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This recall involves updating instructions for using devices and does not involve removing them from where they are used or sold. The FDA has identified this recall as the most...
On November 21, 2024, the FDA’s Center for Devices and Radiological Health (CDRH) announced a pilot to minimize the time between the FDA’s initial awareness of a potentially high-risk medical...
.This page includes a list of various resources offered by the FDA regarding recalls and alerts for medical devices Source link
This communication is part of the Communications Pilot to Enhance the Medical Device Recall Program. This recall involves removing certain devices from where they are used or sold. The FDA...
When a company learns that there is a problem with one of their medical devices, it proposes a correction or a removal depending on where the action takes place. Correction...
This recall involves removing certain devices from where they are used or sold. The FDA has identified this recall as the most serious type. This device may cause serious injury...
Summary Company Announcement Date: October 07, 2025 FDA Publish Date: October 07, 2025 Product Type: Medical Devices Reason for Announcement: Recall Reason Description Potential for defective LCD displays that can...
AUDIENCE: Patient, Health Care Professional, Pharmacy, Gastroenterology ISSUE: The FDA has received reports of immune effector cell-associated enterocolitis (IEC-EC) in patients who received treatment with CARVYKTI. Reports were received from...
This recall involves correcting devices and does not involve removing them from where they are used or sold. The FDA has identified this recall as the most serious type. This...
Date Issued: October 15, 2025 The U.S. Food and Drug Administration (FDA) is making consumers, patients, and health care providers aware that serious complications have been reported with certain uses...
