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.
General Motors recalls 2017-2023 Chevrolet Bolt EV vehicles. After a crash with pretensioner deployment, pretensioner exhaust may ignite carpet near the B-pillar, creating a fire hazard.
Gyroor C3 e-bikes are recalled because the battery pack can ignite, creating fire and burn hazards. Gyroor has received reports of battery packs igniting and injuries requiring medical treatment, including burns and smoke inhalation.
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.
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.
Caire, Inc. is recalling five CAIRE Liberator 30 liquid oxygen system units due to weld defects on the inner bottle that could lead to device failure and loss of oxygen supply to dependent patients.
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.
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.
Sensititre MDRGN3F antibiotic test device may return false susceptible results for certain gram-negative bacteria, risking inappropriate antibiotic treatment. FDA Class I recall issued.
Boston Baking Mini Crumb Cake (3 oz, individually wrapped) is recalled for undeclared pecans. The product was distributed in six northeastern states and may pose a serious risk to consumers with tree nut allergies.
Remel Inc. recalled 8,073 units of Sensititre GN7F antibiotic susceptibility test plates after discovering they may report false results for certain bacteria, potentially leading to incorrect antibiotic treatment decisions.
Polestar is recalling 2020-2021 Polestar 1 vehicles because defective high-voltage battery cells may overheat and cause a fire. Dealers will replace the cells.
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.
Caire, Inc. is recalling 10 CAIRE Liberator 45 liquid oxygen system units due to inconsistencies in weld penetration on the inner bottle discovered during an FDA audit.
Williamsen-Godwin is recalling specific trailers equipped with Smart-Steer 2.0 axles because the steering arm may fracture. This defect can cause parts to separate, increasing the risk of a crash.
Thermo Scientific Sensititre CMC7AFLF Gram Negative diagnostic tests may produce false susceptible results for certain bacteria, potentially leading to ineffective antibiotic treatment decisions. The FDA has classified this as a Class I recall.
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.
GREEN DAY PRODUCE is recalling enoki mushrooms (UPC 16430-69080) due to Listeria monocytogenes contamination. Affected products were distributed to retailers and distributors in 12 states.
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.
Audi is recalling 96 2022 E-Tron GT vehicles because a retaining ring on the front suspension strut may come loose, potentially causing air loss and loss of vehicle control.
Ford is recalling certain 2022 and 2021 Bronco vehicles because the side impact sensors may not be properly secured. This could cause airbags to deploy unintentionally or fail to deploy in a crash, increasing injury risk.
Easymile is recalling 2018-2019 EZ10 autonomous passenger shuttles because a defective 48-volt battery may catch fire while charging.
A retaining ring on the 2021 Porsche Taycan's suspension strut may come loose, causing loss of vehicle control and increasing crash risk. Repairs will be provided free by Porsche dealers.
East Manufacturing is recalling 2018-2021 Frame Dump Trailers because the steering arm may fracture, potentially causing parts to fall and increasing crash risk.
Volvo Bus is recalling 2022 9700 buses because incorrectly installed GPS devices may cause accelerator sensor malfunction and loss of drive power.