The Recall Desk
ModerateFDA (Devices)·Z-1391-2025·Announced 2025-03-26

IsoLoc Prostate Treatment Balloon Devices Recalled for Incorrect Fill Volume Labeling

Angiodynamics is recalling 1,800 units of IsoLoc prostate treatment balloons due to incorrect fill volume labeling. The affected devices were distributed nationwide.

What this means for you

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: FDA Class II recall involving labeling error with no reported hospitalizations or adverse events. Meets criteria for Moderate severity: minor labeling errors without reported injury.

Plain-English summary

Angiodynamics, Inc. is recalling the IsoLoc Short Profile Prostate Immobilization Treatment Balloon Device Kit (Catalog Number ISO-60), affecting 1,800 units distributed nationwide in Arizona, District of Columbia, Florida, Tennessee, Texas, Virginia, and Wisconsin.

The affected devices are mislabeled with an incorrect fill volume specification. These devices are identified by Lot Number 5694 and UDI-DI 00851546007219.

Healthcare facilities and clinicians who have received affected devices should immediately contact Angiodynamics, Inc. for further instructions and guidance on managing affected inventory.

The FDA has classified this as a Class II recall.

The recalled product

Product
IsoLoc Short Profile Prostate Immobilization Treatment Balloon Device Kit; UPN/Catalog Number: ISO-60;
Manufacturer
Angiodynamics, Inc.
Category
Medical Device — Urology
Hazard
  • mis-labeling

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (3)

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

Distribution

Distributed nationwide across the United States.

Related recalls

Same category