FDA Device recall Z-1391-2025
IsoLoc Short Profile Prostate Immobilization Treatment Balloon Device Kit
- FDA Device
- Class II
- ongoing
- Published 2025-03-26
On 2025-03-26 the FDA classified a Class II recall of IsoLoc Short Profile Prostate Immobilization Treatment Balloon Device Kit by Angiodynamics, citing product is mislabeled with the incorrect fill volume.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1391-2025 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2025-02-04 |
| Published | 2025-03-26 |
| Last updated | 2026-09-13 11:57 UTC |
| Company | Angiodynamics |
| Distribution | US |
Product
IsoLoc Short Profile Prostate Immobilization Treatment Balloon Device Kit; UPN/Catalog Number: ISO-60;
Reason
Product is mislabeled with the incorrect fill volume.
Identifiers
| code_info | UPN/Catalog Number: ISO-60; UDI-DI: 00851546007219; Batch/Lot No.: 5694; |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:57 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1391-2025%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.