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Recall and Alert Resources
.This page includes a list of various resources offered by the FDA regarding recalls and alerts for medical devices
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Early Alert: Infusion Set Performance Issue from BD
This communication is part of the Communications Pilot to Enhance the Medical Device Recall Program.
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FDA Authorizes Marketing of First Eyeglass Lenses to Slow Progression of Pediatric Myopia
FDA Authorizes Marketing of First Eyeglass Lenses to Slow Progression of Pediatric Myopia
http://www.fda.gov/news-events/press-announcements/fda-authorizes-marketing-first-eyeglass-lenses-slow-progression-pediatric-myopia
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FDA Removes Risk Evaluation and Mitigation Strategies (REMS) for Caprelsa (vandetanib)
FDA Removes Risk Evaluation and Mitigation Strategies (REMS) for Caprelsa (vandetanib)
http://www.fda.gov/news-events/press-announcements/fda-removes-risk-evaluation-and-mitigation-strategies-rems-caprelsa-vandetanib
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Blood and Plasma Warming Device Correction: 3M Company Issues Correction for Ranger Blood/Fluid Warming System
3M is correcting their Ranger Blood/Fluid Warming System due to incomplete temperature and flow rate specifications on the label.
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Early Alert: Automated Impella Controller Purge Retainer Fixation Issue from Abiomed
FDA is announcing an Early Alert for Abiomed’s Automated Impella Controller due to Purge Pressure Issues
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FDA Responds to Evidence of Possible Association Between Autism and Acetaminophen Use During Pregnancy
FDA Responds to Evidence of Possible Association Between Autism and Acetaminophen Use During Pregnancy
http://www.fda.gov/news-events/press-announcements/fda-responds-evidence-possible-association-between-autism-and-acetaminophen-use-during-pregnancy
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FDA Takes Action to Make a Treatment Available for Autism Symptoms
FDA Takes Action to Make a Treatment Available for Autism Symptoms
http://www.fda.gov/news-events/press-announcements/fda-takes-action-make-treatment-available-autism-symptoms
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Olympus Issues Voluntary Recall for Specific Lots of ViziShot 2 FLEX (19G) EBUS -TBNA Needles
CENTER VALLEY, Pa., (September 19, 2025) — Olympus Corporation has announced a voluntary, global medical device removal action for ViziShot 2 FLEX (19G) EBUS -TBNA needles (“ViziShot 2 FLEX”) manufactured prior to May 12, 2025, after receiving reports of device components detaching during procedures
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FDA Grants Accelerated Approval to First Treatment for Barth Syndrome
FDA Grants Accelerated Approval to First Treatment for Barth Syndrome
http://www.fda.gov/news-events/press-announcements/fda-grants-accelerated-approval-first-treatment-barth-syndrome
