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.
Daimler Trucks North America is recalling 2021-2025 Thomas Built SAF-T-LINER C2 Jouley electric school buses because a high voltage inverter cable may not be secured properly, potentially causing a loss of drive power.
Vornado Air LLC is recalling approximately 1.75 million Steamfast Home & Away Travel Steam Irons because the power cord can become damaged near the bushing, posing fire, burn, and electrical shock hazards.
Savvy Rest is recalling about 84 quilted cotton mattress pads because they fail to meet the federal flammability standard for mattress pads and pose a fire hazard. No injuries have been reported.
CardioQuip is recalling 150 units of its Modular Cooler-Heater (Model MCH-1000m) due to potential heating-chamber malfunction that could cause component melting or burning. The device may overheat unexpectedly.
Elekta recalls Infinity radiation therapy systems for a detector arm defect that could cause uncontrolled extension if a microswitch is improperly configured. No injuries reported.
Wilson-Cook Medical is recalling QUANTUM TTC BILIARY BALLOON DILATORS due to nonconforming devices that may detach during use. Detachment could require endoscopic retrieval and carries a risk of bleeding.
Staar Surgical Company is recalling 9 EVO VISIAN intraocular lenses due to potential specification non-compliance. The affected devices were distributed to 40 US states.
BAPS Shayona is recalling 723 units of Plain Penda Ricotta fudge discs because some contain undeclared soy. The product was distributed to six states and poses a risk for those with soy allergies.
Heartware is providing updated instructions for the HVAD ventricular assist device to clarify Controller Fault alarm conditions and device useful life information for 892 implanted units worldwide.
BAPS Shayona Kaju Katri Kesar (cashew fudge with saffron) is being recalled because it contains undeclared Yellow #5 dye. The product was distributed to Alabama, Florida, Georgia, North Carolina, South Carolina, and Tennessee.
Wilson-Cook Medical recalled 731 QUANTUM TTC biliary balloon dilators due to design nonconformity that could cause balloon detachment. The device failure may require endoscopic retrieval and risks bleeding complications.
Staar Surgical recalls 51 EVO+VISIAN intraocular lenses due to potential specification non-compliance. Affected devices were distributed across multiple U.S. states.
STAQ Pharma is recalling ROPivacaine HCl 0.2% injection bags nationwide due to leaking bags caused by manufacturing quality control failures. No illnesses or injuries have been reported.
Randox is recalling RANDOX Total Bilirubin reagent because reports indicate elevated patient results when using plasma samples with this reagent.
Stryker ProCuity beds (model 3009) are missing electrical safety test values, presenting risks of electrical shock and tissue burns. FDA Class II recall.
Stryker's ProCuity bed series model 3009 lacks required electrical safety test documentation, creating a risk of tissue burns or electrical shock. The beds are distributed across North America, Europe, and other regions.
Integra LifeSciences is recalling 510 units of Cranial Access Kits due to a defect in outer packaging that can split spontaneously, compromising device sterility and increasing infection risk in neurosurgery.
IHB Operations is recalling Freedom Boom ceiling-mounted equipment dispensers due to weakened connection points on the suspension arm that could cause equipment failure. The defect affects 1,497 units distributed across multiple US states.
CooperSurgical H/S Catheter Sets may have defective bonding material causing component detachment or leakage. The sets are used in hysterosalpingography procedures to detect uterine abnormalities.
Integra LifeSciences is recalling 180 Cranial Access Kits due to a packaging defect that can cause splits, compromising the sterility of the surgical device.
HeartWare is issuing clarifications to instructions for the PUMP 1103 HVAD ventricular assist device regarding when Controller Fault alarms sound and component useful life. No illnesses or injuries have been reported.
Scoular Grain Co is recalling Milled Golden Flax MGDF in 50 lb bags due to plastic foreign object contamination. Affected lot numbers REG23261 and REG23268 were distributed to Texas and Canada.
Integra LifeSciences is recalling a cranial access kit due to a packaging defect that can cause the sterile outer packaging to split without additional force, potentially compromising device sterility.
Integra LifeSciences is recalling 485 Cranial Access Kits (Catalog INS7250) due to a packaging defect that can cause spontaneous splitting, compromising device sterility. The kits are used for surgical access to the brain.
Integra LifeSciences is recalling 1,639 units of its Cranial Access Kits because the outer packaging may split without additional external force, potentially compromising device sterility.