Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
AngioDynamics Safe Sheath Ultralite - Vascular Introducer/Catheter Introducer Catalogue #: Recalled by Angiodynamics Inc. (Navilyst Medical Inc.) Due to AngioDynamics, Inc. is recalling a specific batch of...
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 Angiodynamics Inc. (Navilyst Medical Inc.) directly.
Affected Products
AngioDynamics Safe Sheath Ultralite - Vascular Introducer/Catheter Introducer Catalogue #: VI10 - Product Usage: For the introduction of various types of pacing leads and catheters.
Quantity: 337 units, (14 boxes of 5, 267 units each kit)
Why Was This Recalled?
AngioDynamics, Inc. is recalling a specific batch of AngioDynamics Implantable Infusion Port kits and Valved introducers that may have potential for compromised sterility of the device. Only the specific product/lot of the kit identified below is affected by this recall action. The Product Description, Product Number, Ref./Catalog Number and Batch/Lot number is provided below. No other products are affected by this recall.
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About Angiodynamics Inc. (Navilyst Medical Inc.)
Angiodynamics Inc. (Navilyst Medical Inc.) has 78 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report