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ICU Medical removes IV Gravity Burette Set due to the burette component missing an internal shut-off valve intended to stop fluid flow.View the full article

GE HealthCare issues updated use instructions for certain Carestation 600 and 700 series Anesthesia SystemsView the full article

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.View the full article

Gold Star Distribution, Inc. (Gold Star or “the Company”) is recalling all FDA regulated products listed in this press release due to the presence of rodent and avian contamination.View the full article

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

Cook Medical is removing certain ZENITH ALPHA 2 THORACIC ENDOVASCULAR GRAFT proximal components because PTFE scrapings may enter the stent graft during deployment. View the full article

Integra LifeSciences is removing certain lots of Microsensor and Cerelink ICP Kits with potential corrosion stains on the included Tuohy Needle.View the full article

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 View the full article

IMPRIS corrects IMRIS Neuro III-SV models due to the potential of ice blockage in the helium venting pipeView the full article

This communication is part of the Communications Pilot to Enhance the Medical Device Recall ProgramView the full article

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 11,100View the full article

This communication is part of the Communications Pilot to Enhance the Medical Device Recall ProgramView the full article

This communication is part of the Communications Pilot to Enhance the Medical Device Recall ProgramView the full article

This communication is part of the Communications Pilot to Enhance the Medical Device Recall Program View the full article

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 thromboembolicView the full article

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. View the full article

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, View the full article

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 dysView the full article

GE HealthCare issues updated use instructions for certain Carestation 600 and 700 series Anesthesia SystemsView the full article

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, aView the full article

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

Certain Abbott Diabetes Care Continuous Glucose Monitor sensors may provide incorrect low glucose readingsView the full article

Certain SJM Pericardial Patches from Glycar SA may not meet the required tensile strength specificationView the full article