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.
Ascend Laboratories is recalling 135 bottles of Aripiprazole 20 mg tablets nationwide due to failure of spectroscopic identification testing, indicating the product may not meet established quality standards.
Bakery Barn has recalled Tried and True Granola products due to undeclared milk allergen. The recall affects 690 units distributed to retailers in Ohio and Pennsylvania.
Boston Scientific recalls the Habib EndoHPB Bipolar RF Catheter used in pancreatic and biliary procedures due to inaccurate instructions that could result in excessive energy delivery and thermal injury.
Philips is recalling 2D Perfusion diagnostic imaging software due to signal processing errors that can produce inaccurate presentations, potentially affecting clinical decisions.
The FDA is recalling the Tobii Dynavox TD I-110, a speech-generating device, because the battery may become loose from its housing and potentially be damaged. This affects users worldwide who depend on this device for communication.
BMW is recalling 2023 X7 and XM models due to improperly tightened fasteners connecting the exhaust system to the catalytic converter, which could increase fire risk. Dealers will replace the gasket and tighten fasteners at no charge.
Radiometer is recalling AQURE laboratory software versions 2.5.2 through 2.6.1 due to a potential issue that could cause patient data mix-ups.
Victoria Gourmet's Natural Pak Bacon Glaze packages labeled and sold in Ohio actually contain Coffee Chili Rub with undeclared ingredients including mustard, an allergen.
Baxter Healthcare Corporation is recalling the ExactaMed 20 mL Oral Dispenser (Lot B301S356P) because it may contain particulate matter. The recall affects approximately 91,100 units distributed in the US.
NeuroLogica Corporation recalls 935 Samsung GM85 digital X-ray systems due to a faulty arm latch in the column support that could allow the arm to fall, creating a risk of bodily injury.
Medline Industries is recalling 162 units of Centurion CirClamp surgical devices due to incorrect subassembly size. The defect could affect proper device function during surgical use.
Medacta USA is recalling MectaLIF ANTERIOR interbody fusion devices due to a potential for breakage of a small screw that secures the anti-backout plate. The defect affects 44 units distributed across five US states.
Olympus is recalling single-use rotatable clip fixing devices used in endoscopy procedures. The clips may fail to deploy from the tube sheath during use.
Medacta Usa Inc is recalling MectaLIF ANTERIOR antibackout lag covers due to potential breakage of the small screw that affixes the anti-backout plate. The defect affects spinal fusion procedures in select US states.
2023 Genesis GV60 vehicles with all-wheel drive may have rear driveshafts that fracture, resulting in loss of drive power and increased crash risk. Hyundai will replace the affected driveshafts at no cost to owners.
Smith & Nephew is recalling 12 JOURNEY II UNI Tibia Insert components due to a manufacturing mispack. Some boxes incorrectly contain a different size component.
Vital Care Compounder is recalling C-Semaglutide 5mg/mL injection in 0.5mL vials due to lack of assurance of sterility. The recall affects 45 vials distributed in Mississippi.
Medacta's MectaLIF ANTERIOR fusion device is being recalled due to potential breakage of a small screw used to affix the anti-backout plate. The recall affects 17 units distributed across the US.
Medtronic is recalling INFINITY spinal implant screws manufactured with incorrect titanium material. The defect reduces the screw's gripping strength, risking implant performance in critical spinal fusion surgery.
BD Kiestra InoqulA+ (software versions 5.1/5.1.1) fails to display plate information after processing in clinical laboratories, risking diagnostic delays or specimen recollection.
Medtronic is recalling 10 units of INFINITY Multi-Axial Screws distributed in the US and Canada because incorrect titanium material reduces gripping strength in affected lots.
Medacta Usa Inc is recalling the MectaLIF ANTERIOR interbody fusion device due to potential breakage of the small screw that affixes the anti-backout plate. The recall affects 34 units distributed in the United States.
Beckman Coulter is recalling Access Free T3 reagent test kits (Catalog #A13422, Lot #233968) because approximately 15-20% of samples produce falsely elevated results that could lead to misdiagnosis and inappropriate thyroid treatment.
Natural Solutions Foundation is recalling a colloidal silver dietary supplement labeled to treat COVID-19. The product violates FDA regulations prohibiting disease claims on dietary supplements.
Subaru is recalling certain 2023 Impreza vehicles due to a faulty brake light switch that may illuminate brake lights without pedal application and allow the transmission to shift out of PARK without pressing the brake pedal, creating rollaway and crash risk.