FDA Device recall Z-2290-2014
PENTAX Upper/Lower G.I. Endoscope OF-B130 and OF-B194 Gas/Water Feeding Valve
- FDA Device
- Class II
- terminated
- Published 2014-08-27
On 2014-08-27 the FDA classified a Class II recall of PENTAX Upper/Lower G.I. Endoscope OF-B130 and OF-B194 Gas/Water Feeding Valve by Pentax Medical, citing the Instructions for Use for the Pentax OF-B130 and OF-B194 Gas/Water Valve IFU if not followed carefully may cause a potential risk to health.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2290-2014 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2014-07-17 |
| Published | 2014-08-27 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Pentax Medical |
| Distribution | CA, CO, ID, IN, KS |
Product
PENTAX Upper/Lower G.I. Endoscope OF-B130 and OF-B194 Gas/Water Feeding Valve
Reason
The Instructions for Use for the Pentax OF-B130 and OF-B194 Gas/Water Valve IFU if not followed carefully may cause a potential risk to health.
Identifiers
| code_info | Model No. OF-B130 OF-B194, all units. |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2290-2014%22
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