Severity 3 of 5
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Severity 3 (High) recalls have a known hazard but no confirmed illness, injury, or property damage in the source text. The risk is theoretical-but-real: a pathogen pre-emptively pulled from shelves before anyone got sick, an allergen mislabeling on an uncommon allergen, a precautionary correction on a device that hasn't yet malfunctioned in the field. Most allergen recalls land here, as do most preventive food recalls based on routine sampling. You should still stop using the product, but you don't need to panic.
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.
GE Appliances is recalling about 11,000 JP3030 knob-control electric radiant cooktops because burners can remain on after being turned to the "off" position due to misaligned or fractured knob components, posing a burn hazard. No injuries have been reported.
Tiblue 8 oz and 12 oz stainless steel children's cups are being recalled because they contain lead in solder on the bottom exterior that exceeds federal limits, and the lids can crack and break during use, creating sharp edges and choking hazards.
DODO Baby House pack and play mattresses sold on Amazon violate federal crib mattress safety standards and pose a suffocation hazard to infants. Consumers should stop using the mattresses immediately and destroy them.
Berkshire Blanket & Home Co. is recalling about 29,840 heated throws and blankets because they may overheat, posing fire and thermal burn hazards. The firm has received nine reports of the products burning, melting, or overheating, with no injuries reported.
Klickpick Home is recalling about 3,600 stainless steel children's cup sets sold on Amazon from March through September 2023. The cups contain lead-bearing solder that exceeds federal limits, and the lids can crack and produce sharp edges and small parts.
Aizu Olympus is recalling 61 tracheal videoscopes (Model LF-V) due to an unvalidated air drying process that left water in channels after repair. Water in the endoscope channels may become contaminated and pose an infection risk.
Aizu Olympus is recalling 1577 ureteralscope units due to an unvalidated channel air drying process that left some units with residual water after repair, creating a contamination and infection risk.
Aizu Olympus is recalling 3,627 gastrointestinal videoscopes because the channel air drying process was not validated. A small percentage of devices returned after repair had wet channels, creating potential for contamination and risk of infection.
Aizu Olympus is recalling cystonephroscope endoscopes due to an unvalidated air drying process that allowed water to remain in instrument channels. Retained moisture poses a risk of contamination and infection.
Philips Ingenia 1.5T CX MRI systems may experience gradient coil failure that could produce smoke and/or fire. The FDA has classified this as a Class II recall affecting 48 units distributed nationwide and internationally.
Medline manual resuscitators are recalled due to a backwards leak in the integrated manometer that allows CO2 rebreathing. The defect affects multiple models used in respiratory care distributed nationwide.
Biomet is recalling Compress Device Short Anchor Plugs due to metal burrs that may prevent surgical instruments from passing through, potentially extending operative time.
ITF Pharma is recalling 1,792 bottles of Tiglutik (riluzole) oral suspension due to out-of-specification viscosity test results. The affected lots are 2231901 and 2307901, distributed to Tennessee.
Aizu Olympus is recalling uretero-reno fiberscopes because the channel air drying process was not validated. A small percentage of repaired devices had residual water in the channels, creating a risk of contamination and infection.
Instrumentation Laboratory is recalling GEM Premier 3000 PAK cartridges due to a defect that can produce falsely high blood oxygen readings. The inaccuracy may prevent detection of dangerously low oxygen levels and delay necessary treatment.
SunMed's Ventlab V-Care manual resuscitators are being recalled due to a backwards leak in the integrated manometer that allows CO2 rebreathing. Affected devices were distributed nationwide.
Aizu Olympus is recalling ultrasonic gastrovideoscopes due to an unvalidated channel drying process that left some scopes with water in the channels after repair. Water remaining in the device poses a risk of contamination and infection.
DBX Demineralized Bone Matrix Putty units labeled as 10cc contain only 1cc of product, which may result in prolonged surgery. Affected units distributed in PA, TX, and WA.
Aizu Olympus is recalling small intestinal videoscopes (Model SIF-Q180) because the channel air drying process was not properly validated. Water remaining in the channels could cause contamination and infection risk.
Biomet is recalling Compress Device Short Anchor Plugs due to metal burrs that may prevent proper surgical installation and extend operation time. Distribution includes US nationwide and eight other countries.
Convergent Dental is recalling 39 Solea laser surgical instruments due to potential unintended laser activation without foot pedal depression. No injuries have been reported.
SunMed Holdings recalls Ventlab STAT-Check manual resuscitators due to a backwards leak in the integrated manometer allowing CO2 rebreathing, which may impair ventilation. Multiple models (Adult, Infant, Pediatric) are affected and distributed nationwide.
Certain BD Extension Sets sold as free of DEHP (di(2-ethylhexyl) phthalate) actually contain this restricted phthalate. The products have been distributed worldwide.
Aizu Olympus has recalled 33 Mobile Airway Scope units due to an unvalidated air drying process. Some repaired units had wet channels, creating a potential risk of contamination and infection.
Philips is recalling SmartPath to dStream 1.5T MRI systems due to a potential gradient coil failure that could produce smoke or fire. The recall affects 119 units distributed nationwide and internationally.