Drager is removing affected ErgoStar Cather Mounts due to cracks in the hose.

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

FOR IMMEDIATE RELEASE – December 10, 2025 – Albuquerque, New Mexico, MediNatura New Mexico, Inc. is voluntarily recalling one lot 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, a

GE HealthCare issues updated use instructions for certain Carestation 600 and 700 series Anesthesia Systems

Olympus ligation loops may be unable to release or detach as expected during use and may become unintentionally anchored around patient anatomy
 

Certain Abbott Diabetes Care Continuous Glucose Monitor sensors may provide incorrect low glucose readings

Certain SJM Pericardial Patches from Glycar SA may not meet the required tensile strength specification

Dropping or severely jarring Alaris Pumps may damage critical pump components. Do not use dropped or jarred devices until thoroughly inspected and tested