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.
Quanta System is recalling Olympus Sterile Optical Laser Fibers nationwide due to potentially compromised sterility. Approximately 26,925 units distributed through six U.S. distributors are affected.
Alphatec Spine is recalling the Atec Insignia Anterior Cervical Plate System because the screw blocking mechanism could disassociate or unlock during or after cervical spine surgery.
Brainlab's ExacTrac Dynamic radiotherapy positioning software may delay display of patient movement during high-dose treatments, risking treatment precision errors. 22 systems affected across 11 U.S. states.
Alphatec Spine recalls its Insignia Anterior Cervical Plate System because the screw blocking mechanism may disassociate during spinal surgery or unlock afterward. Healthcare providers should contact the manufacturer for guidance.
Alphatec Spine's Atec Insignia anterior cervical plate system has a defect in the screw blocking mechanism that could disassociate or unlock during or after surgery.
Alphatec Spine Inc. is recalling the Atec Insignia anterior cervical plate system because the screw blocking mechanism may disassociate intraoperatively or unlock postoperatively. No injuries reported.
The Alphatec Insignia anterior cervical plate system may have a defect where the screw blocking mechanism disassociates during surgery or unlocks afterward. Consult your doctor if you have this implant.
Whole Foods Market Organic Dark Red Kidney Beans are being recalled because they contain undeclared allergens: wheat, soy, and milk. Consumers with allergies to these ingredients should not consume the product.
Alphatec Spine is recalling the Insignia Anterior Cervical Plate System due to a potential failure in the screw locking mechanism. The mechanism may disassociate or unlock during or after spinal surgery.
The FDA is recalling certain Atec Insignia Anterior Cervical Plate Systems due to a potential defect in the screw blocking mechanism that could disassociate or unlock during or after surgery.
Alphatec Spine is recalling the Atec Insignia Anterior Cervical Plate System due to a potential defect in the screw blocking mechanism. The screws may disassociate or unlock during or after surgery, risking implant failure.
DePuy Orthopaedics recalled 50 hip prostheses with incorrect part numbers and sizes etched on the devices. The affected Lot D20111130 was distributed domestically and to Bermuda.
The Alphatec Insignia Anterior Cervical Plate System is recalled because the screw blocking mechanism may disassociate intraoperatively or unlock postoperatively. Eight units were distributed across 15 U.S. states.
Alphatec is recalling its Insignia Anterior Cervical Plate System due to potential screw blocking mechanism failure during or after spinal surgery. The screw may disassociate intraoperatively or unlock postoperatively.
Alphatec Spine's Insignia Anterior Cervical Plate System may have a defective screw blocking mechanism that could disassociate during or after surgery. The FDA has recalled 19 units distributed across 15 US states.
Nico Corp. is recalling 80 Myriad-LX Light Source units due to potential burn injury to patients from the distal tip of the fiber assembly and risk of delivery sleeve occlusion during surgical use.
Alphatec Insignia Anterior Cervical Plate System screw blocking mechanism may disassociate during surgery or unlock afterward. No injuries reported.
Wishbone Medical is recalling WishBone Medical Plate and Screw System implants due to nonconformities in engineering specifications. The recall affects 60 units distributed in Virginia, Pennsylvania, and Indiana.
Sunstar Americas is recalling SUNSTAR G.U.M PERIOSHIELD Oral Health Rinse 300mL (SKU 1775P, 1775R) due to potential contamination with Burkholderia bacteria.
Alphatec Spine is recalling its Insignia Anterior Cervical Plate System due to potential failure of the screw blocking mechanism during or after surgery that could compromise implant stability.
Alphatec Spine is recalling the Insignia Anterior Cervical Plate System because the screw blocking mechanism may disassociate during or after spinal surgery.
Alphatec Spine is recalling the Atec Insignia Anterior Cervical Plate System due to potential failure of the screw blocking mechanism that could cause separation during or after surgery.
Alphatec Spine is recalling the Insignia Anterior Cervical Plate System due to a potential defect in the screw blocking mechanism that could disassociate or unlock during or after surgery.
Quanta System Sterile Optical Laser Fiber units are being recalled because product sterility may be compromised, posing a potential safety risk during medical procedures.
Alphatec Spine recalled the Atec Insignia Anterior Cervical Plate System due to potential failure of the screw blocking mechanism, which could disassociate during or after surgery.