FDA Device recall Z-0935-2024
EZDilate Fixed Wire Balloon 11-12-13
- FDA Device
- Class II
- ongoing
- Published 2024-02-07
On 2024-02-07 the FDA classified a Class II recall of EZDilate Fixed Wire Balloon 11-12-13 by Olympus, citing 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.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0935-2024 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2023-11-10 |
| Published | 2024-02-07 |
| Last updated | 2026-09-13 11:57 UTC |
| Company | Olympus |
| Distribution | US |
Product
EZDilate Fixed Wire Balloon 11-12-13. Indicated for endoscopic dilation of strictures of the esophagus in adults and adolescents (>12 years). Model: BD-400P-1380
Reason
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.
Identifiers
| code_info | UDI-DI: 00821925033184 Lot Numbers: 369624, 377715 |
|---|
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-0935-2024%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.