EZDilate Wire Guided Balloon 11-12-13 — Class II medical device recall Z-0941-2024
Ongoing recall by Olympus Corporation of the Americas, reported 2024-02-07, distributed nationwide. Product balloon issues: inflating, deflating and/or retrieving the devices; reports of bursting and leaking an
| Recall number | Z-0941-2024 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Olympus Corporation of the Americas, Center Valley, PA, United States |
| Recall initiated | 2023-11-10 |
| Classified | 2024-01-31 |
| Reported by FDA | 2024-02-07 |
| Distributed | Nationwide (US) |
| Quantity | 3,354 units |
| Reason classes | foreign material, packaging |
| UPC / GTIN / UDI-DI | 00821925033245 |
| Lot numbers | 369715, 370108, 370270, 370496, 377814, 378933, 379534, 386461, 386462, 388459 |
| Model numbers | BD-410X-1355 |
Product
EZDilate Wire Guided Balloon 11-12-13. Indicated for endoscopic dilation of strictures in the alimentary tract in adults and adolescents (>12 years). Model: BD-410X-1355
Reason for recall
Product balloon issues: inflating, deflating and/or retrieving the devices; reports of bursting and leaking and events involving foreign body in patient and prolonged 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-0941-2024. 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.