Severity 4 of 5
Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.
Severity 4 (Severe) recalls have a real, documented risk of significant injury, hospitalization, or property damage even if no deaths have been reported. The agency classification is FDA Class II with hospitalization reports, USDA Class I, or a structural vehicle defect. These need attention quickly — not five-alarm urgency but not something to put off. Examples include allergen mislabeling on common allergens for products eaten by children, drug potency out of specification by a margin that could cause measurable harm, and vehicle defects affecting braking or steering.
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.
Harbor Freight Tools is recalling about 350,000 One Stop Gardens tank top propane heaters because wind can redirect the flame to melt the safety shutoff, preventing the heater from turning off if tipped. Three minor burn injuries have been reported.
Sanit Technologies is recalling Durisan Antimicrobial Solutions Hand Sanitizing Wipes because certain lots were found to contain Burkholderia contaminans and/or yeast and mold through internal testing.
Philips Respironics BiPAP ventilators' polyurethane foam may degrade into particles that could be inhaled or ingested, or off-gas certain chemicals. About 8,047 devices worldwide are affected.
Sanit Technologies is recalling Durisan Antimicrobial Solutions hand sanitizer due to internal testing that found contamination with Burkholderia contaminans and/or yeast and mold in certain lots.
Philips Respironics ventilators are recalled because foam components may degrade and release particles and chemicals that patients could inhale.
Philips Respironics is recalling approximately 255,810 continuous ventilators because polyurethane foam may degrade into particles that could be inhaled or ingested, or release chemicals.
Dual chamber INGENIO DR EL pacemakers with Extended Life batteries may develop high internal impedance, causing devices to enter Safety Mode later in life. Affected patients should contact their healthcare provider about replacement.
Boston Scientific is recalling VITALIO DR EL pacemakers with Extended Life batteries due to a latent battery condition that may cause unexpected device resets and Safety Mode activation later in device life.
Cooked frozen snow crab sections from Crustaces Baie-Trinite Inc. are being recalled due to potential contamination with Salmonella and Listeria monocytogenes. The affected product was distributed to restaurant distributors in Massachusetts and Missouri.
Boston Scientific recalls dual chamber INGENIO family pacemakers and CRT-Ps with Extended Life batteries that may develop high internal impedance, causing Safety Mode and system resets, requiring device replacement.
Boston Scientific is recalling ADVANTIO DR EL dual chamber pacemakers and CRT-Ps due to a latent battery condition that may cause system resets and trigger Safety Mode, requiring device replacement.
Poseidon Platinum 3500 capsules are being recalled because they contain undeclared sildenafil and tadalafil, which are prescription drugs that were not approved for this product. The safety and efficacy of these undeclared ingredients have not been established.
Philips Respironics recalled 72,665 BiPAP A-Series ventilators worldwide. The foam in these devices may degrade into particles that could be inhaled or ingested, and may release chemicals.
Boston Scientific is recalling INGENIO CRT-P pacemakers that may develop high internal battery impedance, causing unexpected device resets and Safety Mode activation. Affected devices require replacement.
Philips Respironics E30 ventilators may have polyurethane foam that degrades into particles. These particles can enter the air pathway and be inhaled or ingested by patients, or the foam may off-gas chemicals.
Teva Pharmaceuticals is recalling Topotecan Injection 4 mg/4mL single-dose vials due to the presence of particulate matter, including glass, silicone, and cotton fiber, found inside affected vials.
Alvogen, Inc. is recalling Buprenorphine and Naloxone Sublingual Film 2mg/0.5mg due to out-of-specification assay results showing low levels of both naloxone and buprenorphine.
LoHi Tech is recalling about 24,900 SOWTECH Espresso Machines (Model CM6811) because the glass carafe can break during use, posing a burn hazard. The firm has received 48 reports of breaking carafes, resulting in five burn injuries.
Lakeview Farms LLC is recalling Smilin' Bob's Key West Style Smoked Fish Dip in 8 oz and 15.5 oz containers due to potential Listeria monocytogenes contamination. The product was distributed to five distributors in Florida.
ProtectoRx hand sanitizer (ethyl alcohol 70%) is being recalled nationwide because some lots were found to contain methanol and all lots were manufactured under the same conditions as the contaminated product.
The LeadCare II Blood Lead Test Kit may generate artificially low control test results, causing blood lead levels to be underestimated in patient samples. Kits were distributed worldwide.
DiBAR LABS Hand Sanitizer (ethyl alcohol 70%, 8 FL OZ) is being recalled because FDA testing found three lots contain methanol contamination and have ethanol content below the label claim.
Interstate Food Products is recalling Little Hatch's Spicy Queso due to Listeria monocytogenes contamination and undeclared soy lecithin. The product was distributed across multiple states.
Dibar Labs is recalling Advance Hand Sanitizer (70% ethyl alcohol, 16 FL OZ) distributed nationwide because it was manufactured under the same conditions as lots found to contain methanol.
Interstate Food Products is recalling Little Hatch's Roasted Chili Salsa (Hot, 13.5 oz) because product samples tested positive for Listeria monocytogenes, a potentially harmful bacteria.