Angiodynamics, Inc.: Medical Device Recall in 2024 - (Recall #: Z-2267-2024)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2024.

Data Source: FDA.

Product Description:

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

Product Classification:

Class II

Date Initiated: May 21, 2024

Date Posted: July 10, 2024

Recall Number: Z-2267-2024

Event ID: 94773

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).

Status: Ongoing

Product Quantity: 1,500 units (75 kits with 20 units per kit)

Code Information:

UPN/Catalog: ISO-100; UDI/DI: 10851546007100 (Box) and 00851546007103 (Pouch); Lot number: 5402.

Distribution Pattern:

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

Voluntary or Mandated:

Voluntary: Firm initiated