The FDA posts Medical Device Safety Communications to describe the FDA's current analysis of an issue and contain specific regulatory approaches and clinical recommendations for patient management.
2022 Safety Communications
Date
Safety Communication
Product Area
Español
12/22/2022
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 Respiratory
Español 12/06/2022
Update on Endologix AFX Endovascular AAA Graft Systems and Risk of Type III Endoleak: FDA Safety Communication Cardiovascular
Español 11/17/2022
UPDATE: Certain Philips Respironics Ventilators, BiPAP Machines, and CPAP Machines Recalled Due to Potential Health Risks: FDA Safety Communication Respiratory
Español 11/03/2022
Do Not Use Infant Head Shaping Pillows to Prevent or Treat Any Medical Condition: FDA Safety Communication Neurological & Physical Medicine Devices
Español 10/31/2022
Reuse Tracheostomy Tubes or Switch to Appropriate Alternatives During Shortage: FDA Safety Communication Respiratory
Español 10/25/2022
Do Not Use Certain Mighty Bliss Electric Heating Pads Due to Risk of Injury: FDA Safety Communication Physical Medicine
Español 09/15/2022
UPDATE: Pulse Oximeter Accuracy and Limitations: FDA Safety Communication Respiratory
Español 09/08/2022
Reports of Squamous Cell Carcinoma and Various Lymphomas in Capsule Around Implants: FDA Safety Communication Plastic and Reconstructive Surgery
Español 09/06/2022
Certain Philips Respironics Masks for BiPAP, CPAP Machines Recalled Due to Safety Issue with Magnets That May Affect Certain Medical Devices: FDA Safety Communication Respiratory
Español 08/29/2022
Certain Philips Respironics BiPAP Machines Recalled Due to a Plastic Issue: FDA Safety Communication Respiratory
Español 08/11/2022
At-Home COVID-19 Antigen Tests-Take Steps to Reduce Your Risk of False Negative: FDA Safety Communication In Vitro Diagnostics
Español 07/21/2022
UPDATE: Use of Renuvion/J-Plasma Device for Certain Aesthetic Procedures: FDA Safety Communication (updated 05/10/23) Plastic and Reconstructive Surgery
Español 07/20/2022
Do Not Use Ultraviolet (UV) Wands That Give Off Unsafe Levels of Radiation: FDA Safety Communication Radiological Health
Español 07/15/2022
Monkeypox Testing, Use Lesion Swab Samples to Avoid False Results: FDA Safety Communication In Vitro Diagnostics
Español 06/30/2022
UPDATE: Mammography Problems at Capitol Radiology, LLC, doing business as Laurel Radiology Services in Laurel, Maryland: FDA Safety Communication Radiological Health
Español 06/28/2022
Do Not Use Baby Neck Floats Due to the Risk of Death or Injury: FDA Safety Communication Physical Medicine
Español 06/02/2022
UPDATE: FDA Updates Recommendations for the Use of Renuvion/J-Plasma Device for Certain Aesthetic Procedures: FDA Safety Communication (updated 05/10/23, 07/21/22) Plastic and Reconstructive Surgery
Español 05/10/2022
Do Not Use Skippack Medical Lab SARS-CoV-2 Antigen Rapid Test: FDA Safety Communication In Vitro Diagnostics
Español 04/19/2022
Genetic Non-Invasive Prenatal Screening Tests May Have False Results: FDA Safety Communication In Vitro Diagnostics
Español 04/05/2022
Use Duodenoscopes with Innovative Designs to Enhance Safety: FDA Safety Communication Gastrointestinal
03/18/2022
Use and Store At-Home COVID-19 Tests Properly to Avoid Potential Harm: FDA Safety Communication In Vitro Diagnostics
03/14/2022
FDA Warns Against Use of Renuvion/J-Plasma Device for Certain Aesthetic Procedures: FDA Safety Communication (updated 05/10/23, 07/21/22, 06/02/22) Plastic and Reconstructive Surgery
03/01/2022
Do Not Use Certain ACON Flowflex COVID-19 Tests: FDA Safety Communication In Vitro Diagnostics
03/01/2022
Do Not Use SD Biosensor STANDARD Q COVID-19 Ag Home Tests: FDA Safety Communication In Vitro Diagnostics
03/01/2022
Do Not Use Certain Celltrion DiaTrust COVID-19 Tests: FDA Safety Communication In Vitro Diagnostics
02/08/2022
Potential Risk of Strangulation in Children Who Use Enteral Feeding Delivery Sets - FDA Safety Communication Drug Delivery
02/04/2022
Do Not Use E25Bio COVID-19 Tests: FDA Safety Communication In Vitro Diagnostics
01/28/2022
Stop Using Empowered Diagnostics COVID-19 Tests: FDA Safety Communication In Vitro Diagnostics
01/13/2022
Update on Risk of Type III Endoleaks with Use of Endologix AFX Endovascular AAA Graft Systems - FDA Safety Communication (updated 12/06/22) Cardiovascular
01/11/2022
Stop Using LuSys Laboratories COVID-19 Tests: FDA Safety Communication In Vitro Diagnostics
Content current as of:
01/04/2023
