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.
Burlington Medical is recalling protective vests because of the potential for attenuation degradation over time, decreasing the lifespan of the garment.
A further quantity of Prazosin Hydrochloride tablets is being recalled after detection of the nitrosamine impurity N-nitroso-prazosin impurity C above acceptable limits.
Recor Medical is recalling one lot of the Paradise Ultrasound Renal Denervation System Catheter because a nonconforming product that should have been scrapped was distributed instead.
The 2.4 VOLT Tap Locking Screw Tap is being recalled after a full lot swap with the Cortical Screw Tap left the bone taps with an incorrect thread.
One lot of Sterile Radiology Procedure Kits, model DYNDH1491B, is being recalled because of a potential breach in the sterile pouch packaging that may compromise sterility.
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.
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.
Civco is recalling the eTRAX Needle Sensor 12G 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 FD20/15 OR Table because X-ray imaging may not be initiated, or may occur intermittently, when using the wired foot switch.
Intuitive Surgical is recalling da Vinci S and Si Grasping Retractor Instruments following increased complaints of broken or frayed grip cables in reusable instruments.
Olympus is recalling SOLTIVE Pro SuperPulsed Laser Systems because a potential defect in the 24V power supply module may render the system inoperable and produce smoke or a burning smell.
Philips is recalling the Allura Xper FD10 OR Table because X-ray imaging may not be initiated, or may occur intermittently, when using the wired foot switch.
Philips is recalling the Azurion 7 M12 because X-ray imaging may not be initiated, or may occur intermittently, when using the wired foot switch.
Burlington Medical is recalling thyroid shields over the potential for attenuation degradation over time, which decreases the product's usable lifespan. 41,962 units are affected.
Philips is recalling Vue Motion V12 because mis-ordered frames during dynamic cine runs may cause image frames to display out of sequence.
Medtronic is recalling MiniMed 780G insulin pumps because raising or lowering the pump relative to the infusion site can cause unintended over- or under-delivery of insulin.
Philips is recalling the Allura Xper FD10F because X-ray imaging may not be initiated, or may occur intermittently, when using the wired foot switch.
Mentor is recalling CPX 4 US Breast Tissue Expanders with Suture Tabs in the smooth tall height range because the infusion sets may contain a dull or blunt needle tip.
Mentor is recalling CPX 4 US Breast Tissue Expanders with Suture Tabs in the smooth medium height range because the infusion sets may contain a dull or blunt needle tip.
Burlington Medical is recalling wrap aprons made with Xenolite 800 attenuation material because of the potential for attenuation degradation over time.
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.
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.
Philips is recalling the Azurion 7 B12 because X-ray imaging may not be initiated, or may occur intermittently, when using the wired foot switch.
Philips is recalling the Azurion 3 M12 because X-ray imaging may not be initiated, or may occur intermittently, when using the wired foot switch.
Philips is recalling the Allura Xper FD10C because X-ray imaging may not be initiated, or may occur intermittently, when using the wired foot switch.