Class II

Medical Device Recall: IsoLoc Short Profile Prostate Immobilization Treatment Balloon Device Kit; UPN/Catalog Number: ISO-60;

Angiodynamics, Inc. · February 4, 2025

Reason for Recall

Product is mislabeled with the incorrect fill volume.

Distribution

US Nationwide distribution in the states of AZ, DC, FL, TN, TX, VA, WI.

States Affected

NATIONWIDE

Quantity Affected

1,800 units

Source: FDA (openFDA Device Enforcement)

Recall number: Z-1391-2025

Status: ongoing

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