Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
AngioDynamics SafeSheath ULTRALITE 10F Recalled by Oscor, Inc. Due to Potential for open seal on sterile product
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Oscor, Inc. directly.
Affected Products
AngioDynamics SafeSheath ULTRALITE 10F, Model Number VI10 - Product Usage: intended for the introduction of various types of pacing leads and catheters.
Quantity: 500 devices
Why Was This Recalled?
Potential for open seal on sterile product
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About Oscor, Inc.
Oscor, Inc. has 35 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report