Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
MEDRAD Hand Controller Sheath Recalled by Medrad Inc Due to The seal between the white polyethylene and the...
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 Medrad Inc directly.
Affected Products
MEDRAD Hand Controller Sheath, Catalog number AVA 500 HCS/3010903, for cardiac catheterization procedures. The Sterile Sheath is specifically intended for use in the x-ray angiography environment to cover the Medrad Avanta Sterile Hand Controller to prevent cross contamination between patients.
Quantity: 832,175
Why Was This Recalled?
The seal between the white polyethylene and the clear plastic may be missing on the Hand Controller Sheath package, resulting in a potential breach of the sterility of this accessory.
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About Medrad Inc
Medrad Inc has 13 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report