Angiodynamics product recalled over labeling errors

Recall date

February 4, 2025

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Official notice title

Angiodynamics, Inc. recalls IsoLoc Short Profile Prostate Immobilization Treatment Balloon Device Kit; UPN/Catalog Number: ISO-60;

Recall number

Z-1391-2025

FDA classification

Class II

Brand / firm

Angiodynamics, Inc.

Sold / distributed

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

Why it was recalled

Product is mislabeled with the incorrect fill volume.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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