Extractor Pro RX Retrieval Balloon Catheter — Class II medical device recall Z-2618-2025
Ongoing recall by Boston Scientific Corporation, reported 2025-10-01, distributed nationwide. The product in incorrectly labeled. The label indicates that the skive hole should be above the balloon, while
| Recall number | Z-2618-2025 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Boston Scientific Corporation, Marlborough, MA, United States |
| Recall initiated | 2025-08-28 |
| Classified | 2025-09-23 |
| Reported by FDA | 2025-10-01 |
| Distributed | Nationwide (US) |
| Quantity | 156 units |
| Reason classes | labeling |
| UPC / GTIN / UDI-DI | 08714729790266, 08714729790280 |
| Lot numbers | 36398057, 36426495 |
| Model numbers | 08714729790266, 08714729790280, 36398057, 36426495, M00547000, M00547030 |
Product
Extractor Pro RX Retrieval Balloon Catheter; UPN (REF): (1) M00547030 (9-12mm Below), (2) M00547000 (9-12mm Above);
Reason for recall
The product in incorrectly labeled. The label indicates that the skive hole should be above the balloon, while it is actually positioned below, and vice versa.
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-2618-2025. 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.