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  1. Safety Communications

2024 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.

2024 Safety Communications

DateSafety CommunicationProduct Area
12/16/2024Accolade Pacemaker Devices by Boston Scientific and Potential Need for Early Device Replacement - FDA Safety Communication [Español] [简体中文 (Simplified Chinese)] [Tagalog]Pacemakers
10/25/2024Update: Do Not Use BioZorb Marker Implantable Radiographic Marker Devices: FDA Safety Communication [Español] [简体中文 (Simplified Chinese)] [Tagalog]Breast Tissue
09/17/2024Zimmer Biomet CPT Hip System Femoral Stem and Increased Risk of Thigh Bone Fracture - FDA Safety Communication [Español] [简体中文 (Simplified Chinese)] [Tagalog]Hip System
05/13/2024Do Not Use Cue Health’s COVID-19 Tests Due to Risk of False Results: FDA Safety Communication [Español] [简体中文 (Simplified Chinese)] [Tagalog]COVID-19 Tests
04/22/2024FDA Encourages the Public to Follow Established Choking Rescue Protocols: FDA Safety Communication [Español] [简体中文 (Simplified Chinese)] [Tagalog] Choking Rescue
03/19/2024UPDATE: Evaluating Plastic Syringes Made in China for Potential Device Failures: FDA Safety Communication (updated on 8/16/2024) [Español] [简体中文 (Simplified Chinese)] [Tagalog]Syringes
02/29/2024Hintermann Series H3 Total Ankle Replacement Has a Higher-Than-Expected Risk of Device Failure: FDA Safety Communication [Español] [简体中文 (Simplified Chinese)] [Tagalog]Joint Replacement
02/27/2024BioZorb Markers and Potential Risks with Use in Breast Tissue: FDA Safety Communication [Español] [简体中文 (Simplified Chinese)] [Tagalog]Breast Tissue
02/21/2024Do Not Use Smartwatches or Smart Rings to Measure Blood Glucose Levels: FDA Safety Communication [Español] [简体中文 (Simplified Chinese)] [Tagalog]Glucose
02/02/2024Do Not Use Certain Cardinal Health Monoject Luer-Lock and Enteral Syringes - FDA Safety Communication [Español] [简体中文 (Simplified Chinese)] [Tagalog]Syringes
01/03/2024Do Not Use Synovo Total Hip Resurfacing System: FDA Safety Communication [Español] [简体中文 (Simplified Chinese)] [Tagalog] Implants
01/16/2024Risks with Exactech Equinoxe Shoulder System with Defective Packaging - FDA Safety Communication [Español​] [简体中文 (Simplified Chinese)] [Tagalog]Joint Replacement
01/18/2024Certain ResMed Ltd Masks for BiPAP, CPAP Machines Recalled Due to Safety Issue with Magnets That May Affect Certain Medical Devices: FDA Safety Communication [Español] [简体中文 (Simplified Chinese)] [Tagalog]BiPAP, CPAP Machines

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