Medical Device Safety

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.

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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.

Device Name	Date
UPDATE: Potential Biocompatibility Concerns with NuVasive Specialized Orthopedics’ Precice Devices - Letter to Health Care Providers	12/01/21
Leadless Pacing Systems: Risk of Major Complications Related to Cardiac Perforation During Implantation - Letter to Health Care Providers	11/17/21
UPDATE: Potential Risk of Infection When Using Heater-Cooler Devices – Letter to Health Care Providers	10/13/21
UPDATE: Safe Use of Surgical Staplers and Staples - Letter to Health Care Providers	10/07/21
Left Atrial Appendage Occlusion (LAAO) Devices Potentially Associated with Procedural Outcome Differences Between Women and Men – Letter to Health Care Providers	09/27/21
Potential for False Positive Results with Abbott Molecular Inc. Alinity m SARS-CoV-2 AMP and Alinity m Resp-4-Plex AMP Kits - Letter to Clinical Laboratory Staff and Health Care Providers	09/17/21
Potential Risk of Aluminum Leaching with Use of Certain Fluid Warmer Devices - Letter to Health Care Providers	09/15/21
Stop Using Certain N95 Respirators Manufactured by Shanghai Dasheng - Letter to Health Care Providers	08/25/21
Stop Using All Eco-Med Ultrasound Gels and Lotions Due to Risk of Bacterial Contamination – Letter to Health Care Providers	08/18/21
Potential Biocompatibility Concerns with NuVasive Specialized Orthopedics’ Precice Devices – Letter to Health Care Providers	07/08/21
Update: FDA No Longer Authorizes Use of Non-NIOSH-Approved or Decontaminated Disposable Respirators - Letter to Health Care Personnel and Facilities	06/30/21
Sodium Citrate Blood Specimen Collection Tube Conservation Strategies - Letter to Health Care and Laboratory Personnel	06/10/21
Stop New Implants of the Medtronic HVAD System - Letter to Health Care Providers	06/03/21
Update: FDA Recommends Transition from Use of Non-NIOSH-Approved and Decontaminated Disposable Respirators - Letter to Health Care Personnel and Facilities	05/27/21
Stop Using Certain Syringes and Needles with Needle Safety Devices Manufactured by HAIOU – Letter to Health Care Providers	05/20/21
FDA Recommends Transition from Use of Decontaminated Disposable Respirators - Letter to Health Care Personnel and Facilities	04/09/21
Infections Associated with Reprocessed Urological Endoscopes - Letter to Health Care Providers	04/01/21
Potential for False Results with Roche Molecular Systems, Inc. cobas SARS-CoV-2 & Influenza Test for use on cobas Liat System-Letter to Clinical Laboratory Staff, Point-of-Care Facility Staff, and Health Care Providers	03/12/21

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
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