CLASS II Device recall · Reported 27 Aug 2014 · FDA Enforcement Report

Pentax Upper/Lower G.I recalled by Pentax Medical

Pentax Medical is recalling Pentax Upper/Lower G.I, distributed in California, Colorado, Idaho, Indiana, Kansas. The recall was initiated on 17 Jul 2014 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesModel No. OF-B130 OF-B194, all units.

Quantity recalled98 units US; 1108 units OUS

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-2290-2014
FDA event ID: 68753
Recalling firm: Pentax Medical, Montvale, NJ
Classification: Class II
Status: Terminated
Recall initiated: 17 Jul 2014
FDA classified: 21 Aug 2014
Reported: 27 Aug 2014
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Other Reasons
Device type: Surgical Instruments

Timeline

17 Jul 2014	Recall initiated by company
21 Aug 2014	Classified by FDA	+35 days
27 Aug 2014	Published in enforcement report	+6 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

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.

Product as listed by the FDA

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

Where it was distributed

Worldwide Distribution - US Distribution including the states of CA, CO, IN, KS and ID., and the countries of Asia, Canada, Europe and Japan.

California Colorado Idaho Indiana Kansas

Questions about this recall

Is Pentax Upper/Lower G.I recalled?

Yes. Pentax Medical recalled Pentax Upper/Lower G.I on 17 Jul 2014. The recall is Class II and its status is Terminated. Recall number Z-2290-2014.

Why was it 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.

Which lots are affected?

Model No. OF-B130 OF-B194, all units.

Where was it sold?

Worldwide Distribution - US Distribution including the states of CA, CO, IN, KS and ID., and the countries of Asia, Canada, Europe and Japan.

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

More recalls from Pentax Medical

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