PENTAX Upper/Lower G — Class II medical device recall Z-2290-2014
Terminated recall by Pentax Medical Company, reported 2014-08-27, distributed in CA, CO, ID, IN, KS. The Instructions for Use for the Pentax OF-B130 and OF-B194 Gas/Water Valve IFU if not followed carefully may
| Recall number | Z-2290-2014 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Pentax Medical Company, Montvale, NJ, United States |
| Recall initiated | 2014-07-17 |
| Classified | 2014-08-21 |
| Reported by FDA | 2014-08-27 |
| Terminated | 2015-08-20 |
| Distributed | CA, CO, ID, IN, KS |
| Countries outside the US | CA, JP |
| Model numbers | OF-B130, OF-B194 |
Product
PENTAX Upper/Lower G.I. Endoscope OF-B130 and OF-B194 Gas/Water Feeding Valve
Reason for recall
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2290-2014. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.