FDA Device recall Z-1682-2021
Pentax Medical Video Duodenoscope - Product Usage: intended to be used with endoscopic devices and other ancillary equipment to provide opt…
- FDA Device
- Class II
- terminated
- Published 2021-06-02
On 2021-06-02 the FDA classified a Class II recall of Pentax Medical Video Duodenoscope - Product Usage: intended to be used with endoscopic devices and other ancillary equipment to provide opt… by Pentax, citing IFU updated: The warning section of the IFU for both the OE-A63 distal end cap and ED34-i10T2 duodenoscope has been updated to notify users of the associated risks with the distal….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1682-2021 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2021-04-21 |
| Published | 2021-06-02 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Pentax |
| Distribution | US |
Product
Pentax Medical Video Duodenoscope - Product Usage: intended to be used with endoscopic devices and other ancillary equipment to provide optical visualization of (via a video monitor), and therapeutic access to, Biliary Tract via the Upper Gastrointestinal Tract, Model Number: ED34-i10T2.
Reason
IFU updated: The warning section of the IFU for both the OE-A63 distal end cap and ED34-i10T2 duodenoscope has been updated to notify users of the associated risks with the distal end cap (OE-A63) unexpectedly becoming detached during a procedure and updated to notify users of what immediate actions should be taken in case the event occurs. This can result in unforseen events such as mucosal injury, lacerations, or bleeding of the patient. Detachment of the distal end cap (OE-A63) into the oral cavity of the patient may also result in aspiration
Identifiers
| code_info | All units |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1682-2021%22
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