IsoLoc Short Profile Prostate Immobilization Treatment Balloon Device… — Class II medical device recall Z-1391-2025
Ongoing recall by Angiodynamics, Inc., reported 2025-03-26, distributed nationwide. Product is mislabeled with the incorrect fill volume.
| Recall number | Z-1391-2025 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Angiodynamics, Inc., Queensbury, NY, United States |
| Recall initiated | 2025-02-04 |
| Classified | 2025-03-18 |
| Reported by FDA | 2025-03-26 |
| Distributed | Nationwide (US) |
| Quantity | 1,800 units |
| Reason classes | labeling |
| UPC / GTIN / UDI-DI | 00851546007219 |
| Lot numbers | 5694 |
| Model numbers | ISO-60 |
Product
IsoLoc Short Profile Prostate Immobilization Treatment Balloon Device Kit; UPN/Catalog Number: ISO-60;
Reason for recall
Product is mislabeled with the incorrect fill volume.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1391-2025. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.