Insulet Voluntary Correction for Omnipod 5 Pods in the U.S.
Insulet issues a voluntary correction for select Omnipod 5 Pod lots in the U.S. due to a tubing tear risk,…
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US / FDA updates on medical device regulation and quality.
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168 articles in US
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Device alert: Erbe Cryoprobe rupture risk
FDA MedWatch warns Erbe USA cryoprobes may rupture during activation, risking hearing loss and injuries. The agency and manufacturer urge…
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Wound Dressing Device Recall: Integra Removes MediHoney and CVS Products
FDA MedWatch reports a wound dressing device recall by Integra LifeSciences after sterile barrier breaches in MediHoney and CVS Wound…
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FDA Opens PreCheck Pilot to Strengthen Domestic Pharmaceutical Manufacturing
On February 12, 2026, the U S Food and Drug Administration began accepting requests to participate in the FDA PreCheck…
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FDA Grants First of Its Kind Device Approval for Locally Advanced Pancreatic Cancer
Meta description: The FDA has approved a first of its kind device for locally advanced pancreatic cancer, marking a regulatory…
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FDA Updates Labeling for Six Menopausal Hormone Therapy Products to Clarify Risk Communications
Meta description: This update enhances patient and clinician risk communication by presenting clear safety guidance across six menopausal hormone therapy…
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FDA Approves First of Its Kind Portable TTFields Device to Treat Locally Advanced Pancreatic Cancer
Publication date: February 12, 2026. The U.S. Food and Drug Administration has approved Optune Pax for adult patients with locally…
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FDA Advances Regulatory Path for No Artificial Colors Claims in Food Color Transition
Publication date context: 2026-02-12 05:04:14 UTC. The U.S. Food and Drug Administration released a new approach to support the transition…
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FDA Moves to Curb Non FDA Approved GLP1 APIs in Mass Market Compounded Drugs
Meta description: The FDA announces plans to restrict GLP1 APIs used in non FDA approved compounded drugs mass marketed by…
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FDA Initiates Comprehensive Reassessment of BHA in Foods to Clarify Safety Standards and Regulatory Pathways
Publication date context February 11 2026 at 13 44 UTC. The FDA today launched a comprehensive reassessment of butylated hydroxyanisole…
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Olympus Expands Recall of ViziShot 2 FLEX Needles Over Patient Safety Concerns
January 17, 2026 OLYMPUS CORPORATION has expanded its global medical device removal action for ViziShot 2 FLEX (19G) EBUS-TBNA needles,…
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FDA Issues Early Alert for Broselow Rainbow Tape Due to Medication Errors
The FDA has issued an early alert regarding a potentially high-risk device issue with the Broselow Rainbow Tape, a color-coded…
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