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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
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Early Alert: TactiFlex Ablation Catheter Issue from Abbott
Abbott has issued new instructions on removing TactiFlex Ablation Catheter, Sensor Enabled from its packaging due to tip detachment issues
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FDA Updates Warning About Imported Cookware That May Leach Lead: August 2025
FDA Updates Warning About Imported Cookware That May Leach Lead: August 2025. Retailers Should Not Sell and Consumers Should Not Use Certain Cookware Because of Their Potential to Leach Lead into Food When Cooking
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Early Alert: Medline Kits May Contain Recalled Medtronic Cardiac Cannulas
Medline is recalling certain Medline Kits containing recalled Medtronic DLP Left Heart Vent Catheters as the catheter may not retain its shape.
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Electrical Wheelchair Component Correction: mo-Vis BVBA Issues Correction for R-net Joysticks Due to a Firmware Error
mo-Vis BVBA is correcting R-net Joysticks due to a firmware error that may cause the wheelchair to ignore the neutral setting and move unexpectedly.
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Do Not Use Unauthorized Infant Devices for Monitoring Vital Signs: FDA Safety Communication
FDA alerts of risks with use of unauthorized infant monitoring devices, which have not been reviewed for safety and effectiveness.
