Cook Medical is removing certain ZENITH ALPHA 2 THORACIC ENDOVASCULAR GRAFT proximal components because PTFE scrapings may enter the stent graft during deployment.
IMPRIS corrects IMRIS Neuro III-SV models due to the potential of ice blockage in the helium venting pipe
Siemens Healthineers is correcting 3 Tesla MRI systems including MAGNETOM and BioGraph mMR due to the potential for ice blockage in the magnet venting system
Integra LifeSciences is removing certain lots of Microsensor and Cerelink ICP Kits with potential corrosion stains on the included Tuohy Needle.
This communication is part of the Communications Pilot to Enhance the Medical Device Recall Program
Handelnine Global Limited d/b/a Navafresh is voluntarily recalling Lot Numbers CAM040 & CALO79-N of Rheumacare Capsules by Virgo UAP Pharma Pvt. Ltd. (Virgo) to the consumer level. In test conducted by the Food and Drug Administration the product has been found to contain lead at levels up to 11,100
This communication is part of the Communications Pilot to Enhance the Medical Device Recall Program
This communication is part of the Communications Pilot to Enhance the Medical Device Recall Program
This communication is part of the Communications Pilot to Enhance the Medical Device Recall Program
Since approval, the FDA has received postmarketing safety data on thromboembolic events, including serious and fatal outcomes, in patients treated with Andexxa (coagulation factor Xa (recombinant), inactivated-zhzo). Based on available data, the serious risks including the increase in thromboembolic
Center Valley, Pa., (December 5, 2025)-Olympus Corporation today announced a voluntary medical device corrective action for its Single-Use Ligating Device ("Polyloop") following identification of a potential safety issue.
FOR IMMEDIATE RELEASE – December 16, 2025 – Albuquerque, New Mexico, MediNatura New Mexico, Inc. is voluntarily recalling all lots of ReBoost Nasal Spray to the consumer level. The product has been found to contain yeast/mold and microbial contamination with one species identified as Achromobacter,
Huntsville, Texas — StuffbyNainax LLC is voluntarily recalling all lots of MR.7 SUPER 700000 capsules to the consumer level. FDA analysis has found the product to be tainted with sildenafil and tadalafil, which are active ingredients in FDA-approved prescription drugs used to treat male erectile dys
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