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.
FUJIFILM is recalling Noblus AC Adapters nationwide due to fire and smoke hazard. The adapters can overheat and generate smoke when the power cable is repeatedly inserted and removed.
Philips is recalling 139 Ingenia 1.5T S MRI scanners due to a loose terminal connection in the power distribution unit that could create an electrical hotspot and cause smoke or fire. No injuries have been reported.
Medline 30mL non-sterile syringes (Model 83078) are recalled because their designs fall outside the FDA-cleared specifications. About 4.1 million units distributed in the U.S. are affected.
Jiangsu Shenli Medical Production Co., Ltd. is recalling Medline brand 10ML non-sterile syringes (Model 91874) because piston sizes and configurations exceed the range approved under the firm's FDA 510(k) clearance.
Philips is recalling its Upgrade dStream MR system due to a potential fire hazard. A loose terminal connection in the g-MDU may create a hotspot causing smoke or fire.
American Regent Inc. is recalling Vasopressin Injection nationwide because some vials are subpotent and contain out-of-specification impurities.
Philips has recalled 81 MR 5300 MRI systems worldwide due to a loose electrical connection that may overheat and cause fire or smoke in hospital technical rooms.
Philips Incisive CT scanner systems may have a defective metal mounting box that could fracture and expel fragments during operation. Eighteen units are affected nationwide.
Philips has recalled 81 Marlin 1.5T MR diagnostic systems due to a loose g-MDU terminal connection that may create a fire hazard in hospital technical rooms.
Medline non-sterile syringes (Model 91858) are recalled for manufacturing outside FDA-cleared specifications. The recall covers 50,400 units distributed nationwide.
Jiangsu Shenli Medical Production Co. recalls approximately 30,800 non-sterile Medline 10mL syringes because their sizes and configurations fall outside FDA-cleared scope. No injuries reported.
Ethicon recalls SURGIFOAM Absorbable Gelatin Powder Kit (Product Code 1979) due to open seals on applicator tips in three lots. The recall affects 5,184 units distributed nationwide.
Stryker Blueprint Software versions 2.1.4 to 4.0.2 contain a bug allowing incompatible implant configurations without regulatory approval. The software was distributed nationwide in FL, KY, NJ, and WI.
Jiangsu Shenli Medical is recalling Wolf Medical 60 mL Luer Lock piston syringes because they were manufactured outside the scope of the firm's FDA 510(k) clearance.
Siemens IMMULITE 2000 Anti-TG Ab thyroid test kits are recalled due to the potential for falsely elevated patient sample results. Affected lots may produce inaccurate results that could lead to misdiagnosis.
Olympus has recalled InstaClear Lens Sheaths used in rigid endoscopy because the distal end may break off during procedures. All lot numbers of multiple model variants distributed in the U.S. and internationally are affected.
Philips Evolution 1.5T MR systems may have loose g-MDU terminal connections that could create electrical hotspots and cause fires. The recall affects 56 units distributed worldwide.
Fresenius is recalling 12,292 BlueStar hemodialysis machines because the blood pump rotor component can develop loose or dislodged guide sheaves after clinical use. Patients should contact their healthcare provider to verify if their equipment is affected.
Jiangsu Shenli Medical recalled 3mL non-sterile syringes because they were manufactured outside the scope of FDA approval. The product was distributed nationwide across six U.S. states.
Jiangsu Shenli Medical has recalled Medline non-sterile syringes because manufactured sizes and configurations exceed the FDA-cleared scope. No illnesses or injuries have been reported.
Medline is recalling approximately 525,700 non-sterile 10mL syringes manufactured with sizes and configurations exceeding FDA-approved specifications. No injuries or illnesses have been reported.
A loose terminal connection in the power distribution unit of Philips Achieva 3.0T TX PET imaging systems may create an electrical hotspot, potentially causing smoke or fire. The device is distributed worldwide.
Jiangsu Shenli Medical is recalling non-sterile GMAX syringes for configurations that exceed FDA 510(k) clearance limits. Distributed nationwide, these devices pose infection risk.
Philips has recalled 200 SmartPath to dStream MR imaging systems worldwide due to a loose electrical connection in the g-MDU unit that may create a fire hazard in hospital technical rooms.
GMAX SYR 30ML/LL syringes manufactured by Jiangsu Shenli Medical have been recalled because their sizes and configurations exceed the FDA 510(k) specifications approved for these devices. The recall affects 1,117,500 units distributed nationwide.