goose Creek Hand Sanitizer aloe Dragonfruit Splash (3.38 FL. OZ.) is being recalled because the product is contaminated with methanol, benzene, and acetaldehyde. Consumers should stop using the product immediately.
Nuri Trading LLC is recalling Thumbs Up 7 Black 25K capsules nationwide because they contain undeclared tadalafil, an FDA-approved drug. The product was marketed without required approval, making it an unapproved drug with unestablished safety and efficacy.
Scentsational Soaps & Candles Inc is recalling Goose Creek Hand Sanitizer aloe Melon Picnic spray (3.38 FL. OZ., Lot #20259) due to contamination with methanol, benzene, and acetaldehyde.
Nuri Trading LLC is recalling Shogun-X 7000 capsules nationwide because they contain undeclared tadalafil and sildenafil, FDA-approved prescription drugs not listed on the label, making the product an unapproved drug.
Scentsational Soaps & Candles Inc is recalling Goose Creek Hand Sanitizer Aloe Watermelon Lemonade due to contamination with methanol, benzene, and acetaldehyde. The 3.38 FL. OZ. bottles were distributed nationwide.
Scentsational Soaps & Candles Inc is recalling SS Tangerine & Guava Scented Sanitizer (3.38 FL. OZ.) due to contamination with methanol, benzene, and acetaldehyde. The product was distributed nationwide.
Krazy Night capsules (1-count blister cards and 10-count boxes) are being recalled nationwide because they contain undeclared tadalafil, sildenafil, and/or vardenafil without FDA approval. These unapproved drugs have not undergone safety and efficacy review.
NSNY Distributor Inc is recalling Ginseng Power 5000 capsules nationwide because they contain undeclared sildenafil and/or tadalafil, prescription medications not listed on the label or approved for sale in this product.
Premium OrgaZEN 7000 capsules distributed nationwide have been recalled because they were marketed without FDA approval and contain undeclared sildenafil and/or tadalafil, prescription drugs that pose serious health risks.
PremierZEN Platinum 8000 capsules, distributed nationwide, are being recalled because the product contains undeclared pharmaceutical ingredients (Sildenafil and Tadalafil) and was marketed without FDA approval.
Avid Medical is recalling 160 fistula care kits due to potential contamination from Aspergillus penicillioides fungal growth in a component applicator. The contamination could breach the kit's package integrity and affect other sterile components.
Pfizer has recalled 139,050 vials of injectable anesthetic medications due to a label mix-up: some vials labeled as Lidocaine contain Bupivacaine, and some labeled as Bupivacaine contain Lidocaine. Patients and healthcare providers should verify medication identity before use.
FDA recalls 22 serviced Alaris Model 8100 infusion pump units with bezel components that may crack or separate, risking free flow, over-infusion, under-infusion, or treatment interruption. Units distributed to Indiana and Texas between September 2020 and February 2021.