Unofficial FDA Medwatch Safety Alerts Bot
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Posts from the FDA Medwatch Safety Alerts. Not affiliated with the FDA. Bot will update once/day at midnight CST. For any questions, feature requests, or bug reports, please reach out to
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@davidw1457.bsky.social
Description: ICU Medical removes IV Gravity Burette Set due to the burette component missing an internal shut-off valve intended to stop fluid flow.
December 31, 2025 at 6:00 AM
Description: ICU Medical removes IV Gravity Burette Set due to the burette component missing an internal shut-off valve intended to stop fluid flow.
Link: http://www.fda.gov/medical-devices/medical-device-recalls-and-early-alerts/intravascular-administration-set-recall-icu-medical-removes-iv-gravity-burette-set
Date: 2025-12-30
Date: 2025-12-30
December 31, 2025 at 6:00 AM
Description: GE HealthCare issues updated use instructions for certain Carestation 600 and 700 series Anesthesia Systems
December 31, 2025 at 6:00 AM
Description: GE HealthCare issues updated use instructions for certain Carestation 600 and 700 series Anesthesia Systems
Link: http://www.fda.gov/medical-devices/medical-device-recalls-and-early-alerts/anesthesia-system-correction-ge-healthcare-updates-use-instructions-carestation-anesthesia-systems
Date: 2025-12-30
Date: 2025-12-30
December 31, 2025 at 6:00 AM
Description: 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.
December 30, 2025 at 6:00 AM
Description: 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.
Link: http://www.fda.gov/medical-devices/medical-device-recalls-and-early-alerts/continuous-glucose-monitoring-software-correction-dexcom-issues-correction-dexcom-g6-and-g6-pro
Date: 2025-12-29
Date: 2025-12-29
December 30, 2025 at 6:00 AM
Description: 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.
December 27, 2025 at 6:00 AM
Description: 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.
Link: http://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/gold-star-distribution-inc-issues-recall-certain-fda-regulated-products-three-states-including-drugs
Date: 2025-12-26
Date: 2025-12-26
December 27, 2025 at 6:00 AM
Description: Drager is removing affected ErgoStar Cather Mounts due to cracks in the hose.
December 24, 2025 at 6:00 AM
Description: Drager is removing affected ErgoStar Cather Mounts due to cracks in the hose.
Link: http://www.fda.gov/medical-devices/medical-device-recalls-and-early-alerts/catheter-mount-recall-draeger-removes-ergostar-catheter-mounts
Date: 2025-12-23
Date: 2025-12-23
December 24, 2025 at 6:00 AM
Description: Cook Medical is removing certain ZENITH ALPHA 2 THORACIC ENDOVASCULAR GRAFT proximal components because PTFE scrapings may enter the stent graft during deployment.
December 24, 2025 at 6:00 AM
Description: Cook Medical is removing certain ZENITH ALPHA 2 THORACIC ENDOVASCULAR GRAFT proximal components because PTFE scrapings may enter the stent graft during deployment.
Link: http://www.fda.gov/medical-devices/medical-device-recalls-and-early-alerts/endovascular-graft-recall-cook-medical-removes-zenith-alpha-2-thoracic-endovascular-graft
Date: 2025-12-23
Date: 2025-12-23
December 24, 2025 at 6:00 AM
Description: Integra LifeSciences is removing certain lots of Microsensor and Cerelink ICP Kits with potential corrosion stains on the included Tuohy Needle.
December 24, 2025 at 6:00 AM
Description: Integra LifeSciences is removing certain lots of Microsensor and Cerelink ICP Kits with potential corrosion stains on the included Tuohy Needle.
Link: http://www.fda.gov/medical-devices/medical-device-recalls-and-early-alerts/early-alert-convenience-kit-needle-issue-integra-lifesciences
Date: 2025-12-23
Date: 2025-12-23
December 24, 2025 at 6:00 AM
Description: 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
December 24, 2025 at 6:00 AM
Description: 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
Link: http://www.fda.gov/medical-devices/medical-device-recalls-and-early-alerts/mri-system-correction-siemens-healthineers-issues-correction-3-tesla-mri-systems
Date: 2025-12-23
Date: 2025-12-23
December 24, 2025 at 6:00 AM
Description: IMPRIS corrects IMRIS Neuro III-SV models due to the potential of ice blockage in the helium venting pipe
December 24, 2025 at 6:00 AM
Description: IMPRIS corrects IMRIS Neuro III-SV models due to the potential of ice blockage in the helium venting pipe