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
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
Pulse Oximeter Accuracy and Limitations: FDA Safety Communication	02/19/21
Risk of False Results with the Curative SARS-Cov-2 Test for COVID-19: FDA Safety Communication	01/04/21
Perform Only Contained Morcellation When Laparoscopic Power Morcellation Is Appropriate: FDA Safety Communication	12/29/20

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
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
Using Ventilator Splitters During the COVID-19 Pandemic - Letter to Health Care Providers	02/09/21
Genetic Variants of SARS-CoV-2 May Lead to False Negative Results with Molecular Tests for Detection of SARS-CoV-2 - Letter to Clinical Laboratory Staff and Health Care Providers	01/08/21
Penumbra’s Urgent Voluntary Recall of JET 7 Catheters with Xtra Flex Technology Due to Increased Risk of Mortality and Serious Injury – Urgent Letter to Health Care Providers	12/15/20
Potential for False Positive Results with Antigen Tests for Rapid Detection of SARS-CoV-2 - Letter to Clinical Laboratory Staff and Health Care Providers	11/03/20
Potential Risk of Infection during Cardiac Surgery When Using the CardioQuip Modular Cooler-Heater Device - Letter to Health Care Providers	09/30/20

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
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
Innova Medical Group Recalls Unauthorized SARS-CoV-2 Antigen Rapid Qualitative Test with Risk of False Test Results	06/10/21
The Biomed Guys Recalls Alaris Infusion Pump Module 8100 Bezel Due to Possible Cracked or Separated Bezel Repair Posts	06/02/21
Step-Har Medical Recalls Alaris Infusion Pump Module 8100 Bezel Due to Possible Cracked or Separated Bezel Repair Posts	05/28/21
Lepu Medical Technology Recalls SARS-CoV-2 Antigen Rapid Test Kit and Leccurate SARS-CoV-2 Antibody Rapid Test Kit (Colloidal Gold Immunochromatography) due to Risk of False Results	05/28/21
Medical Action Industries, Inc. 306 Recalls Medical Convenience Kits for Risk of Fungal (Aspergillus Penicillioides) Contamination	05/24/21
Boston Scientific Corporation Recalls VICI VENOUS STENT System and VICI RDS VENOUS STENT System for Potential of Stent Migration	05/21/21
Abbott (formally known as "St. Jude Medical") Recalls Assurity™ and Endurity™ Pacemakers for Potential Moisture Ingress Causing Electrical Short and Reduced Battery Life	05/13/21
Medtronic, Inc. Recalls Instructions for Use and Patient Manual for HeartWare HVAD System to Update Information about Carrying Case, Driveline Cover, and Controller Power-Up Issues	05/12/21
Pacific Medical Group (DBA Avante Health Solutions) Recalls Alaris Infusion Pump Module 8100 Bezel Due to Possible Cracked or Separated Bezel Repair Posts	04/30/21
Cordis Recalls Precise PRO Rx US Carotid System Due to Risk of Separation in Device During Use	04/23/21
Medtronic Perfusion Systems Recalls Bio-Console 560 Extracorporeal Blood Pumping Console for Possible Electrical Failure Causing the Pump to Stop	04/20/21

MORE MEDICAL DEVICE RECALLS