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.

2023 Safety Communications

Date Safety Communication Product Area Español
11/30/2023 Evaluating Plastic Syringes Made in China for Potential Device Failures: FDA Safety Communication Syringes

Español

11/28/2023 Carefully Monitor Philips DreamStation 2 CPAP Machines for Signs of Overheating: FDA Safety Communication CPAP Machine

Español

11/21/2023 Voluntary Recall of SoClean Equipment Intended for Use with CPAP Devices and Accessories: FDA Safety Communication Cleaner Español
11/06/2023 Recall of Certain Saline and Sterile Water Medical Products Associated with Nurse Assist: FDA Safety Communication Saline, Sterile Water Medical Products Español
09/29/2023 Update: Recommendations for Certain O&M Halyard Surgical N95 Respirators, Surgical Masks, and Pediatric Face Masks: FDA Safety Communication Surgical N95 respirators,
surgical masks,
pediatric face masks

Español

08/11/2023 Do Not Use Tests Manufactured by Universal Meditech, Inc.: FDA Safety Communication In Vitro Diagnostics Español
07/17/2023 Do Not Use RoyalVibe Health, CellQuicken, or Well-Being Reality Ultrasound Medical Devices: FDA Safety Communication Ultrasound Español
05/10/2023 UPDATE: Use of Renuvion/J-Plasma Device for Certain Aesthetic Procedures: FDA Safety Communication Plastic and Reconstructive 
Surgery
Español
05/04/2023 Do Not Use Certain SD Biosensor Pilot COVID-19 At-Home Tests: FDA Safety Communication In Vitro Diagnostics Español
03/30/2023 Evaluation of Safety Concerns with Certain Dental Devices Used on Adults: FDA Safety Communication Dental Devices Español
03/23/2023 Risks with Exactech Joint Replacement Devices with Defective Packaging – FDA Safety Communication Joint Replacement Español
03/08/2023 UPDATE: Reports of Squamous Cell Carcinoma (SCC) in the Capsule Around Breast Implants – FDA Safety Communication Mammography Español
02/07/2023 Updated: Mammography Problems at Advanced Women Imaging in Guttenberg, NJ: FDA Safety Communication Mammography Español
04/12/2023 Risk of Protection Failure with Certain O&M Halyard Surgical N95 Respirators, Surgical Masks, and Pediatric Face Masks: FDA Safety Communication (Updated 9/29/2023) Surgical N95 respirators,
surgical masks,
pediatric face masks
Español