PENTAX Upper/Lower G.I. Endoscope OF-B130 and OF-B194… recallZ-2290-2014 · Pentax Medical Company · initiated Jul 17, 2014
Class II Terminated All recalls posted in August 2014
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Pentax Medical Company or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
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.
FDA root cause category: Labeling design
What the company is doing
Pentax Medical sent an Urgent Medical Device Recall Field Safety Corrective Action letter dated July 16, 2014, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. If the Instruction for Use are not followed carefully by the user there is a potential risk to health for the patient, such as a perforation. Customers are asked to complete the attached response form and fax to (201) 799-4063. Customers should see the attached revised Instructions for Use Z632 R09. If you have any questions regarding this action, please feel free to contact your Sales Representative at : 800-431-5880 ext 2064
Recall details
- Recall number
- Z-2290-2014
- Recall class
- Class II
- Status
- Terminated
- Initiated by the company
- Jul 17, 2014
- Posted by the FDA
- Aug 21, 2014
- Recalling firm
- Pentax Medical Company
- Quantity
- 98 units US; 1108 units OUS
- Product code
- KOG
- FDA submissions
- K850020
- Distribution
- Worldwide Distribution - US Distribution including the states of CA, CO, IN, KS and ID., and the countries of Asia, Canada, Europe and Japan.
Product description
PENTAX Upper/Lower G.I. Endoscope OF-B130 and OF-B194 Gas/Water Feeding Valve
Code information (models, lots, serial numbers)
Model No. OF-B130 OF-B194, all units.
Other devices under the same FDA submission
2 devices cleared under K850020 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.
- PENTAX FG-24VHoya Corporation · Gastroscope and accessories, flexible/rigid5 reports
- PENTAX OF-B194Hoya Corporation · Gastroscope and accessories, flexible/rigid1 report
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 18, 2026. Text above is shown as published by the FDA.
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