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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.

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
ACTUALIZACIÓN: Uso del dispositivo Renuvion/J-Plasma para determinados procedimientos estéticos: Comunicación de seguridad de la FDA
No utilice determinadas pruebas caseras de SD Biosensor Pilot COVID-19: Comunicación de seguridad de la FDA
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
UPDATE: Use of Renuvion/J-Plasma Device for Certain Aesthetic Procedures: FDA Safety Communication
Do Not Use Certain SD Biosensor Pilot COVID-19 At-Home Tests: FDA Safety Communication
Evaluación de los problemas de seguridad de determinados dispositivos dentales utilizados en adultos - Comunicación de seguridad de la FDA
Risk of Protection Failure with Certain O&M Halyard Surgical N95 Respirators, Surgical Masks, and Pediatric Face Masks: FDA Safety Communication
Riesgos de las prótesis articulares de Exactech con embalaje defectuoso: comunicación de seguridad de la FDA
Actualización sobre reportes de carcinoma de células escamosas en la cápsula alrededor de los implantes de seno: Comunicado de seguridad de la FDA
Evaluation of Safety Concerns with Certain Dental Devices Used on Adults – FDA Safety Communication
Risks with Exactech Joint Replacement Devices with Defective Packaging - FDA Safety Communication
UPDATE: Reports of Squamous Cell Carcinoma (SCC) in the Capsule Around Breast Implants - FDA Safety Communication

Recent Medical Device Recalls

Medical device recalls that may potentially present significant risks to consumers or users of the product.

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