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Safety Communications

The FDA posts Medical Device Safety Communications to describe the FDA’s analysis of a current issue and provide specific regulatory approaches and clinical recommendations for patient management. The most recent safety communications are listed by date posted.

Recent Safety Communications 

DateIssueProduct Area
11/13/2025Update: FDA Encourages the Public to Follow Established Choking Rescue Protocols: FDA Safety Communication [Español] [简体中文 (Simplified Chinese)] [Tagalog] Choking Rescue
10/15/2025Potential Risks with Certain Uses of Radiofrequency (RF) Microneedling – FDA Safety CommunicationRadiofrequency Microneedling Devices
09/16/2025Do Not Use Unauthorized Infant Devices for Monitoring Vital Signs: FDA Safety CommunicationVital Signs Monitor
09/16/2025Do Not Use Unauthorized Devices for Measuring Blood Pressure: FDA Safety CommunicationBlood Pressure Monitor
04/24/2025Update: Risk of False Positive Lead Test Results with Certain Capillary Blood Collection Tubes Used with Magellan Diagnostics LeadCare Testing Systems – FDA Safety Communication (updated on 5/27/2025)In Vitro Diagnostics
02/05/2025FDA Alerts Patients to Regularly Check Diabetes-Related Smartphone Device Alert Settings, Especially Following Phone Hardware or Software Changes [Español] [简体中文 (Simplified Chinese)] [Tagalog]Diabetes Devices
01/30/2025Update: Cybersecurity Vulnerabilities with Certain Patient Monitors from Contec and Epsimed: FDA Safety Communication (updated on 7/2/2025) [Español] [简体中文 (Simplified Chinese)] [Tagalog]Patient Monitors
12/16/2024Update: Accolade Pacemaker Devices by Boston Scientific and Potential Need for Early Device Replacement - FDA Safety Communication (updated on 9/11/2025) [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

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