Angiodynamics, Inc.: Medical Device Recall in 2025 - (Recall #: Z-1391-2025)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2025.

Data Source: FDA.

Product Description:

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

Product Classification:

Class II

Date Initiated: February 4, 2025

Date Posted: March 26, 2025

Recall Number: Z-1391-2025

Event ID: 96192

Reason for Recall:

Product is mislabeled with the incorrect fill volume.

Status: Ongoing

Product Quantity: 1,800 units

Code Information:

UPN/Catalog Number: ISO-60; UDI-DI: 00851546007219; Batch/Lot No.: 5694;

Distribution Pattern:

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

Voluntary or Mandated:

Voluntary: Firm initiated