FDA Medical Device Recalls (openFDA)
Pentax Medical Company: PENTAX Upper/Lower G.I. Endoscope OF-B130 and OF-B194 Gas/Water Feeding Valve
- Recall number
- Z-2290-2014
- Recalling firm
- Pentax Medical Company
- Product
- PENTAX Upper/Lower G.I. Endoscope OF-B130 and OF-B194 Gas/Water Feeding Valve
- Status
- Terminated
- Initiated
- 2014-07-17
- Posted
- 2014-08-21
- Terminated
- 2015-08-20
- 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.
- Root cause
- Labeling design
- Action
- 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
- Quantity
- 98 units US; 1108 units OUS
- Distribution
- Worldwide Distribution - US Distribution including the states of CA, CO, IN, KS and ID., and the countries of Asia, Canada, Europe and Japan.
- Lot, serial or model codes
- Model No. OF-B130 OF-B194, all units.
- 510(k) numbers
- ["K850020"]
- PMA numbers
- not on file
- Product code
- KOG
- Firm FEI
- 1000080301
- Firm city
- Montvale
- Firm state
- NJ
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28