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.
Hayneedle is recalling Shorea Wooden Arc Hammock Stands because the wood layers can separate, causing the stand to break and posing a fall hazard.
ThyssenKrupp Access Manufacturing is recalling LEV II, Volant, and Rise residential elevators because the door can open without the car present, posing a fall risk.
Custom Medical Specialties is recalling PVP Prep Solution kits because the manufacturer did not perform required microbial testing, meaning the product may not meet specifications.
Exactech is recalling two Novation Modular Drill Bits because they were reported to have been used in a non-sterile condition.
Intuitive Surgical is recalling 11,121 boxes of disposable tip covers for 8mm monopolar curved scissors due to potential sterility compromise.
Exactech is recalling two Novation Modular Drill Bits because they were reported to have been used in a non-sterile condition.
Exactech is recalling two Novation Modular Drill Bits because they were reported to have been used in a non-sterile condition.
Omni Life Science is recalling 182 units of the Apex Knee System Modular Tibia Augment because the sterile pouches may breach, compromising sterility.
C.R. Bard is recalling 56,694 units of Bard Foley procedural trays because the sterile packaging seals were incomplete.
Exactech is recalling two Novation Modular Drill Bits because they were reported to have been used in a non-sterile condition.
Medtronic Xomed is recalling seven NIM 3.0 Patient Interfaces because they may fail to detect electrode signal loss, potentially delaying surgical procedures.
Hospira is recalling sterile empty vials and injectors because they may leak during filling and administration. The recall covers products distributed in the US, Canada, Costa Rica, and the Virgin Islands.
Omni Life Science is recalling 286 Apex Knee System Modular Tibia Augments because the sterile pouches may breach, compromising sterility.
Biosense Webster is recalling 71 CARTO 3 V1.05 systems because a potential hazard may occur when used with Bloom EP Stimulators and other electrophysiology equipment.
Custom Medical Specialties is recalling CMS-8412-R2 Custom Cysto Packs because the manufacturer did not perform required microbial testing, causing the product to fail finished goods specifications.
Custom Medical Specialties is recalling CMS-2981-R3 Arthrogram Trays because the manufacturer did not perform microbial testing, causing the product to fail finished goods specifications.
Omni Life Science is recalling 36 units of Apex Knee System Modular Tibia Augments because the sterile packaging may breach, compromising sterility.
Medtronic Xomed is recalling NIM 3.0 Patient Interfaces due to a trend of open channel conditions causing signal loss from the electrode.
Terumo is recalling eight Sarns Modular Perfusion System 8000 safety monitors due to an underrated circuit breaker that may cause the device to trip off.
Medtronic is recalling NIM 3.0 Patient Interfaces due to a trend of open channel conditions causing signal loss and potential surgical delays.
Exactech is recalling two Novation Modular Drill Bits because they were reported to have been used in a non-sterile condition.
JK Products & Services is recalling 1,948 Sun|Dash Radius 252 tanning systems because a door cord failure can cause a short in the wiring.
Omni Life Science is recalling 270 Apex Knee System Modular Tibia Augments because the sterile pouches may breach, compromising sterility.
Aesculap Implant Systems LLC is recalling S4 Element 4.5mm Polyaxial Screws because the screw channel may be out of tolerance, potentially preventing the screw head from locking to the bone.
GE Healthcare is recalling 254 Optima XR200amx mobile X-ray units in the US because a software defect allows exposures without displaying technique factors.