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.
Thor Photomedicine's NovoTHOR Gen 2.5 therapy beds are being recalled due to failure of ball stud components in the gas strut, which can detach from the canopy. This affects 26 units distributed across the US and internationally.
BAPS SHAYONA Surti Ghari sweet dumplings are recalled due to undeclared soy and Yellow #6 dye. The product was distributed in Alabama, Florida, Georgia, North Carolina, South Carolina, and Tennessee.
HeartWare is updating documentation for 380 HVAD cardiac assist devices to clarify Controller Fault alarm conditions and device lifetime instructions.
BAPS Shayona is recalling Mohanthal (chickpea flour fudge) distributed in six states due to undeclared soy and dyes (Yellow #5, #6). The product poses risk to consumers with soy allergies or sensitivities.
Wilson-Cook Medical is recalling 941 biliary balloon dilators that may detach during use. Detachment could require doctors to retrieve the device with an endoscope, which may cause bleeding.
Stryker is recalling ProCurity model 3009 patient beds because they lack required electrical safety testing, creating a risk of electrical shock or tissue burn. Affected units were distributed nationwide and internationally.
Certain Elekta Versa HD radiation therapy systems may experience uncontrolled detector arm extension due to microswitch setup issues. This recall affects 451 systems worldwide.
Padagis US LLC is recalling Trospium Chloride Extended-Release Capsules (60 mg) due to manufacturing defects where some capsules contain missing, broken, or extra tablets. The recall affects 7,032 bottles distributed nationwide.
Elekta is recalling 264 units of its Synergy Platform radiation therapy systems due to a microswitch defect that could cause uncontrolled extension of detector arms. The systems were distributed worldwide.
Stryker ProCuity patient beds lack required electrical safety test values, posing risk of tissue burn or electrical shock to patients and healthcare workers.
Thor Photomedicine is recalling 19 NovoTHOR Gen 2.0 red light therapy beds due to ball stud component failures that can cause canopy detachment or difficulty in lifting. The beds were distributed worldwide.
Integra LifeSciences is recalling the Integra Cranial Access Kit due to a defect in the outer packaging that can split and compromise device sterility. A total of 173 units are affected.
Honda recalls 2020-2022 CR-V Hybrid vehicles whose 12-volt battery cable is missing a fuse on the power circuit, which can cause short circuits or overheating during crashes and increase the risk of fire or injury.
Stryker is recalling ProCurity patient beds (model 3009) due to missing electrical safety test documentation. Affected beds pose a risk of electrical shock or tissue burns. Facilities should verify their bed serial numbers and contact Stryker.
KinderFarms is recalling approximately 376,370 bottles of Infants' Pain and Fever acetaminophen oral suspension nationwide due to failures in impurity and degradation specifications.
Heartware is updating instructions for the HVAD ventricular assist device to clarify controller fault alarm conditions and component useful life guidance for 126 units distributed worldwide.
BAPS Shayona Sangam Katri Rose and nut fudge is recalled because it contains undeclared soy. The product was distributed to six states: Alabama, Florida, Georgia, North Carolina, South Carolina, and Tennessee.
Stryker Medical is recalling ProCuity bed series model 3009 due to missing electrical safety test values. The beds pose a risk of electrical shock or tissue burn to patients.
Fresenius Medical Care is updating the Stay Safe Cap's labeling to include additional warnings and contraindications for potential side effects. No illnesses have been reported.
Vermont Village Organic Unsweetened Apple Sauce (24oz) is being recalled due to elevated patulin levels. Consumers should not consume the product and should discard or return it.
Wilson-Cook Medical recalls 553 Quantum TTC Biliary Balloon Dilators that do not meet design specifications, creating risk of balloon detachment during endoscopic procedures.
Staar Surgical is recalling 15 EVO+VISIAN Implantable Collamer Lens devices due to potential specification failures. The devices may not meet design specifications.
Audi is recalling select 2019-2024 electric vehicles due to fire risk from overheating 220V/240V home charging cables. Owners should stop using the affected cables and switch to 110V charging or public stations until replacement cables with temperature sensors are supplied.
Atrium Oasis chest drain devices were re-sterilized by a third party using unapproved packaging and sterilization processes lacking manufacturer validation. Affected devices were distributed in Virginia.
Wilson-Cook Medical is recalling QUANTUM TTC biliary balloon dilators due to design non-conformance. The devices may detach during use, potentially requiring endoscopic retrieval that could cause bleeding.