Class II — Potential Health Hazard

Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.

IsoLoc Short Profile Prostate Immobilization Treatment Balloon Device Kit Recalled by Angiodynamics, Inc. Due to Mislabeling

Date: February 4, 2025
Company: Angiodynamics, Inc.
Status: Ongoing
Source: FDA (Device)

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

Quantity: 1,800 units

Why Was This Recalled?

Product is mislabeled with the incorrect fill volume.

Where Was This Sold?

This product was distributed nationwide across all 50 states.

Affected (51 states)Not affected

About Angiodynamics, Inc.

Angiodynamics, Inc. has 74 total recalls tracked by RecallDetector.

Related Recalls

Data sourced from the FDA (Device). Last updated March 26, 2026. View original report