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Latest posts
Last updated 12 days ago
Potential Risks with Certain Uses of Radiofrequency (RF) Microneedling – FDA Safety Communication
13 days ago
FDA is aware of serious complications reported with certain uses of radiofrequency...
Alert: Automated Impella Controller Correction due to Cybersecurity Issue from Abiomed
18 days ago
Abiomed has issued a letter to affected customers of cybersecurity vulnerabilities related...
FDA Approves Labeling Changes that Include a Boxed Warning for Immune Effector Cell-associated Enterocolitis Following Treatment with Ciltacabtagene Autoleucel (CARVYKTI, Janssen Biotech, Inc.)
18 days ago
The FDA has received reports of immune effector cell-associated enterocolitis (IEC-EC) in...
Trividia Health, Inc. Initiates Voluntary Recall of Limited Number of TRUE METRIX® Blood Glucose Meters
21 days ago
(FT. LAUDERDALE, FL) –October 7, 2025 – Trividia Health, Inc., announced today...
Update on Alert: Infusion Set Performance Issue from BD
29 days ago
This communication is part of the Communications Pilot to Enhance the Medical...
Update on Alert: Infusion Set Performance Issue from BD
29 days ago
This communication is part of the Communications Pilot to Enhance the Medical...
What is an Early Alert?
29 days ago
Early Alerts minimize time between FDA’s initial awareness of a potentially high-risk...
Recall and Alert Resources
29 days ago
.This page includes a list of various resources offered by the FDA...
Blood and Plasma Warming Device Correction: 3M Company Issues Correction for Ranger Blood/Fluid Warming System
about 1 month ago
3M is correcting their Ranger Blood/Fluid Warming System due to incomplete temperature...
Endoscopic Aspiration Needle Recall: Olympus Removes Certain ViziShot 2 FLEX (19G) Needles Due to Potentially Deformed A-traumatic Tips
about 1 month ago
Certain lots of ViziShot 2 FLEX (19G) aspiration needles may have deformed...
Endoscopic Aspiration Needle Recall: Olympus Removes Certain ViziShot 2 FLEX (19G) Needles Due to Potentially Deformed A-traumatic Tips
about 1 month ago
Certain lots of ViziShot 2 FLEX (19G) aspiration needles may have deformed...