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	Publish Date
Do Not Use Skippack Medical Lab SARS-CoV-2 Antigen Rapid Test: FDA Safety Communication	05/10/2022
Genetic Non-Invasive Prenatal Screening Tests May Have False Results: FDA Safety Communication	04/19/2022
Use Duodenoscopes with Innovative Designs to Enhance Safety: FDA Safety Communication	04/05/2022
Use and Store At-Home COVID-19 Tests Properly to Avoid Potential Harm: FDA Safety Communication	03/18/2022
FDA Warns Against Use of Renuvion/J-Plasma Device for Certain Aesthetic Procedures: FDA Safety Communication	03/14/2022
Do Not Use Certain ACON Flowflex COVID-19 Tests: FDA Safety Communication	03/01/2022
Do Not Use SD Biosensor STANDARD Q COVID-19 Ag Home Tests: FDA Safety Communication	03/01/2022
Do Not Use Certain Celltrion DiaTrust COVID-19 Tests: FDA Safety Communication	03/01/2022

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	Publish Date
Potential Risk of Exposure to Toxic Compounds When Using Certain Hemodialysis Machines Manufactured by Fresenius Medical Care – Letter to Health Care Providers	05/06/2022
Potential for Internal Pump Malfunction in the Medtronic HVAD System – Letter to Health Care Providers	04/28/2022
Potential Risk of Airway Obstruction When Using Certain Electromyogram Endotracheal Tubes – Letter to Health Care Providers	04/27/2022
Intended Use of Imaging Software for Intracranial Large Vessel Occlusion - Letter to Health Care Providers	04/11/2022
UPDATE: Change in Reprocessing Methods with Certain Karl Storz Urological Endoscopes – Letter to Health Care Providers	04/04/2022
Prefilled Saline Flush Syringe Conservation Strategies - Letter to Health Care Personnel	03/21/2022
FDA Advisory Panel Recommendations on Lifelong Surveillance and Long-Term Postmarket Data Collection for Patients with AAA Endovascular Aortic Repair – Letter to Health Care Providers	02/28/2022

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	Publish Date
Woodside Acquisitions Inc. Recalls Oral Rapid SARS-CoV-2 Antigen Rapid Test Kits and Joysbio SARS-CoV-2 Antigen Rapid Test Kits (Colloidal Gold) That Are Not Authorized, Cleared, or Approved by the FDA	05/16/2022
Avanos Medical Recalls Cortrak*2 Enteral Access System for Risk of Misplaced Enteral Tubes Could Cause Patient Harm	05/13/2022
SML Distribution LLC Recalls Skippack Medical Lab COVID-19 Direct Antigen Rapid Tests That Are Not Authorized, Cleared, or Approved by the FDA	05/10/2022
Mesa Biotech, Inc., Recalls Certain Accula SARS-CoV-2 Tests for Risk of False Positives Caused by Contamination	05/09/2022
Celltrion USA Recalls Certain Point of Care DiaTrust COVID-19 Ag Rapid Test Kits Which May Have Been Distributed to Unauthorized, Non-CLIA-Certified Users	04/28/2022
Medtronic Recalls Harmony Delivery Catheter, Part of Transcatheter Pulmonary Valve (TPV) System, for Risk of Capsule Break During Use	04/26/2022
Celltrion USA Recalls Certain Point of Care DiaTrust COVID-19 Ag Rapid Test Kits Labeled for Research Use Only	03/23/2022
Philips Respironics Recalls Certain V60 and V60 Plus Ventilators for Expired Adhesive that May Cause Ventilator to Stop Working With or Without an Alarm	03/21/2022
SD Biosensor Recalls STANDARD Q COVID-19 Ag Home Tests That Are Not Authorized, Cleared, or Approved by the FDA and May Give False Results	03/16/2022
Celltrion USA Recalls Certain Point of Care Celltrion DiaTrust COVID-19 Ag Rapid Tests for False Positive Test Results and Unauthorized Shelf Life	03/15/2022
LuSys Laboratories, Inc Recalls COVID-19 Antigen Tests (Nasal/Saliva) and COVID-19 IgG/IgM Antibody Tests Because They Are Not Authorized, Cleared, or Approved by the FDA	03/14/2022
Baxter recalls SIGMA Spectrum Infusion Pumps with Master Drug Library (Version 8) and Spectrum IQ Infusion Systems with Dose IQ Safety Software (Version 9) due to the risk of not alarming for repeated upstream occlusion events	03/11/2022
Medtronic Recalls TurboHawk Plus Directional Atherectomy System Due to Risk of Tip Damage During Use	03/09/2022
Arrow International, LLC (Subsidiary of Teleflex Inc.) Recalls the Arrow-Trerotola Percutaneous Thrombolytic Device Due to Risk of Tip Damage During Use	02/23/2022

MORE MEDICAL DEVICE RECALLS