Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
IsoLoc Prostate Immobilization Treatment Balloon Device Kit Recalled by Angiodynamics, Inc. Due to Mislabeling
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. directly.
Affected Products
IsoLoc Prostate Immobilization Treatment Balloon Device Kit, Catalog/UPN: ISO-100
Quantity: 1,500 units (75 kits with 20 units per kit)
Why Was This Recalled?
A single batch of ISO-100 IsoLoc Gas-Release Endorectal Balloons is mislabeled. The affected ISO-100 balloon catheter has a nominal fill volume of 100cc/ml but the inner pouch identifies the product as an ISO-60 (fill volume of 60cc/ml).
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About Angiodynamics, Inc.
Angiodynamics, Inc. has 74 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report