AVID is removing bags from Organ Recovery and Medical Convenience Kits due to the bags being made of non-medical grade Poly and lacking intact seals.
AVID is removing bags from Organ Recovery and Medical Convenience Kits due to the bags being made of non-medical grade Poly and lacking intact seals.
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
This communication is part of the Communications Pilot to Enhance the Medical Device Recall Program
Some Ivenix LVP Primary Administration Sets were assembled with the drip chamber and Luer Lock components in reversed positions, potentially leading to clinical complications
This communication is part of the Communications Pilot to Enhance the Medical Device Recall Program
Alcon recalls Custom Pak Ophthalmic Procedure Packs due to incomplete seals that may compromise sterility. Check lot numbers, recall instructions.?
GE HealthCare issues updated use instructions for certain Carestation 600 and 700 series Anesthesia Systems
ICU Medical removes IV Gravity Burette Set due to the burette component missing an internal shut-off valve intended to stop fluid flow.
A defect was discovered in the Dexcom G6 and G6 Pro Android US CGM App version 1.15.0 that may cause the app to shut down unexpectedly.
Cook Medical is removing certain ZENITH ALPHA 2 THORACIC ENDOVASCULAR GRAFT proximal components because PTFE scrapings may enter the stent graft during deployment.
Drager is removing affected ErgoStar Cather Mounts due to cracks in the hose.
Integra LifeSciences is removing certain lots of Microsensor and Cerelink ICP Kits with potential corrosion stains on the included Tuohy Needle.
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
IMPRIS corrects IMRIS Neuro III-SV models due to the potential of ice blockage in the helium venting pipe
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
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...
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.
GE HealthCare issues updated use instructions for certain Carestation 600 and 700 series Anesthesia Systems
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,...
Olympus ligation loops may be unable to release or detach as expected during use and may become unintentionally anchored around patient anatomy
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