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].

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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
No use dispositivos médicos de ultrasonido RoyalVibe Health, CellQuicken o Well-Being Reality: Comunicado de seguridad de la FDA	07/28/2023
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

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
Use Alternative Testing Method for the Quidel Cardiovascular Inc. Quidel Triage Cardiac Panel - Letter to Health Care Providers	07/19/2023
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

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
Baxter Healthcare Corporation Recalls SIGMA Spectrum Infusion Pumps with Master Drug Library and Spectrum IQ Infusion Systems with Dose IQ Safety Software for Repeat Upstream Occlusion False Alarms	07/31/2023
GE HealthCare Recalls TruSignal SpO2 Sensors for Issues That May Reduce Defibrillation Energy, Expose Patients to Unintended Voltage, or Give Inaccurate Readings	07/28/2023
Abiomed Recalls All Impella Left Sided Blood Pumps for Risk of Motor Damage After Contact with Transcatheter Aortic Valve Replacement (TAVR) Stent	07/27/2023
Abbott Recalls Amplatzer Steerable Delivery Sheath for Increased Risk of Air Embolism	07/26/2023
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

MORE MEDICAL DEVICE RECALLS