FDA Device recall Z-0084-2014
PENTAX Endoscopic Accessories
- FDA Device
- Class I
- terminated
- Published 2013-11-06
On 2013-11-06 the FDA classified a Class I recall of PENTAX Endoscopic Accessories by Pentax Medical, citing 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 end….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0084-2014 |
| Classification | Class I |
| Status | terminated |
| Initiated | 2013-09-16 |
| Published | 2013-11-06 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Pentax Medical |
| Distribution | US |
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
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.
Identifiers
| code_info | Model OF-B194 |
|---|
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-0084-2014%22
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