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.
Yummy brand Swirly Ices Tropical Tornado popsicles are recalled due to undeclared milk. The recall affects 275 boxes distributed to retail supermarkets in nine states.
Smiths Medical is recalling PORTEX Bivona neonatal and pediatric tracheostomy tubes worldwide due to a manufacturing defect in the securement flange that may tear and affect proper positioning.
Nuts.com is recalling 25-pound bags of paprika due to possible Salmonella contamination. Affected product was distributed to consignees in Virginia and Massachusetts.
Smiths Medical is recalling specific lots of PORTEX Bivona Tracheostomy Tubes because the securement flange may tear due to a manufacturing defect. These tubes are used for neonatal, pediatric, and adult patients worldwide.
Smiths Medical recalls PORTEX Bivona Neonatal Tracheostomy Tubes due to a manufacturing defect in the securement flange, which may tear. Affected patients should discontinue use and contact their healthcare provider.
Smiths Medical recalled specific lots of Bivona Tracheostomy Tubes after identifying a manufacturing defect that may cause the securement flange to tear, risking tube displacement.
Smiths Medical recalls specific lots of PORTEX Bivona neonatal and pediatric tracheostomy tubes due to manufacturing defects in the securement flange that may tear.
Yummy brand Swirly Ices popsicles are recalled due to undeclared milk allergen. The recall affects 282 boxes distributed across nine states.
Smiths Medical is recalling specific lots of PORTEX Bivona Tracheostomy Tubes because a manufacturing defect may cause the securement flange to tear.
Thor Motor Coach is recalling approximately 2,919 motorhomes with fuel hose clamps that may lack adequate clamping force, risking gasoline leaks and fires. Owners should contact dealers for free fuel hose and clamp replacement.
Smiths Medical is recalling specific lots of PORTEX Bivona neonatal and pediatric tracheostomy tubes because the securement flange may tear due to a manufacturing defect.
Smiths Medical recalled specific lots of PORTEX Bivona Tracheostomy Tubes due to a manufacturing defect that may cause the securement flange to tear. Affected products were distributed worldwide.
Prime Food brand steam buns may contain undeclared sesame, an allergen not listed on the product label. The FDA classified this as a Class I recall affecting 477 cases across multiple U.S. states and international locations.
Ford is recalling certain 2021-2022 E-350 and E-450 vehicles due to a defective power steering connection that may cause loss of power steering fluid and brake assist.
Glow in Dark Party Supplies Toy Sets sold on Amazon contain button cell batteries in Bunny Ears Headbands that can be easily accessed by children, posing a serious ingestion hazard. The sets violate federal battery-operated toy regulations.
Meijer Inc is recalling Meijer Dunking Cookies Chocolate Chip (10 oz) due to undeclared milk. The product poses a risk to consumers with milk allergies.
Aurohealth LLC is recalling Acetaminophen, Aspirin and Caffeine tablets because some bottles are missing the manufacturer's label containing drug facts information. Affected product was distributed in NJ, NY, and PA.
B. Braun Medical Inc. is recalling 63,444 containers of 0.9% Sodium Chloride Injection USP nationwide due to the presence of particulate matter. This intravenous medication may pose a serious health risk if administered to patients.
Covidien is recalling McGRATH MAC EMS Video Laryngoscopes due to a battery management system defect that may deplete below design specifications, creating risk of thermal events and explosion. About 10,449 units were distributed worldwide.
Inari Medical has updated instructions for the ClotTriever XL Catheter (30 mm) to prevent device entrapment and pulmonary embolism. Approximately 2,488 units distributed worldwide are affected.
Hikma Pharmaceuticals is recalling Acetaminophen Injection because bags of Dexmedetomidine HCl were found packaged inside Acetaminophen-labeled overWraps. The error could result in patients receiving the wrong intravenous medication.
Head Rush Technologies is recalling about 220 TRUBLUE Speed Auto Belay Devices because the backup brake can fail to activate, posing a fall hazard and risk of serious injury or death. Consumers should immediately stop using the devices and contact the manufacturer for a free inspection and repair.
ICU Medical is recalling Plum A+ and Plum A+3 infusion pump batteries due to a manufacturing defect that may cause premature capacity loss and reduced runtime. Approximately 14,744 units were distributed worldwide.
North Fish USA is recalling Cold Smoked Capelin packages due to potential Clostridium botulinum contamination in uneviscerated fish. The affected products were distributed in Georgia and New York.
Foppen Smoked Norwegian Salmon Slices (8.1oz vacuum foil packages) are recalled due to potential contamination with Listeria monocytogenes. The recall affects 747 cases distributed across 15 U.S. states.