The FDA monitors reports of adverse events and other problems with medical devices and alerts health professionals and the public when needed to ensure proper use of devices and the health and safety of patients. The lists below contain our most recent information. Other safety communications can be found using the links on the left side of this page. For additional information, contact us at: 1-800-638-2041 or
DICE@fda.hhs.gov. Recent Medical Device Safety Communications
The FDA's analyses and recommendations for patients and health care providers about ongoing medical device safety issues.
MORE MEDICAL DEVICE SAFETY COMMUNICATIONS Recent Letters to Health Care Providers
Information for health care providers about the safe use of medical devices in medical facilities.
MORE LETTERS TO HEALTH CARE PROVIDERS Recent Medical Device Recalls
Medical device recalls that may potentially present significant risks to consumers or users of the product.
Allergan Recalls Natrelle Biocell Textured Breast Implants Due to Risk of BIA-ALCL Cancer 09/12/19
Edwards Lifesciences, LLC, Recalls SAPIEN 3 Ultra Delivery System Due to Burst Balloons During Surgery, Which May Result in Vascular Injury, Bleeding, or Surgical Intervention 08/22/19
Medline Industries, Inc., Recalls Centurion Medical Products' Primary Warmer Pack and Primary Set Pack Containing Becton Dickinson Alaris Pump Model 8100 Infusion Sets Due to Potential for Tube Collapse that May Cause Unintended Delivery or Faster than Expected Delivery of Medication 08/21/19
Medline Industries, Inc., Recalls Centurion Medical Products' Primary Warmer Pack Containing Vyaire Medical enFlow Fluid Warming Disposable Cartridge Due to Potential Risk of Exposure to Elevated Levels of Aluminum 08/21/19
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 08/12/19
Abbott (Formerly St. Jude Medical Inc.), Recalls Ellipse Implantable Cardioverter Defibrillators Due to Exposed Aluminum Wires That May Prevent Defibrillation Therapy 08/05/19
QIAGEN Recalls Filter Tips for use with the QIAsymphony SP/AS Instruments Due to Potential to Leak, Which May Result in Delayed or Inaccurate Results 08/02/19
Centurion Medical Products Recalls Airway Kit containing Sheridan® Endotracheal Tubes Due to Potential for the Tube Connector to Dislodge, Which May Result in Disconnection of the Patient from the Breathing Circuit 08/02/19
Datascope/Getinge Recalls Cardiosave Hybrid, Cardiosave Rescue, CS300 and CS100/100i Intra-Aortic Balloon Pumps (IABP) Due to Potential Battery Failure 07/23/19
Becton Dickinson (BD) (CareFusion 303, Inc.) Recalls Alaris Pump Module Model 8100 Bezel Assembly Which Could Result in Free Flow, Over-Infusion, Under-Infusion, or Interruption of Infusion 07/18/19
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 07/18/19
Teleflex Recalls NEONATAL ConchaSmart Breathing Circuit Due to Circuit Cracks 07/17/19
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 07/12/19
GE Healthcare, LLC Recalls Giraffe Infant Warmers and Panda i-Res Infant Warmers Due to Bedside Panels and Latch Areas Cracking or Breaking 07/12/19
MORE MEDICAL DEVICE RECALLS
Content current as of: