FDA Device recall Z-3216-2026
Olympus EZDilate Endoscopic Balloon Dilator Wired-guided 11, 12, 13mm
- FDA Device
- Class II
- ongoing
- Published 2026-09-30
On 2026-09-30 the FDA classified a Class II recall of Olympus EZDilate Endoscopic Balloon Dilator Wired-guided 11, 12, 13mm by Olympus, citing potential for the inflation chart label affixed to the shaft of the device to be incorrect and indicate a balloon diameter of 18, 19, or 20 mm,.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-3216-2026 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2026-08-19 |
| Published | 2026-09-30 |
| Last updated | 2026-10-06 05:30 UTC |
| Company | Olympus |
| Distribution | n/a |
Product
Olympus EZDilate Endoscopic Balloon Dilator Wired-guided 11, 12, 13mm. Model Number: BD-420X-1355.
Reason
Potential for the inflation chart label affixed to the shaft of the device to be incorrect and indicate a balloon diameter of 18, 19, or 20 mm,
Identifiers
| code_info | Model Number: BD-420X-1355. UDI-DI: 00821925042261. Lot Number: 460898. |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-10-06 05:30 UTC. Current status: ongoing.
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FDA Device · Class II · 2026-10-07 · Olympus - Olympus BiCOAG Hemostasis Probe 7Fr Coaxial Connector
FDA Device · Class II · 2026-09-30 · Olympus - Olympus BiCOAG Hemostasis Probe 7Fr Fixed Pin Connector
FDA Device · Class II · 2026-09-30 · Olympus
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-3216-2026%22
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