2023 Safety Communications

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 (updated 8/2024)	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