FDA Device recall Z-0905-2016
Olympus, Model No. TJF-160F, flexible scope, large diameter, video duodenoscope
- FDA Device
- Class II
- terminated
- Published 2016-03-02
On 2016-03-02 the FDA classified a Class II recall of Olympus, Model No. TJF-160F, flexible scope, large diameter, video duodenoscope by Integrated Medical Systems, citing if excessive pressure is applied to the distal end of the endoscope, the internal coil pipe assembly at the distal end of the endoscope can become detached and angulation may not….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0905-2016 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2016-01-20 |
| Published | 2016-03-02 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Integrated Medical Systems |
| Distribution | US |
Product
Olympus, Model No. TJF-160F, flexible scope, large diameter, video duodenoscope
Reason
If excessive pressure is applied to the distal end of the endoscope, the internal coil pipe assembly at the distal end of the endoscope can become detached and angulation may not operate as intended.
Identifiers
| code_info | Serial Numbers: 2201503,2000062,2000105,2100621,2301997,2100999,2201555,2302025,2000061, 2201491,2000039,2100930,2402518,2302084,2100852,2101121 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0905-2016%22
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