U.S. flag An official website of the United States government
  1. Home
  2. Medical Devices
  3. Medical Device Safety
  1. Medical Devices

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.

FDA Safety Communication Date
SweynTooth Cybersecurity Vulnerabilities May Affect Certain Medical Devices: FDA Safety Communication 03/03/20
Potential Risks Associated With The Use of Ozone and Ultraviolet (UV) Light Products for Cleaning CPAP Machines and Accessories: FDA Safety Communication 02/27/20
UPDATE: Reduce the Risk of Cardiac Surgery Infection While Using the LivaNova Heater-Cooler System 3T: FDA Safety Communication 02/25/20
UPDATE: The FDA recommends performing contained morcellation in women when laparoscopic power morcellation is appropriate 02/25/20
Cybersecurity Vulnerabilities in Certain GE Healthcare Clinical Information Central Stations and Telemetry Servers: Safety Communication 01/23/20
UPDATE: The FDA Warns that Biotin May Interfere with Lab Tests: FDA Safety Communication 11/05/19
Update on Risk of Type III Endoleaks with Use of Endologix AFX Endovascular AAA Graft Systems: FDA Safety Communication 10/28/19
URGENT/11 Cybersecurity Vulnerabilities in a Widely-Used Third-Party Software Component May Introduce Risks During Use of Certain Medical Devices: FDA Safety Communication 10/01/19
The FDA is Recommending Transition to Duodenoscopes with Innovative Designs to Enhance Safety: FDA Safety Communication 08/29/19
The FDA Requests Allergan Voluntarily Recall Natrelle BIOCELL Textured Breast Implants and Tissue Expanders from the Market to Protect Patients: FDA Safety Communication 07/24/19
Certain Medtronic MiniMed Insulin Pumps Have Potential Cybersecurity Risks: FDA Safety Communication 07/01/19
FDA Warns People with Diabetes and Health Care Providers Against the Use of Devices for Diabetes Management Not Authorized for Sale in the United States: FDA Safety Communication 05/17/19
FDA Alerts Providers and Patients to Check for Premature Battery Depletion in Certain Medtronic Pacemakers: FDA Safety Communication 05/07/19
Mammography Problems at East Palestine Family Medical Clinic in East Palestine, Ohio: FDA Safety Communication 04/26/19

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.

Device Name Date
Risk of Misinterpreting Hydrogen Peroxide Indicator Colors for Vapor Sterilization: Letter to Health Care Providers 05/07/20
Ventilator Supply Mitigation Strategies - Letter to Health Care Providers 03/22/20
Medical Glove Conservation Strategies - Letter to Health Care Providers 03/20/20
Surgical Mask and Gown Conservation Strategies - Letter to Healthcare Providers 03/11/20
Update On Device Failure Associated with Getinge's Maquet/Datascope Intra-Aortic Balloon Pumps - Letter to Health Care Providers 11/19/19
August 7, 2019 UPDATE: Treatment of Peripheral Arterial Disease with Paclitaxel-Coated Balloons and Paclitaxel-Eluting Stents Potentially Associated with Increased Mortality 08/07/19
Programmable CSF Shunts and Magnetic Field Interference with Implanted Hearing Devices - Letter to Health Care Providers 07/16/19
UPDATE On Risk of Cross-Contamination From 24-Hour Multi-Patient Use Endoscope Connectors - Letter to Health Care Providers and Staff at Health Care Facilities Performing Gastrointestinal Endoscopy Procedures 05/23/19
December 2, 2019 UPDATE: Latest Interim post-approval study (PAS) Results Are Available for the Abiomed Impella RP System 05/21/19
UPDATE: Treatment of Peripheral Arterial Disease with Paclitaxel-Coated Balloons and Paclitaxel-Eluting Stents Potentially Associated with Increased Mortality - Letter to Health Care Providers 03/15/19
Safe Use of Surgical Staplers and Staples - Letter to Health Care Providers 03/08/19
Breast Implant Associated-Anaplastic Large Cell Lymphoma (BIA-ALCL) - Letter to Health Care Providers 02/06/19
Increased Rate of Mortality in Patients Receiving Abiomed Impella RP System - Letter to Health Care Providers 02/04/19
Treatment of Peripheral Arterial Disease with Paclitaxel-Coated Balloons and Paclitaxel-Eluting Stents Potentially Associated with Increased Mortality - Letter to Health Care Providers 01/17/19

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.

Device Name Date
Vascular Solutions, Inc. Recalls Langston Dual Lumen Catheter Due to Risk of Separation During Use 04/30/20
LeMaitre Vascular Inc. Recalls LeMaitre Over the Wire Embolectomy Catheter Due to Balloon Deflation and Separation Issue 04/02/20
CME America Recalls BodyGuard Infusion Pump System Due to Risk of Over-, and Under-infusion 03/30/20
Medtronic Recalls Pipeline Flex Embolization Devices Due to Risk of Device Fracture 03/30/20
CME America Recalls BodyGuard Microset Infusion Sets for the BodyGuard Infusion Pump System Due to Risk of Under-Infusion 03/18/20
Becton Dickinson (BD) CareFusion 303 Inc. Recalls Alaris System Infusion Pumps Due to Software and System Errors 03/06/20
King Systems Recalls King Vision Video Laryngoscope Adapter Size ½ Due to a Display of The Reversed Image 02/27/20
Tytek Medical Recalls TM-317 PneumoDart-Pneumothorax Needle Due to Fully and Partially Blocked Needles 02/25/20
Abbott Vascular Recalls NC Trek RX and NC Traveler RX Coronary Dilatation Catheters Due to Failure of Balloon (diameter 4.0mm, 4.5mm and 5.00mm) to Deflate 02/19/20
Teleflex Medical Recalls Comfort Flo Humidification Systems Due to Malfunction That May Cause Water to Enter Airway 02/19/20
ResMed Recalls Stellar 100 and 150 Non-invasive and Invasive Ventilators Due to Sound Alarm Failure 02/19/20
Medtronic Recalls MiniMed Insulin Pumps for Incorrect Insulin Dosing 02/12/20
GE Healthcare Recalls Carestation 600 Series Anesthesia Systems Due to Loss of Mechanical Ventilation 02/07/20
GE Healthcare Recalls CARESCAPE Respiratory Modules Due to Incorrect Oxygen Values 02/04/20
Distributor Teleflex Recalls the Galemed Babi.Plus Pressure Relief Manifolds Due to Dislodged Valve 01/28/20
LivaNova Recalls VNS Therapy SenTiva Generator Due to Reset Error 12/20/19
Smiths Medical ASD, Inc. Recalls Medfusion® 4000 Syringe Pumps Due to Malfunctioning Alarms and Potential Interruption of Therapy 12/19/19
GE Healthcare Recalls Giraffe Incubators and OmniBeds Due to Potential for Infants to Fall 12/17/19
Cook Medical Recalls CrossCath® Support Catheters Due to a Manufacturing Error Which May Cause the Marker Bands to Dislodge or Cause Buckling 12/17/19
Medtronic Recalls SynchroMed II Implantable Drug Infusion Pump Due to the Potential Presence of Foreign Particles Inside the Pump Motor Assembly Which May Lead to a Pump Motor StallMedtronic Recalls SynchroMed II Implantable Drug Infusion Pump Due to the Potential Presence of Foreign Particles Inside the Pump Motor Assembly Which May Lead to a Pump Motor Stall 12/16/19

MORE MEDICAL DEVICE RECALLS



Subscribe to Medical Device Safety and Recalls

Sign up to receive email updates on medical device recalls, safety communications, and other safety information.