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.
Prime-Time Specialty Vehicles is recalling 2014-2019 Ram ProMaster Paratransit vehicles because the transmission shifter cable may disconnect, causing unintended movement.
AB ULAX is recalling 1500 Flex Heat and Moisture Exchangers because they may disconnect from the respiratory circuit, potentially causing hypoxia or death.
Biomet is recalling OnPoint Scope Procedure Kits because they were not properly aligned with the gamma sterilization group, resulting in improper sterilization.
Siemens Medical Solutions USA is recalling ACUSON AcuNav Volume Intracardiac Echocardiography Catheters due to reports of left atrial perforations and Atrioventricular Node block.
Direct Rx is recalling 26 bottles of Ranitidine 300 mg tablets because the product was found to contain the NDMA impurity.
Roche Diagnostics is recalling BenchMark ULTRA Advanced Staining Systems due to a risk of fluid leaks causing electrical shorts, heat, and fire.
Direct Rx is recalling specific lots of Ranitidine 150 mg tablets because an NDMA impurity was detected. The affected products were distributed in Florida and Georgia.
Bombardier is recalling 2020 Can-Am Ryker motorcycles because improperly installed front wheels may separate, increasing crash risk.
Direct Rx is recalling 33 bottles of Losartan Potassium 100 mg tablets found to contain an impurity above acceptable levels.
PD-Rx Pharmaceuticals is recalling 20 bottles of Nature-Throid 1 GR tablets due to CGMP deviations and potential sub-potency. The product was distributed in Arizona and Oklahoma.
Daimler Vans USA is recalling 2020 Mercedes-Benz Sprinter vans because damaged brake hoses may leak fluid, increasing crash risk.
Roche Diagnostics is recalling the DISCOVERY ULTRA Advanced Staining System due to fluid leaks that can cause electrical shorts, heat, and smoke.
Hyundai is recalling 2019-2020 Kona Electric vehicles because the lithium-ion battery may short-circuit, increasing the risk of a fire.
Shyft Group is recalling 2020 Utilimaster Walk-In vans because the throttle pedal may get trapped by the floor tread plate, increasing crash risk.
Mercedes-Benz is recalling 2020 GLB 250 vehicles because the window air bag may not be mounted correctly, increasing injury risk in a crash.
Mercedes-Benz is recalling two 2020 GLE 350 vehicles because the driveshaft locking ring may not be installed correctly, potentially causing a loss of power transfer and vehicle stall.
Mercedes-Benz is recalling 2020 GLE and GLS models because a faulty electrical ground connection may cause power steering, wiper, or headlight malfunctions.
The FDA is recalling specific lots of Endo GIA Auto Suture Universal Articulating Loading Units because staples may not form properly, potentially preventing adequate hemostasis during surgery.
Riverpoint Medical is recalling 1,266 units of Velosorb Fast Braided Absorbable Sutures because they are non-sterile. The defect could compromise the sterile field and increase the risk of surgical site infections.
4e Brands North America is recalling Blumen Advanced Hand Sanitizer due to manufacturing in a facility associated with methanol contamination.
4e Brands North America is recalling Assured Instant Hand Sanitizer due to manufacturing in a facility associated with methanol contamination, representing poor CGMP practices.
4e Brands North America is recalling blumen Clear Advanced Hand Sanitizer because it was manufactured in a facility associated with methanol contamination, representing poor Current Good Manufacturing Practices.
Riverpoint Medical is recalling 1,256 units of Velosorb Fast Braided Absorbable Sutures because they are non-sterile, posing a risk of surgical site infection.
Philips North America, LLC is recalling 71 ProxiDiagnost N90 systems in the United States because an unexpected increase in peak tube potential may lead to increased patient radiation dose.
Eagle Family Foods is recalling 365 Organic Reduced Fat Popcorn because pieces of glass may be present in the product.