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.
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.
Mentor is recalling the CPX 4 US Breast Tissue Expander with Suture Tabs, smooth low height 650 cc, because the infusion sets may contain a dull or blunt needle tip.
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.
Medline is recalling Thoracic Robots kits, model DYNJ908777B, because they contain recalled Olympus biopsy valves where rubber fragments may detach from the valve slit.
Civco is recalling the eTRAX Needle Sensor 16G for Aurora trackers because an inspection and programming error may cause the needle tip position to be incorrectly identified on the user interface.
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.
TG FOODS INC is recalling Divided Sunset Multi Collagen Peptides (8 oz) because the product contains eggshell membrane collagen and wild-caught marine collagen but fails to declare EGG and the specific fish species on the label.
Medtronic is recalling Paradigm REAL-Time Revel 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 Azurion 5 M20 because X-ray imaging may not be initiated, or may occur intermittently, when using the wired foot switch.
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 Texas is recalling Artoura Breast Tissue Expanders because the infusion sets may contain a dull or blunt needle tip that may be difficult to advance or may break.
JFE Franchising Inc is recalling three dumpling products due to possible glass fragments. Affected products include Dumpling Party Tray (20pcs and 40pcs) Vegetable varieties and Cheetos Flamin Hot Loaded Dumpling Vegetable.
Medtronic is recalling MiniMed 620G 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 MiniMed 700G insulin pumps because raising or lowering the pump relative to the infusion site can cause unintended over- or under-delivery of insulin.
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.
Civco is recalling the eTRAX Needle Sensor 14G for Aurora trackers because an inspection and programming error may cause the needle tip position to be incorrectly identified.
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.
Ultradent Products is recalling one lot of Jiffy Original Composite Polisher Cups because the cups may crumble and break apart easily, which could delay patient treatment.
Stryker is recalling the CHROMOPHARE Softlit Ring Surgical Light System because the light assembly may not adequately support the weight of the ceiling cover.
Intuitive Surgical is recalling da Vinci S and Si Mega Needle Driver Instruments following increased complaints of broken or frayed grip cables in reusable instruments.
Medline is recalling kits containing ENFit G-tube connectors because the connectors were not made to required dimensional specifications and may not form a proper seal.
Imu-Tek Animal Health is recalling Imu-Tek Colostrum-5 120 Capsules (Lot #013, Expiration 092826) because the product is potentially under-processed. The product was distributed across 29 states.
Burlington Medical is recalling leg wraps because of the potential for attenuation degradation over time, decreasing the lifespan of the product.
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.
Leader Artificial Tears 15 mL, containing polyvinyl alcohol and povidone, are being recalled for lack of assurance of sterility.