PENTAX Endoscopic Accessories — Class I medical device recall Z-0084-2014
Terminated recall by Pentax Medical Company, reported 2013-11-06, distributed nationwide. PENTAX Medical has become aware of a product issue associated with the OF-B194 Gas/Water Feeding Valve. A manu
| Recall number | Z-0084-2014 |
|---|---|
| Product type | Medical device |
| Classification | Class I |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Pentax Medical Company, Montvale, NJ, United States |
| Recall initiated | 2013-09-16 |
| Classified | 2013-10-28 |
| Reported by FDA | 2013-11-06 |
| Terminated | 2014-07-09 |
| Distributed | Nationwide (US) |
| Quantity | 76 units |
| Model numbers | OF-B194 |
Product
PENTAX Endoscopic Accessories. OF-B194. Made in Japan. PENTAX Upper/Lower G.I. Endoscopes are provided with Air/Water Valve. As an alternative, the optionally available Gas/Water Valve may be used in place of the standard Air/Water Valve to deliver a non-explosive gas for insufflation.
Reason for recall
PENTAX Medical has become aware of a product issue associated with the OF-B194 Gas/Water Feeding Valve. A manufacturing defect may cause improper stoppage of CO2 gas during an endoscopic procedure with the potential for serious hazard to and/or user.
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-0084-2014. 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.