Angiodynamics, Inc.: Device Recall

Recall #Z-2267-2024 · 05/21/2024

Class II: Risk

Recall Details

Recall Number: Z-2267-2024
Classification: Class II
Product Type: Device
Recalling Firm: Angiodynamics, Inc.
Status: Ongoing
Date Initiated: 05/21/2024
Location: Queensbury, NY, United States
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 1,500 units (75 kits with 20 units per kit)

Reason for Recall

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).

Product Description

IsoLoc Prostate Immobilization Treatment Balloon Device Kit, Catalog/UPN: ISO-100

Distribution Pattern

US Nationwide distribution in the states of AZ, FL, IL, MO, MS, NJ, NM, NY, PA, TX, WI.

Other Recalls by Angiodynamics, Inc.

Class II: Risk 02/04/2025

Product is mislabeled with the incorrect fill volume.
Class II: Risk 11/25/2024

Potential for procedural delays or interruptions during use of the Auryon Atherectomy System due to the Auryon Atherectomy System not advancing to the Activation (Ready) mode.
Class II: Risk 06/18/2024

Mislabeled. The shelf-box labeling (unit of sale) is accurate for the packaged devices, however the inner pouch label may contain information for a different model (catheter length)
Class II: Risk 06/18/2024

Mislabeled. The shelf-box labeling (unit of sale) is accurate for the packaged devices, however the inner pouch label may contain information for a different model (catheter length)

View all recalls by Angiodynamics, Inc. →

Data from FDA openFDA enforcement reports. This site is not affiliated with or endorsed by the FDA. Recall information may be updated by the FDA at any time.