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  1. Safety Communications

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

 

DateSafety CommunicationProduct AreaEspañol
11/30/2023Evaluating Plastic Syringes Made in China for Potential Device Failures: FDA Safety CommunicationSyringesEspañol
11/28/2023Carefully Monitor Philips DreamStation 2 CPAP Machines for Signs of Overheating: FDA Safety CommunicationCPAP MachineEspañol
11/21/2023Voluntary Recall of SoClean Equipment Intended for Use with CPAP Devices and Accessories: FDA Safety Communication (updated 8/2024)CleanerEspañol
11/06/2023Recall of Certain Saline and Sterile Water Medical Products Associated with Nurse Assist: FDA Safety CommunicationSaline, Sterile Water Medical ProductsEspañol
09/29/2023Update: Recommendations for Certain O&M Halyard Surgical N95 Respirators, Surgical Masks, and Pediatric Face Masks: FDA Safety CommunicationSurgical N95 respirators,
surgical masks,
pediatric face masks		Español
08/17/2023Do Not Use Ultraviolet (UV) Wands That Give Off Unsafe Levels of Radiation: FDA Safety CommunicationRadiological HealthEspañol
08/11/2023Do Not Use Tests Manufactured by Universal Meditech, Inc.: FDA Safety CommunicationIn Vitro DiagnosticsEspañol
07/17/2023Do Not Use RoyalVibe Health, CellQuicken, or Well-Being Reality Ultrasound Medical Devices: FDA Safety CommunicationUltrasoundEspañol
05/10/2023UPDATE: Use of Renuvion/J-Plasma Device for Certain Aesthetic Procedures: FDA Safety CommunicationPlastic and Reconstructive 
Surgery		Español
05/04/2023Do Not Use Certain SD Biosensor Pilot COVID-19 At-Home Tests: FDA Safety CommunicationIn Vitro DiagnosticsEspañol
03/30/2023Evaluation of Safety Concerns with Certain Dental Devices Used on Adults: FDA Safety CommunicationDental DevicesEspañol
03/23/2023Risks with Exactech Joint Replacement Devices with Defective Packaging – FDA Safety CommunicationJoint Replacement Español
03/08/2023UPDATE: Reports of Squamous Cell Carcinoma (SCC) in the Capsule Around Breast Implants - FDA Safety CommunicationMammography Español
02/07/2023Updated: Mammography Problems at Advanced Women Imaging in Guttenberg, NJ: FDA Safety CommunicationMammographyEspañol
04/12/2023Risk 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

 

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