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.
Bell Sports is recalling about 2,360 Bell Slope Adult Helmets because the strap anchor can dislodge during impact, violating safety standards and risking head injury in a crash.
UBBCARE play yard mattresses violate federal safety standards for crib mattresses and pose a suffocation hazard to infants. The mattresses are missing required warnings and labels and fail thickness tests. No injuries have been reported.
Homedics is recalling about 46,000 Therapist Select Percussion Personal Massagers (model HHP-715) because they can overheat while charging, creating fire and burn risks. The company has received 17 overheating reports, including one burn injury.
Atrium Oasis surgical drain recalled due to sterilization nonconformance that shortened the product's shelf life. Affected units were distributed nationwide and may not maintain sterility if used after November 17, 2025.
Cardinal Healthcare is recalling Nyamyc topical antifungal medication (Batch 400454) nationwide due to exposure to temperatures outside labeled storage conditions.
Cardinal Healthcare is recalling Estradiol 0.5mg tablets (Batch 100023687) nationwide due to exposure to temperatures outside labeled storage specifications. Temperature exposure may affect medication stability.
Cardinal Healthcare recalls Warfarin Sodium tablets distributed nationwide due to products being exposed to improper storage temperatures.
The Medtronic SynchroMed II pump may fail to resume drug delivery after MRI if electromagnetic interference triggers telemetry mode while the pump is alarming. This could interrupt essential medication delivery in patients.
Donepezil Hydrochloride 10mg tablets are recalled due to exposure to temperatures outside labeled storage conditions. The FDA classified this Class II recall due to potential effects on drug stability.
Abbott Laboratories is recalling 8,424 Alinity ci-series System Control Module units due to software performance issues that could produce erroneous test results. Affected systems are used in clinical laboratories throughout the United States and 90+ countries.
Cardinal Healthcare recalls batch 62002532 of Wixela Inhub inhalation powder nationwide due to CGMP deviations. Products were exposed to temperatures outside labeled storage conditions, potentially affecting product stability.
Cardinal Healthcare is recalling an ipratropium bromide and albuterol sulfate inhalation solution nationwide after the product was exposed to temperatures outside labeled storage conditions. The deviation may affect drug potency.
Acumed LLC recalls 513 RibLoc U Plus 90 surgical guides due to potential breakage during use. The device is used in orthopedic rib fixation procedures.
Cardinal Healthcare is recalling Lisinopril and Hydrochlorothiazide Tablets (10mg/12.5mg) manufactured by Lupin Limited because products were exposed to temperatures outside the labeled storage conditions. Affected batches are Q101699 and Q101981 distributed nationwide.
AnazaoHealth Corporation is recalling 3,363 vials of Thiamine HCl/Pyridoxine HCl injection solution nationwide due to the presence of particulate matter. Affected lots are identified by lot numbers and expiration dates listed by the FDA.
Arjo medical beds with IndiGo Drive Assistance modules may have wheels that move unintentionally. This recall affects 83 units in seven U.S. states.
Sandoz Inc is recalling Enoxaparin Sodium Injection (batch SAH06821A) nationwide due to CGMP deviations: products were exposed to temperatures outside labeled storage conditions, potentially affecting drug stability.
Arjo medical beds with IndiGo Drive Assistance modules may experience unintended wheel movement. The recall affects 846 units distributed across seven US states.
Cardinal Healthcare is recalling Donepezil Hydrochloride 5 mg tablets (Batch 17605) distributed nationwide because they were exposed to temperatures outside labeled storage conditions, which could affect drug stability.
AnazaoHealth is recalling B-Complex injection vials due to particulate matter contamination. Affected patients should discontinue use and consult their healthcare provider.
Cardinal Healthcare is recalling Albuterol Sulfate inhalers (Batch K100715) due to CGMP deviations where products were exposed to temperatures outside labeled storage conditions. Approximately 11 cartons were distributed nationwide. Contact your pharmacist or doctor for a replacement.
Cardinal Healthcare recalls Warfarin Sodium Tablets (5 mg) nationwide due to CGMP deviations: products were exposed to temperatures outside labeled storage conditions, potentially affecting drug stability.
Cardinal Healthcare is recalling Rivastigmine Transdermal System patches (4.6 mg/24 hours) distributed nationwide because they were exposed to temperatures outside labeled storage conditions during manufacturing.
Cardinal Healthcare is recalling Amoxicillin 875mg tablets due to CGMP deviations where products were exposed to temperatures outside their labeled storage conditions, affecting nationwide distribution.
DeRoyal Industries is recalling a cardiac catheterization kit that contains Edwards Life Sciences pressure transducers that were subject to a separate recall by their manufacturer.