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.
Device Name
Date
Datascope/Getinge/Maquet Recalls Cardiosave Hybrid/Rescue Intra-Aortic Balloon Pump Battery Packs Due to Risk of Battery Failure
10/29/21
Zimmer Biomet Recalls ROSA One 3.1 Brain Application Due to Error in Software
10/29/21
Abbott Molecular, Inc. Recalls Alinity m SARS-CoV-2 AMP Kit and Alinity m Resp-4-Plex AMP Kit for Potential False Positive SARS-CoV-2 Test Results
10/14/21
DeRoyal Industries, Inc. Recalls Procedure Packs Containing Smiths Medical NORMOFLO Irrigation Warming Set Due to the Possibility of Harmful Levels of Aluminum Leaching into the Fluid Path of the Warmers
10/06/21
Imperative Care Inc. Recalls ZOOM 71 Reperfusion Catheter Due to Risk of Breaks During Use
10/06/21
Medtronic Recalls Remote Controllers Used with Paradigm and 508 MiniMed Insulin Pumps for Potential Cybersecurity Risks
10/05/21
Armstrong Medical Limited Recalls AMSORB PLUS PREFILLED G-CAN 1.0L Due to Reduced Gas Flow to Patients During Anesthesia
09/23/21
Cordis Recalls Super Torque MB Angiographic Catheter with Radiopaque Marker Bands Due to Potential for Marker Bands to Move or Dislodge
09/22/21
Medtronic Recalls Pipeline Flex Embolization Devices for Risk of Delivery System Fractures During Placement, Retrieval, or Movement of Device
09/20/21
Smiths Medical Recalls NORMOFLO Irrigation Fluid Warmers and Warming Sets Due to the Possibility of Harmful Levels of Aluminum Leaching into the Fluid Path of the Warmers
09/15/21
All Ultrasound Gels and Lotions Manufactured by Eco-Med Pharmaceutical, Inc. Recalled Due to Risk of Bacteria Contamination
09/10/21
Bio-Medical Equipment Service Co. Recalls Alaris Infusion Pump Module 8100 Bezel Due to Possible Cracked or Separated Bezel Repair Posts
08/24/21
Cardinal Health Recalls Monoject Saline Flush Prefilled Syringes for Risk of Air Re-entering Syringe Leading to Air Embolism
08/23/21
Cardinal Health Recalls Argyle UVC Insertion Tray Due to Missing Instructions for Use for the Safety Scalpel N11
08/20/21
Medtronic Stops Distribution and Sale of HeartWare HVAD System Due to Risk of Neurological Adverse Events, Mortality, and Potential Failure to Restart
08/12/21
Baxter Healthcare Recalls Dose IQ Software Version 9.0.x, Used with Spectrum IQ Infusion Pumps, for Software Defect That May Improperly Configure Drug and Fluid Delivery
08/12/21
Boston Scientific Recalls INGENIO Family of Pacemakers and CRT-Ps Due to Risk of Transition to Safety Mode
08/06/21
Eight Medical International Recalls Recirculator 8.0 Disposable Lavage Kits due to Potential Exposure to High Levels of Aluminum
08/05/21
Philips Respironics Recalls V60 and V60 Plus Ventilators Equipped with High Flow Therapy Software Versions 3.00 and 3.10 Due to Risk of Receiving Reduced Oxygen
08/03/21
Philips Respironics Recalls Certain Continuous and Non-Continuous Ventilators, including CPAP and BiPAP, Due to Risk of Exposure to Debris and Chemicals
07/22/21
Philips Respironics Recalls Certain Ventilators and BiPAP Machines Due to Potential Health Risks from PE-PUR Sound Abatement Foam
07/22/21
Vero Biotech Recalls GENOSYL DS; Nitric Oxide Delivery System Due to Software Error
07/21/21
Quidel Recalls Lyra SARS-CoV-2 Assay (M120) Due to Risk of False Negative Results
07/07/21
Magellan Diagnostics Recalls LeadCare II, LeadCare Plus, and LeadCare Ultra Blood Lead Tests Due to Risk of Falsely Low Results
07/01/21
Infusion Pump Repair Recalls Alaris Infusion Pump Module 8100 Bezel Due to Possible Cracked or Separated Bezel Repair Posts
06/15/21
MORE MEDICAL DEVICE RECALLS
Content current as of:
10/29/2021