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.
Zimmer Biomet is recalling 3 units of Oxford Partial Knee Phase 3 Femoral Drill Guides because incorrect raw materials may cause corrosion.
Stryker is recalling High Flow II Tube Sets because they consistently leak and detach from the cassette. The product is a medical device accessory distributed nationwide and internationally.
AngioDynamics is recalling 178 Solero Microwave Tissue Ablation System generators to update manuals and software, reducing the risk of patient harm from procedure delays.
Flowonix Medical Inc is recalling Prometra Clinician Programmer software due to a defect that can cause intrathecal pumps to shut down unexpectedly.
Zimmer Biomet is recalling 10 units of Oxford Partial Knee Phase 3 Femoral Drill Guides because incorrect raw material was used, potentially leading to corrosion.
Philips is recalling IntelliVue MX40 Patient Monitors because they may fail to provide visual or audible alerts when the battery is low.
AngioDynamics is recalling Solero Microwave Tissue Ablation System applicators to reduce the risk of patient harm from delayed procedures via manual and software updates.
Philips is recalling IntelliVue MX40 Patient Monitors because they may consume excess power and fail to provide visual or audible low-battery alerts.
Topnotch Foods Inc. is recalling 10 lb. bags of Italian Bread Crumbs found to contain undeclared soy lecithin during a California Department of Public Health inspection.
Accuray is recalling 68 CyberKnife M6 systems because an interlock interruption during automated housing exchange can cause the secondary collimator housing to drop.
Flowonix Medical Inc. is recalling 809 Prometra Programmable Pumps because a software defect can cause the pump to shut down unexpectedly.
Stryker is recalling High Flow Tube Sets with Real-Time Pressure Sensing because they consistently leak and detach from the cassette.
Stryker Neurovascular is recalling AXS Infinity LS Plus Long Sheaths because a design issue can cause the device to become brittle and fracture.
Zimmer Biomet is recalling 14 units of Oxford Partial Knee Phase 3 Femoral Drill Guides because incorrect raw materials were used, potentially leading to corrosion.
Mares is recalling XR buoyancy compensation vests because the deflation button can unscrew, causing loss of buoyancy and a drowning hazard. No injuries have been reported.
Philips is recalling IntelliVue MX40 Patient Monitors because they may fail to provide visual or audible low-battery alerts, potentially disrupting patient monitoring.
Accuray is recalling 43 CyberKnife VSI systems because an interlock interruption during automated housing exchange can cause the secondary collimator housing to drop.
Stryker is recalling 19,083 boxes of Heated Tube Sets with Real-Time Pressure Sensing because they consistently leak and detach from the cassette.
AngioDynamics is recalling 314 Solero Microwave Tissue Ablation System generators to update manuals and software, reducing the risk of patient harm from procedure delays.
AngioDynamics is recalling 1,846 Solero Microwave Tissue Ablation System applicators to reduce the risk of patient harm from procedure delays.
Microline Surgical is recalling 115 TLS2 Thermal Ligating Shears because they fail to actuate, preventing them from performing their intended surgical function.
Centurion Medical Products Corporation is recalling sterile nail clippers because the sterile barrier pouch seals are compromised, potentially affecting sterility.
Young Ocean is recalling Seasoned Alaskan Pollock Roe because the label fails to declare bonito and lactose (milk) as ingredients.
Cook Inc. is recalling 83 Pericardiocentesis Catheter Sets because the catheter distal end hole may be too small.
Zimmer Biomet is recalling 41 Oxford Partial Knee Phase 3 Femoral Drill Guides because incorrect raw material was used in the screw component, which could lead to corrosion.