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 [email protected].

---

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 RoyalVibe Health, CellQuicken, or Well-Being Reality Ultrasound Medical Devices: FDA Safety Communication	07/17/2023
ACTUALIZACIÓN: Uso del dispositivo Renuvion/J-Plasma para determinados procedimientos estéticos: Comunicación de seguridad de la FDA	05/30/2023
No utilice determinadas pruebas caseras de SD Biosensor Pilot COVID-19: Comunicación de seguridad de la FDA	05/17/2023
Riesgo de fallo de protección con determinados respiradores quirúrgicos N95, mascarillas quirúrgicas y mascarillas pediátricas de O&M Halyard: Comunicación de seguridad de la FDA	05/17/2023
UPDATE: Use of Renuvion/J-Plasma Device for Certain Aesthetic Procedures: FDA Safety Communication	05/10/2023
Do Not Use Certain SD Biosensor Pilot COVID-19 At-Home Tests: FDA Safety Communication	05/04/2023
Evaluación de los problemas de seguridad de determinados dispositivos dentales utilizados en adultos - Comunicación de seguridad de la FDA	04/25/2023

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
UPDATE: Paclitaxel-Coated Devices to Treat Peripheral Arterial Disease Unlikely to Increase Risk of Mortality - Letter to Health Care Providers	07/11/2023
UPDATE: NuVasive Specialized Orthopedics’ Precice Devices - Letter to Health Care Providers	06/28/2023
Oxygenator Devices Used for Extracorporeal Circulation - Letter to Health Care Providers	06/09/2023
Non-sterile, Single-use Pneumatic Tourniquet Cuffs Conservation Strategies - Letter to Health Care Providers	06/05/2023
Illumina Cybersecurity Vulnerability Affecting the Universal Copy Service Software May Present Risks for Patient Results and Customer Networks: Letter to Health Care Providers	04/27/2023

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
Medtronic Recalls Implantable Cardioverter Defibrillators (ICDs) and Cardiac Resynchronization Therapy Defibrillators (CRT-Ds) with Glassed Feedthrough for Risk of Low or No Energy Output During High Voltage Therapy	07/18/2023
Quidel Cardiovascular Inc. Recalls Quidel Triage Cardiac Panels for Risk of False Negative Troponin Results that Could Cause Delayed Diagnosis or Missed Myocardial Infarction	07/17/2023
Draeger Medical Recalls Oxylog 3000 Plus Emergency and Transport Ventilators for Risk of Unexpected Depleted Battery and Ventilator Stop	07/13/2023
NOxBOX Ltd. Recalls NOxBOXi Nitric Oxide System for Manifold Failure that May Cause Gas Leaks and Interrupt Therapy to Neonates	07/13/2023
Megadyne Recalls MEGA 2000 and MEGA Soft Reusable Patient Return Electrodes for Risk of Serious Burn Injuries to Patients	07/11/2023
Teleflex, and Arrow International, Recall ARROW Endurance Extended Dwell Peripheral Catheter System for Risk of Catheter Separation and Leakage	06/26/2023
BearCare, Inc. Recalls Rechargeable Walnut Wearable Smart Thermometers for Risks of Serious Injury, including Burns During Use	06/12/2023
Abiomed Recalls Specific Impella 5.5 with SmartAssist for Purge Fluid Leaks that Can Cause Pump Stop and Loss of Support	06/05/2023
SD BioSensor, Inc. Recalls Certain Pilot COVID-19 At-Home Tests for Potential Bacteria Contamination	05/25/2023
Draeger Medical Recalls Seattle PAP Plus and Breathing Circuit/Anesthesia Kits for Risk of Loose or Detached Components That Can Restrict Breathing Support	05/24/2023
ICU Medical Recalls Replacement Batteries for Plum 360, Plum A+, and Plum A+3 Infusion Systems Due to Diminished Battery Life that May Impact Infusion Delivery	05/22/2023
Avanos Medical Inc Recalls Certain BALLARD ACCESS Closed Suction Systems for Neonates/Pediatrics for Risk of Inadequate Ventilation, Other Injuries from Cracked Manifolds	04/21/2023

MORE MEDICAL DEVICE RECALLS