MedWatch Safety Alerts

Catheter Recall: Medline Industries Removes Reprocessed Electrophysiology and Ultrasound Catheters

Certain reprocessed catheters may contain residual particulates that could cause infection, embolism, or thrombosis

Catheter Recall Expansion: Medline Industries Removes Reprocessed Electrophysiology and Ultrasound Catheters

Certain reprocessed catheters may contain residual particulates that could cause infection, embolism, or thrombosis

Update: FDA Encourages the Public to Follow Established Choking Rescue Protocols - FDA Safety Communication

These choking rescue protocols include abdominal thrusts (also called the “Heimlich” maneuver) for children and adults but not anti-choking devices

Stent Recall: Boston Scientific Removes Certain AXIOS Stents and Electrocautery-Enhanced Delivery Systems

Boston Scientific is removing certain stents and delivery systems due to issues with deployment and expansion

Early Alert: Heart Pump Purge Cassette Issue from Abiomed

Impella Generation 1 Purge Cassettes have an increased risk of purge leaks. Purge leaks can lead to low pump pressure and pump stops

Infusion Pump Software Correction: Fresenius Kabi Issues Correction for Ivenix Large Volume Pump Software

Fresenius Kabi is correcting Ivenix LVP software due to anomalies that could cause serious patient harm or death

Insufflation Unit Recall: Olympus Removes High Flow Insufflation Units

Olympus is removing certain High Flow Insufflation Unit models due to software issues that may lead to overpressure events

Early Alert: Trividia Health Issues Correction for TRUE METRIX Blood Glucose Monitoring Systems

Trividia recommends that device users who receive an E-5 error code and are experiencing symptoms of high glucose should seek medical care immediately

Electronic Homecare Bed Correction: Medline Updates Use Instructions for Homecare Beds

Medline updates use instructions for Electronic Homecare Beds due to risk of electrical fires and entrapment

Emergency Response Safety Kit Recall: Airlife Removes Certain Broselow Pediatric Emergency Rainbow Tapes and Broselow ALS Organizers

AirLife is removing Broselow Rainbow Tapes due to incorrectly printed medication dosing information

Trividia Health, Inc. Initiates Labeling Correction for all TRUE METRIX® Blood Glucose Monitoring Systems

FT. LAUDERDALE, FL) – February 6, 2026 – Trividia Health, Inc., announced today that it is initiating a labeling correction which requires a modification of the Owner’s Booklets/

Glucose Monitor Sensor Recall: Abbott Diabetes Care Removes Certain FreeStyle Libre 3 and FreeStyle Libre 3 Plus Sensors

Certain Abbott Diabetes Care Continuous Glucose Monitor sensors may incorrect or lower than actual glucose readings

Detachable Coil System Recall: J&J MedTech/CERENOVUS Inc. Remove CEREPAK Detachable Coil System

MedTech/CERENOVUS is removing CEREPAK Detachable Coil Systems due to a higher than expected failure to detach rate

Risk of False Positive Lead Test Results with Certain Capillary Blood Collection Tubes Used with Magellan Diagnostics LeadCare Testing Systems – FDA Safety Communication

FDA is alerting health care providers and lab staff of reports of false positives when using certain Micro Capillary Blood Collection tubes with the LeadCare Testing Systems

Early Alert: Heart Pump Issue from Abiomed

The differential pressure sensor in certain Impella devices may malfunction and cause sensor values to drift

Early Alert: Wound and Burn Dressing Issue from Integra LifeSciences

Integra is removing all MediHoney Wound and Burn products and certain lots of CVS Wound Gel that may have breached sterile barriers

Anesthesia Kit Recall: Medline Removes Anesthesia Circuits and Anesthesia Circuit Kits

Medline is removing certain anesthesia circuit kits due to cracks and leaks in the tubing

Olympus Expands Voluntary Recall for ViziShot 2 FLEX (19G) EBUS -TBNA Needles

CENTER VALLEY, Pa., (January 16, 2026) — Olympus Corporation has announced the expansion of a previous global medical device removal action for ViziShot 2 FLEX (19G) EBUS -TBNA

Anesthetic Vaporizer Recall: Draeger Removes Vapor 2000 and Vapor 3000 Vaporizers

Draeger is removing certain Vapor 2000 and Vapor 3000 Vaporizers due to impurities found within a component

Abbott Initiates Medical Device Correction for Certain FreeStyle Libre® 3 and FreeStyle Libre 3 Plus Sensors in the U.S.

ABBOTT PARK, Ill., Nov. 24, 2025 — Abbott has initiated a medical device correction for certain FreeStyle Libre 3 and FreeStyle Libre 3 Plus sensors in the United States after

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