Z-2290-2014Class II

PENTAX Upper/Lower G.I. Endoscope OF-B130 and OF-B194 Gas/Water Feeding Valve

Name: Z-2290-2014 PENTAX Upper/Lower G.I. Endoscope OF-B130 and OF-B194 Gas/Water Feeding Valve
Creator: Pentax Medical Company
Published: 2014-07-17
License: https://open.fda.gov/license/

PENTAX of America, Inc. / initiated 2014-07-17 / Terminated / root cause: labeling and UDI

FDA source

Pentax Medical Company began a recall of PENTAX Upper/Lower G.I. Endoscope OF-B130 and OF-B194 Gas/Water Feeding Valve on 2014-07-17. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-2290-2014
Classification: Class II
Status: Terminated
Initiated: 2014-07-17
Posted: 2014-08-21
Terminated: 2015-08-20
Recalling firm: PENTAX of America, Inc.
Product: PENTAX Upper/Lower G.I. Endoscope OF-B130 and OF-B194 Gas/Water Feeding Valve
Product code: KOG
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.
Root cause tag: labeling and UDI
FDA 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 in commerce: 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.
Product codes and lots: Model No. OF-B130 OF-B194, all units.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2290-2014
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2290-2014	Class II	Terminated	Voluntary: Firm initiated	2014-08-27	2014-08-21

Product code KOG

K850020Class IIPentax Pne- Ultra-Slim Upper G.i. Fiberscope Fg-23Pentax Precision Instrument Corp. / cleared 1985-07-09

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)