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.
FDA MedWatch
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
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
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/System Instructions for Use for all TRUE METRIX, TRUE METRIX AIR, TRUE METRIX GO, and TRUE METRIX PRO Blood Glucose Monit
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
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
Glucose Monitor Sensor Recall: Abott 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
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: Insufflation Unit Issue from Olympus
Olympus is removing certain High Flow Insufflation Unit models due to software issues that may lead to overpressure events.
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
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 needles (“ViziShot 2 FLEX”) after receiving and investigating complaints of device components ejecting or detaching during
Early Alert: Stent and Electrocautery-Enhanced Delivery System Issue from Boston Scientific
Boston Scientific is removing certain stents and delivery systems due to issues with deployment and expansion.
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.
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.
Early Alert: Broselow Rainbow Tape Issue from AirLife
AirLife is removing Broselow Rainbow Tapes due to incorrectly printed medication dosing information.