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
Update: Certain Philips Respironics Ventilators, BiPAP, and CPAP Machines Recalled Due to Potential Health Risks: FDA Safety Communication
11/12/21
Potential for Medication Overdose with ENFit Low Dose Tip Syringe: FDA Safety Communication
10/12/21
Do Not Use Needle-Free Devices for Injection of Dermal Fillers – FDA Safety Communication
10/08/21
Potential for False Positive Results with Certain Lots of Ellume COVID-19 Home Tests Due to a Manufacturing Issue: FDA Safety Communication
10/05/21
Risk of Exposure to Unsafe Levels of Radiation with Safe-T-Lite UV WAND: FDA Safety Communication
09/29/21
Mammography Problems at Madison Avenue Radiology Center 190th Broadway in New York, New York: FDA Safety Communication
08/26/21
UPDATE: Caution with Robotically-Assisted Surgical Devices in Mastectomy: FDA Safety Communication
08/20/21
Potential Concerns with NuVasive MAGEC System Implants - FDA Safety Communication
07/15/21
Certain Philips Respironics Ventilators, BiPAP, and CPAP Machines Recalled Due to Potential Health Risks: FDA Safety Communication
06/30/21
Flexible Bronchoscopes and Updated Recommendations for Reprocessing: FDA Safety Communication
06/25/21
Stop Using Innova Medical Group SARS-CoV-2 Antigen Rapid Qualitative Test: FDA Safety Communication
06/10/21
Stop Using Lepu Medical Technology SARS-CoV-2 Antigen and Leccurate Antibody Tests: FDA Safety Communication
05/28/21
Mammography Problems at Advanced Women Imaging in Guttenberg, NJ: FDA Safety Communication
05/21/21
Mammography Problems at Capitol Radiology, LLC, doing business as Laurel Radiology Services in Laurel, Maryland: FDA Safety Communication
05/20/21
Antibody Testing Is Not Currently Recommended to Assess Immunity After COVID-19 Vaccination: FDA Safety Communication
05/19/21
Acellular Dermal Matrix (ADM) Products Used in Implant-Based Breast Reconstruction Differ in Complication Rates: FDA Safety Communication
03/31/21
Mammography Problems at Tennessee Women’s Care P.C. in Nashville, TN: FDA Safety Communication
03/30/21
Risk of Device Component Breaking in Patients with Stryker’s STAR Ankle: FDA Safety Communication
03/15/21
Improper Use of Thermal Imaging Devices: FDA Safety Communication
03/04/21
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
Getinge/Datascope/Maquet Recalls Cardiosave Hybrid and Cardiosave Rescue Intra-Aortic Balloon Pump (IABP) Due to Reports of Fluid Leaks
12/16/21
Arrow International Inc Recalls Arrow-Trerotola Over-The-Wire PTD Kit Percutaneous Thrombolytic Device: 7Fr, Due to Risk of Separation
12/03/21
Ellume Recalls COVID-19 Home Test for Potential False Positive SARS-CoV-2 Test Results
11/10/21
Aligned Medical Solutions Doing Business as Windstone Medical Packaging, Inc. Recalls Custom Convenience Kits Due to Cardinal Health Monoject Flush Prefilled Syringe (0.9% Sodium Chloride) Plunger Defect
11/09/21
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
MORE MEDICAL DEVICE RECALLS
Content current as of:
12/22/2021