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.
Philips is recalling the Allura Xper FD10 because X-ray imaging may not be initiated, or may occur intermittently, when using the wired foot switch.
Burlington Medical is recalling protective vests because of the potential for attenuation degradation over time, decreasing the lifespan of the garment.
Siemens is recalling Atellica CH Enzymatic Hemoglobin A1c because results may be depressed when the RCRP reagent is processed on the same analyzer, with bias increasing over time.
Civco is recalling the eTRAX Needle System Starter Kit 16G for Aurora trackers because an inspection and programming error may cause the needle tip position to be incorrectly identified.
Mentor is recalling Artoura Breast Tissue Expanders in the smooth ultra high profile range because the infusion sets may contain a dull or blunt needle tip.
Intuitive Surgical is recalling da Vinci S and Si Tenaculum Forceps Instruments following increased complaints regarding frayed or broken pitch cables on reusable surgical instruments.
Medtronic is recalling Paradigm REAL-Time insulin pumps because raising or lowering the pump relative to the infusion site can cause unintended over- or under-delivery of insulin.
Burlington Medical is recalling demi half aprons because of the potential for attenuation degradation over time, decreasing the lifespan of the product.
Medtronic is recalling MiniMed 530G insulin pumps because raising or lowering the pump relative to the infusion site can cause unintended over- or under-delivery of insulin.
Civco is recalling the eTRAX Needle Sensor 18G for Aurora trackers because an inspection and programming error may cause the needle tip position to be incorrectly identified.
Philips is recalling the Allura Xper FD10/10 because X-ray imaging may not be initiated, or may occur intermittently, when using the wired foot switch.
Medline is recalling three bronchoscopy convenience kits because they contain recalled Olympus biopsy valves, where rubber fragments may detach from the valve slit during use.
Philips is recalling the Allura Xper FD20/15 because X-ray imaging may not be initiated, or may occur intermittently, when using the wired foot switch.
Stryker is recalling the CHROMOPHARE Softlit Ring Surgical Light System because the light assembly may not adequately support the weight of the ceiling cover.
Philips is recalling the Allura Xper FD20/15 OR Table because X-ray imaging may not be initiated, or may occur intermittently, when using the wired foot switch.
Medline is recalling Thoracic Robots kits, model DYNJ908777B, because they contain recalled Olympus biopsy valves where rubber fragments may detach from the valve slit.
Intuitive Surgical is recalling da Vinci S and Si Double Fenestrated Grasper Instruments following increased complaints of broken or frayed grip cables in reusable instruments.
Philips is recalling the Allura Xper FD20/20 because X-ray imaging may not be initiated, or may occur intermittently, when using the wired foot switch.
Medtronic is recalling MiniMed 640G insulin pumps because raising or lowering the pump relative to the infusion site can cause unintended over- or under-delivery of insulin.
Medtronic is recalling Paradigm insulin pumps models MMT-712 and MMT-715 because raising or lowering the pump relative to the infusion site can cause unintended over- or under-delivery of insulin.
The Finesse BTK Multicath injectable angioplasty balloon catheter is being recalled because of the potential for the balloon not to meet burst specifications.
Philips is recalling the Allura Xper FD20 Biplane OR Table because X-ray imaging may not be initiated, or may occur intermittently, when using the wired foot switch.
Philips is recalling the Allura Xper FD20 because X-ray imaging may not be initiated, or may occur intermittently, when using the wired foot switch.
Mentor is recalling textured Artoura Breast Tissue Expanders with integral injection dome because the infusion sets may contain a dull or blunt needle tip.
Medtronic is recalling MiniMed 720G insulin pumps because raising or lowering the pump relative to the infusion site can cause unintended over- or under-delivery of insulin.