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
@davidw1457.bsky.social
@davidw1457.bsky.social
Description: Some Ivenix LVP Primary Administration Sets were assembled with the drip chamber and Luer Lock components in reversed positions, potentially leading to clinical complications
January 6, 2026 at 6:00 AM
Description: Some Ivenix LVP Primary Administration Sets were assembled with the drip chamber and Luer Lock components in reversed positions, potentially leading to clinical complications
Link: http://www.fda.gov/medical-devices/medical-device-recalls-and-early-alerts/infusion-pump-recall-fresenius-kabi-removes-ivenix-large-volume-pumps
Date: 2026-01-05
Date: 2026-01-05
January 6, 2026 at 6:00 AM
Infusion Pump Recall: Fresenius Kabi Removes Ivenix Large Volume Pumps
January 6, 2026 at 6:00 AM
Infusion Pump Recall: Fresenius Kabi Removes Ivenix Large Volume Pumps
Description: This communication is part of the Communications Pilot to Enhance the Medical Device Recall Program
January 6, 2026 at 6:00 AM
Description: This communication is part of the Communications Pilot to Enhance the Medical Device Recall Program
Link: http://www.fda.gov/medical-devices/medical-device-recalls-and-early-alerts/aspiration-system-correction-calyxo-updates-use-instructions-cvac-aspiration-systems
Date: 2026-01-05
Date: 2026-01-05
January 6, 2026 at 6:00 AM
Aspiration System Correction: Calyxo Updates Use Instructions for CVAC Aspiration Systems
January 6, 2026 at 6:00 AM
Aspiration System Correction: Calyxo Updates Use Instructions for CVAC Aspiration Systems
Description: This communication is part of the Communications Pilot to Enhance the Medical Device Recall Program
January 6, 2026 at 6:00 AM
Description: This communication is part of the Communications Pilot to Enhance the Medical Device Recall Program
Link: http://www.fda.gov/medical-devices/medical-device-recalls-and-early-alerts/esophageal-ph-monitoring-capsule-recall-medtronic-and-given-imaging-remove-bravo-cf-capsule-delivery
Date: 2026-01-05
Date: 2026-01-05
January 6, 2026 at 6:00 AM
Esophageal pH Monitoring Capsule Recall: Medtronic and Given Imaging Remove Bravo CF Capsule Delivery Devices
January 6, 2026 at 6:00 AM
Esophageal pH Monitoring Capsule Recall: Medtronic and Given Imaging Remove Bravo CF Capsule Delivery Devices
Description: This communication is part of the Communications Pilot to Enhance the Medical Device Recall Program
January 6, 2026 at 6:00 AM
Description: This communication is part of the Communications Pilot to Enhance the Medical Device Recall Program
Link: http://www.fda.gov/medical-devices/medical-device-recalls-and-early-alerts/diagnostic-intravascular-catheter-recall-conavi-removes-novasight-hybrid-catheters
Date: 2026-01-05
Date: 2026-01-05
January 6, 2026 at 6:00 AM
Diagnostic Intravascular Catheter Recall: Conavi Removes Novasight Hybrid Catheters
January 6, 2026 at 6:00 AM
Diagnostic Intravascular Catheter Recall: Conavi Removes Novasight Hybrid Catheters
Description: This communication is part of the Communications Pilot to Enhance the Medical Device Recall Program
January 6, 2026 at 6:00 AM
Description: This communication is part of the Communications Pilot to Enhance the Medical Device Recall Program
Link: http://www.fda.gov/medical-devices/medical-device-recalls-and-early-alerts/infusion-pump-software-recall-baxter-removes-sigma-spectrum-infusion-system-platforms
Date: 2026-01-05
Date: 2026-01-05
January 6, 2026 at 6:00 AM
Infusion Pump Software Recall: Baxter Removes Sigma Spectrum Infusion System Platforms
January 6, 2026 at 6:00 AM
Infusion Pump Software Recall: Baxter Removes Sigma Spectrum Infusion System Platforms
Description: This communication is part of the Communications Pilot to Enhance the Medical Device Recall Program
January 6, 2026 at 6:00 AM
Description: This communication is part of the Communications Pilot to Enhance the Medical Device Recall Program
Link: http://www.fda.gov/medical-devices/medical-device-recalls-and-early-alerts/intravascular-picc-catheter-recall-bard-removes-powerpicc-intravascular-catheters
Date: 2026-01-05
Date: 2026-01-05
January 6, 2026 at 6:00 AM
Intravascular PICC Catheter Recall: Bard Removes PowerPICC Intravascular Catheters
January 6, 2026 at 6:00 AM
Intravascular PICC Catheter Recall: Bard Removes PowerPICC Intravascular Catheters
Description: Alcon recalls Custom Pak Ophthalmic Procedure Packs due to incomplete seals that may compromise sterility. Check lot numbers, recall instructions.
January 3, 2026 at 6:00 AM
Description: Alcon recalls Custom Pak Ophthalmic Procedure Packs due to incomplete seals that may compromise sterility. Check lot numbers, recall instructions.
Link: http://www.fda.gov/medical-devices/medical-device-recalls-and-early-alerts/custom-surgical-pack-recall-alcon-removes-custom-pak-ophthalmic-procedure-packs
Date: 2026-01-02
Date: 2026-01-02
January 3, 2026 at 6:00 AM
Custom Surgical Pack Recall: Alcon Removes Custom Pak Ophthalmic Procedure Packs
January 3, 2026 at 6:00 AM
Custom Surgical Pack Recall: Alcon Removes Custom Pak Ophthalmic Procedure Packs
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
Intravascular Administration Set Recall: ICU Medical Removes IV Gravity Burette Set
December 31, 2025 at 6:00 AM
Intravascular Administration Set Recall: ICU Medical Removes IV Gravity Burette Set
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