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
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
Wear Face Masks with No Metal During MRI Exams: FDA Safety Communication	12/07/20
UPDATE: The FDA Reminds Patients and Health Care Providers of the Importance of At Least Yearly, Lifelong Follow-Up with Use of Endologix AFX Endovascular AAA Graft Systems: FDA Safety Communication	12/04/20
Mammography Problems at Allison Breast Center at Monument Radiology in Richmond, Virginia: FDA Safety Communication	09/25/20
Recommendations About the Use of Dental Amalgam in Certain High-Risk Populations: FDA Safety Communication	09/24/20
FDA Reminds Users about the Importance of Following Instructions for the Cold-Therapy Mode of Water-Circulating Hot/Cold Therapy Devices: FDA Safety Communication	09/09/20
Risk of loss of coordination during water-related activities in Parkinson’s Patients with Deep Brain Stimulators: FDA Safety Communication	07/30/20
FDA Reminds Owners and Operators About Repair and Maintenance of Tanning Beds and Booths: FDA Safety Communication	07/22/20
SweynTooth Cybersecurity Vulnerabilities May Affect Certain Medical Devices: FDA Safety Communication	03/03/20
Potential Risks Associated With The Use of Ozone and Ultraviolet (UV) Light Products for Cleaning CPAP Machines and Accessories: FDA Safety Communication	02/27/20
UPDATE: Reduce the Risk of Cardiac Surgery Infection While Using the LivaNova Heater-Cooler System 3T: FDA Safety Communication	02/25/20
UPDATE: The FDA recommends performing contained morcellation in women when laparoscopic power morcellation is appropriate	02/25/20
Cybersecurity Vulnerabilities in Certain GE Healthcare Clinical Information Central Stations and Telemetry Servers: Safety Communication	01/23/20

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
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
Conduct a Trial Stimulation Period Before Implanting a Spinal Cord Stimulator (SCS) - Letter to Health Care Providers	09/03/20
Stop Using Gowns, including Surgical Gowns, from Laws of Motion PPE - Letter to Health Care Providers	08/28/20
Protective Barrier Enclosures Without Negative Pressure Used During the COVID-19 Pandemic May Increase Risk to Patients and Health Care Providers - Letter to Health Care Providers	08/20/20
Risk of Inaccurate Results with Thermo Fisher Scientific TaqPath COVID-19 Combo Kit - Letter to Clinical Laboratory Staff and Health Care Providers	08/17/20
False Positive Results with BD SARS-CoV-2 Reagents for the BD Max System - Letter to Clinical Laboratory Staff and Health Care Providers	07/06/20
Certain COVID-19 Serology/Antibody Tests Should Not Be Used - Letter to Clinical Laboratory Staff and Health Care Providers	06/19/20
Transport Media Safety Risk - Use Compatible Transport Media with SARS-CoV-2 Tests that Use Bleach - Letter to Clinical Laboratory Staff and Health Care Providers	06/04/20
Use the Correct Cycle and Compatible N95 Respirators When Decontaminating Respirators with STERRAD Sterilization Systems - Letter to Health Care Providers	05/27/20

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
Medtronic Recalls HVAD Pump Implant Kits Due to Delayed or Failed Restart After the Pump is Stopped	03/01/21
Hillrom Recalls Liko Multirall 200 Overhead Lift Due to Failure to Properly Attach Q-Link Strap Lock (Also Known as Q-Link 1 Strap Lock) to S65 Hook	02/22/21
Boston Scientific Corporation Recalls EMBLEM S-ICD (Subcutaneous Implantable Cardioverter Defibrillator) System Due to Risk of Short-Circuit	02/19/21
Boston Scientific Recalls EMBLEM S-ICD Subcutaneous Electrode (Model 3501) Due to Risk of Fractures	02/02/21
Penumbra’s Recall of the JET 7 Reperfusion Catheter Due to Distal Tip Damage	01/29/21
Cook Medical Recalls Flexor Check-Flo Introducers and Flexor Tuohy-Borst Side-Arm Introducers Due to Separation in Device	12/23/20
Baxter Healthcare Recalls Baxter SIGMA Spectrum Infusion Pumps with Master Drug Library (Versions 6 and 8) and Spectrum IQ Infusion Systems with Dose IQ Safety Software Due to Unplanned Shutdown Issues	12/01/20
Stryker Neurovascular Recalls Trevo XP ProVue Retriever Due to Core Wire That May Break or Separate During Use	11/09/20
Becton Dickinson CareFusion 303, Inc. Recalls Alaris™ System Pump Module and Pump Module Door Assembly Replacement Kits Due to the Potential for Stuck or Unresponsive Keys	10/02/20
Becton Dickinson (BD) CareFusion 303 Inc. Recalls Alaris™ Syringe and Alaris™ PCA Modules Due to Potential Incorrect Display of Syringe Types and/or Sizes	09/16/20
Becton Dickinson (BD) CareFusion 303 Recalls Alaris System Infusion Pumps Due to Damaged Inter-Unit Interface Connectors, Loose or Missing Battery Screws and A Broken Upper and Lower Hinge Posts and Membrane Frame	09/14/20
Becton Dickinson (BD) CareFusion 303, Inc. Recalls Alaris™ System PC Unit and PC Unit Front Case Keypad Replacement Kits Due to Risk of Stuck or Unresponsive Keys	09/14/20
Smiths Medical Recalls Medfusion 3500 and 4000 Syringe Pumps Due to Risk of Medication Delivery Error	08/24/20
CME America Updates Recall of BodyGuard Infusion Pump System Due to Risk of Over-, and Under-infusion	08/05/20
Verathon, Inc. Recalls GlideScope Core One TouchSmart Cable (“OneTouch cable”), Due to partial or complete loss of image during use	07/17/20

MORE MEDICAL DEVICE RECALLS