Autotome RX 20mm CUT WIRE Cannulating Sphincterotome — Class II medical device recall Z-2350-2024
Ongoing recall by Boston Scientific Corporation, reported 2024-07-24, distributed nationwide. Foreign material may be present on the enclosed section of the cutting wire which may lead to inability to opt
| Recall number | Z-2350-2024 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Boston Scientific Corporation, Marlborough, MA, United States |
| Recall initiated | 2024-06-12 |
| Classified | 2024-07-12 |
| Reported by FDA | 2024-07-24 |
| Distributed | Nationwide (US) |
| Reason classes | foreign material |
| UPC / GTIN / UDI-DI | 08714729444749 |
| Lot numbers | 33280747 |
| Expiration dates | 2027-01-23 |
Product
Autotome RX 20mm CUT WIRE Cannulating Sphincterotome, Material Number (UPN) M00545170. The device is used in selective cannulation of the bile duct.
Reason for recall
Foreign material may be present on the enclosed section of the cutting wire which may lead to inability to optimally bow the sphincterotome. This issue may lead to prolongation of procedure.
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-2350-2024. 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.