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.
Dewei DNA/RNA Preservation Kits (catalog DW-80005-1B) were distributed in the U.S. without FDA authorization or clearance. Approximately 1,348,000 units were distributed to California, Florida, Kentucky, and Michigan.
Remel Inc. is recalling a diagnostic test that may incorrectly report antibiotic susceptibility in certain Gram-negative bacteria. False results could lead to inappropriate antibiotic treatment.
Sensititre diagnostic plates may give false antibiotic susceptibility results for certain bacteria species, potentially affecting treatment decisions. The FDA issued a Class I recall for approximately 1,917 units distributed nationwide.
Caire, Inc. is recalling CAIRE Liberator 20 liquid oxygen system units due to weld penetration inconsistencies discovered during an FDA audit. The manufacturing defect affects 3 units.
Sensititre MDRGN3F antibiotic test device may return false susceptible results for certain gram-negative bacteria, risking inappropriate antibiotic treatment. FDA Class I recall issued.
Remel Inc is recalling 588 units of the Sensititre Gram Negative IVD AST diagnostic plate due to false susceptible test results for certain bacteria when tested with specific antibiotics. The defect could lead to incorrect treatment decisions.
The FDA recalled Sensititre GN6F Gram Negative antimicrobial susceptibility test plates (2,471 units) because they may report false results indicating bacteria are susceptible to certain antibiotics when they are actually resistant.
Caire Inc. is recalling 70 CAIRE Liberator 45 liquid oxygen systems due to inconsistencies in weld penetration on the inner bottle's longitudinal weld seam discovered during an audit.
Remel's Sensititre STP6F diagnostic plates may produce false susceptible results for Gram-negative bacteria when tested with certain antibiotics, potentially leading to inappropriate treatment decisions.
Ford is recalling 2022 Super Duty F-250 and F-350 vehicles due to an insufficient driver-side air bag cover that may break apart during a crash, projecting fragments toward occupants and increasing injury risk.
Daimler Trucks North America is recalling 2022-2023 Western Star 47X and 49X commercial trucks because the steering shaft's u-joint pinch bolt may detach, causing loss of steering control.
3M is recalling approximately 516,500 Scotch TL1302 Thermal Laminators because a safety feature can malfunction when the device overheats, posing a fire hazard. The company has received nine reports of the laminators catching fire, with three reports of minor property damage but no injuries.
Ortal USA is recalling about 400 Traditional 90 and Traditional 110 gas fireplaces due to improper installation that can cause fire hazards. The firm has received four reports of installation errors resulting in fires with property damage.
Choi Heong Yuen Bakery Almond Cakes may contain undeclared milk. Consumers with milk allergies who purchased this product should stop consuming it and contact the manufacturer.
Ford is recalling certain 2021 F-350 SD and F-450 SD vehicles with fifth wheel left-hand mounting brackets that may be cracked. A cracked bracket could result in the fifth wheel detaching during towing, increasing crash risk.
DTNA is recalling 2019-2021 Western Star 4700 and 5700 vehicles with undersized ground harness wiring that may cause connector melting and engine stall, increasing crash risk. Owners should contact DTNA for free replacement.
Ford is recalling certain 2020-2021 F-53 and F-59 motorhome and commercial chassis vehicles due to inadequate rear axle lubricant. The defect may cause rear wheel bearing damage, rear axle failure, and loss of motive power and brake function.
eWheels LLC is recalling about 500 Gotway and Begode electric unicycles because their lithium-ion batteries can ignite, creating a fire hazard. Fourteen fire incidents have been reported, including property damage and one injury.
Whele LLC is recalling the Mighty Bliss Electric Heating Pad (model MB-001) due to burn and electrical shock hazards. The firm has received complaints of burns, shocks, and skin rashes from users.
3M Healthcare is recalling Steri-Drape surgical drapes due to an adhesive component that causes skin injuries and may render the product unusable. Affected: 104,000 units worldwide.
Umami Everyday Savory Spice is recalled nationwide due to undeclared soy. The product affects consumers with soy allergies and has been distributed in the US, Canada, UK, and France.
3M is recalling 43,200 units of Steri-Drape surgical drapes due to a difficult-to-remove adhesive liner that may damage the product and reported increases in skin injuries.
3M is recalling approximately 14,360 units of Steri-Drape surgical drapes due to adhesive-related skin injuries. The product's adhesive liner is difficult to remove and may render the drape unusable.
3M is recalling 103,000 units of Steri-Drape surgical drapes worldwide due to difficulties removing the adhesive liner and an increase in reported skin injuries from the adhesive.
Wild caught Alaskan Sockeye smoked salmon may be contaminated with Listeria monocytogenes. Seven Seas International USA LLC is recalling 540 cases distributed to 164 retail stores.