Early Alert: Flexible Cryoprobe Issue from Erbe USA
Erbe Cryoprobes may rupture during activation, leading to potential hearing loss, tinnitus, injury, or burns
FDA MedWatch
Wound and Burn Dressing Recall: Integra LifeSciences Removes Certain MediHoney and CVS Wound and Burn Products
Integra is removing certain Wound and Burn Dressing products that may have breached sterile barriers.
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.
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