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
Actualizado: Problemas de mamografía en Advanced Women Imaging en Guttenberg, NJ	02/14/2023
2023 Safety Communications	02/07/2023
Se retiran del mercado ciertos ventiladores Philips Respironics Trilogy 100/200 reacondicionados debido a posibles fallos de adhesión de la espuma de silicona y a residuos de espuma PE-PURl: Comunicado de seguridad de la FDA	01/04/2023
ACTUALIZACIÓN: La FDA actualiza las recomendaciones para el uso del dispositivo Renuvion/J-Plasma en determinados procedimientos estéticos: Comunicado de seguridad de la FDA	12/28/2022
No utilice la prueba rápida de antígeno SARS-CoV-2 de Skippack Medical Lab: Comunicado de seguridad de la FDA	12/28/2022
Certain Reworked Philips Respironics Trilogy 100/200 Ventilators Recalled Due to Potential for Silicone Foam Adhesion Failure and Residual PE‐PUR Foam Debris: FDA Safety Communication	12/22/2022
ACTUALIZACIÓN: Se retiran del mercado ciertos ventiladores, máquinas BiPAP y máquinas CPAP de Philips Respironics debido a posibles riesgos para la salud: Comunicado de seguridad de la FDA	12/15/2022
Actualización de los sistemas endovasculares de injerto de AAA Endologix AFX y el riesgo de endofuga de tipo III: Comunicado de seguridad de la FDA	12/14/2022
Update on Endologix AFX Endovascular AAA Graft Systems and Risk of Type III Endoleak: FDA Safety Communication	12/06/2022

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
Abbott Trifecta Valves: Potential Risk of Early Structural Valve Deterioration- Letter to Health Care Providers	02/27/2023
2023 Letters to Health Care Providers	02/23/2023
Evaluation of Airborne Chemicals from Neonatal Incubators – Letter to Health Care Providers	02/23/2023
UPDATE: Impella RP System Post-Approval Study Results and Updated Labeling - Letter to Health Care Providers	12/05/2022
Getinge Maquet/Datascope Intra-Aortic Balloon Pump (IABP) Shortage - Letter to Health Care Providers	12/02/2022

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
Philips Respironics Recalls Certain Reworked Philips Respironics Trilogy 100/200 and Garbin Ventilators Due to Potential for Silicone Foam Adhesion Failure and Residual PE‐PUR Foam Debris	02/16/2023
GE HealthCare Recalls Nuclear Medicine 600/800 Series Systems for Risk of Detector Fall That May Injure Patients	02/15/2023
Universal Meditech Inc. Recalls Skippack Medical Lab COVID-19 Direct Antigen Rapid Tests That Are Not Authorized, Cleared, or Approved by the FDA	02/08/2023
Smiths Medical Recalls Certain CADD System Administration Sets and Cassette Reservoirs for Issues Causing Delay, Interruption, or Under-Delivery of Therapy	02/02/2023
Medtronic Recalls Mahurkar Acute Dual Lumen High Flow Hemodialysis Catheters for Potential Catheter Hub Defect	01/30/2023
LivaNova (TandemLife) Adds to Recall for LifeSPARC System that May Experience Unintentional Extended Pump Stops Due to Controller Critical Failure	01/27/2023
Emergent Recalls Certain RSDL (Reactive Skin Decontamination Lotion) Kits Due to Leak Potential	01/26/2023
2023 Medical Device Recalls	01/25/2023
Datascope/Getinge Recalls Cardiosave Hybrid and Rescue Intra-Aortic Balloon Pumps (IABP) for Risk That Blood May Enter Pump Through Damaged Balloon Catheter, Causing Patient Harm	01/25/2023
Whele LLC Recalls Mighty Bliss Electric Heating Pads Due to Injury Risks Including Electric Shocks, Skin Burns, and Rashes	12/20/2022
Arrow International, LLC, subsidiary of Teleflex, Inc Recalls Arrow AutoCAT 2, AC3 Intra-Aortic Balloon Pumps for Unexpectedly Short Battery Run Times	12/20/2022
Teleflex and Arrow International, LLC Recall Arrow MAC Two-Lumen Central Venous Access and Pressure Injectable Arrowg+ard Blue Plus Three-Lumen Central Venous Catheter (CVC) Kits	12/16/2022
Remel, Inc Recalls Thermo Scientific Gram Negative IVD AST Sensititre Plate for risk of potential false susceptible results	12/09/2022
Dewei Medical Equipment Co. Recalls DNA/RNA Preservation Kits That Are Not Authorized, Cleared, or Approved by the FDA	12/08/2022

MORE MEDICAL DEVICE RECALLS