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Angiodynamics, Inc. recalls IsoLoc Short Profile Prostate Immobilization Treatment Balloon Device Kit; UPN/Catalog Number: ISO-60;
Recalled March 26, 2025 · FDA recall Z-1391-2025 · Angiodynamics
Hazard
Product is mislabeled with the incorrect fill volume. · FDA Class II
Units
1,800 units
Sold at
US Nationwide distribution in the states of AZ, DC, FL, TN, TX, VA, WI.
Description
Product is mislabeled with the incorrect fill volume.
Product
IsoLoc Short Profile Prostate Immobilization Treatment Balloon Device Kit; UPN/Catalog Number: ISO-60;
Manufacturer(s)
Angiodynamics, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →