Severity 4 of 5
The hazard poses a serious risk of illness, injury, or structural failure. 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.
NewDeal SA is recalling ADVANSYS TTC medical devices because they may cause superficial or deep infections requiring antibiotic treatment or device removal.
Avella of Deer Valley is recalling 10,500 ephedrine sulfate syringes nationwide due to potential bag leakage and lack of sterility assurance.
Avella of Deer Valley, Inc. is recalling 700 bags of Epinephrine (USP) 4 mg due to potential leakage that compromises sterility.
Avella of Deer Valley is recalling 1,352 bags of Vancomycin 1.25gm in D5W 250 mL due to potential leakage that compromises sterility.
Avella of Deer Valley is recalling 100 fentanyl and ropivacaine cassettes due to potential bag leakage and lack of sterility assurance.
Medtronic is recalling Tri-Staple 2.0 Intelligent Reloads because a missing sled component may prevent staple formation, leading to bleeding or leakage.
La Vita Compounding Pharmacy is recalling Methyl Folate CA+ 1mg/ml Injection vials because production methods raised questions about the sterility of the drug product.
Medtronic is recalling specific Endo GIA 60 mm reloads because a missing sled component may prevent staple formation, potentially causing bleeding or leakage.
La Vita Compounding Pharmacy is recalling 191 vials of Glutathione 200mg/mL Injection because production methods raised questions about the sterility of the drug product.
Medtronic is recalling Tri-Staple 2.0 Curved Tip Intelligent Reloads because a missing sled component may prevent staple formation, potentially causing bleeding or leakage.
Avella of Deer Valley is recalling 120 fentanyl syringes due to potential bag leakage and lack of assurance of sterility.
Avella of Deer Valley, Inc. is recalling 740 single-dose Morphine 150 mg syringes due to a lack of assurance of sterility caused by potential bag leakage.
SynTec is recalling S3B 45-inch Restraint School Bus Seats because the mounting foot may pull through the bolted joint at the bus floor, increasing injury risk in a crash.
Meritor is recalling specific wheel studs installed in steer axle hubs because improper heat treatment may cause them to fail, potentially leading to wheel detachment.
Jost International is recalling certain Outboard Sliders because a narrow bracket may allow the trailer to separate from the tractor, increasing crash risk.
Braun Corporation is recalling 2012-2018 BraunAbility Dodge and Chrysler wheelchair vans because brake lines may be disconnected, reducing electronic stability control performance.
Daimler Trucks is recalling 2018-2019 Freightliner Business Class M2 trucks because an incorrectly installed steering shaft may disconnect the steering wheel from the front wheels.
Ducati is recalling 2018 Panigale and Hypermotard motorcycles because rear brake pad friction material may detach, increasing stopping distance and crash risk.
Polaris is recalling 2011-2016 GEM electric vehicles because a cracked lower frame tube can cause the upper cab frame to fail, increasing injury risk.
Polaris is recalling 2016-2017 GEM E2, E4, E6, and ELXD vehicles because a faulty drive mode switch may cause the vehicle to move in the opposite direction intended.
Brew Dr. Kombucha is recalling Clear Mind kombucha bottles because glass fragments were found inside. Consumers should stop using the affected products.
Daimler Trucks North America is recalling 2019 Freightliner Cascadia trucks equipped with specific Continental tires because visible cords may cause sudden air loss and loss of vehicle control.
Stryker GmbH is recalling specific femoral nails because non-conforming cannulation may reduce strength and cause premature breakage.
Brembo is recalling certain Federal Mogul rear brake pads because the material may detach from the back plate, potentially affecting braking performance.
Daimler Trucks North America is recalling 2019 Freightliner Cascadia trucks equipped with specific Continental tires that may lose air suddenly, increasing crash risk.