FDA Alerts

Stryker Launches Voluntary Field Action for Specific Units of The LIFEPAK 15 Monitor/Defibrillator

Smiths Medical ASD, Inc. Recalls Medfusion 4000 Syringe Pumps Due to Malfunctioning Alarms and Potential Interruption of Therapy

GE Healthcare Recalls Giraffe Incubators and OmniBeds Due to Potential for Infants to Fall

Update On Device Failure Associated with Getinge's Maquet/Datascope Intra-Aortic Balloon Pumps

URGENT/11 Cybersecurity Vulnerabilities in a Widely-Used Third-Party Software Component May Introduce Risks During Use of Certain Medical Devices

Fresenius Kabi Recalls Volumat MC Agilia Infusion Pump and Vigilant Agilia Drug Library Due to a "Low Priority" "Keep Vein Open (KVO), End of Infusion" Alarm and Multiple Software Errors

Datascope/Getinge Recalls Cardiosave Hybrid, Cardiosave Rescue, CS300 and CS100/100i Intra-Aortic Balloon Pumps (IABP) Due to Potential Battery Failure

Teleflex Recalls NEONATAL ConchaSmart Breathing Circuit Due to Circuit Cracks

Hamilton Medical AG Recalls Hamilton-G5 Ventilators Due to Potential for Sporadic Error Message Resulting in the Ventilator to Cease Ventilation and Enter Ambient State

Becton Dickinson (BD) Recalls Alaris Infusion Sets for the Alaris Pump Model 8100 Due to Potential for Tube Collapse that May Cause Unintended Delivery or Faster than Expected Delivery of Medication