The Recall Desk
Agency classClass IOur severity:SevereFDA (Devices)·Z-0084-2014·Announced 2013-11-06

Pentax Medical Recalls OF-B194 Gas/Water Feeding Valves for Endoscopes

Pentax Medical is recalling 76 OF-B194 Gas/Water Feeding Valves due to a manufacturing defect that may cause improper CO2 gas stoppage during endoscopic procedures.

The agency’s classification

FDA (Devices): Class I

Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 4/5 (Severe).

The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: The source text explicitly states the defect has the 'potential for serious hazard to and/or user,' which aligns with the rubric criterion for 'significant injury/property-damage reports' or high-risk medical device defects, warranting a score of 4.

Plain-English summary

Pentax Medical Company is recalling 76 units of the OF-B194 Gas/Water Feeding Valve, a medical device accessory used with PENTAX Upper/Lower G.I. Endoscopes. The product was manufactured in Japan and distributed nationwide, including in Arizona, California, Florida, Idaho, Indiana, Kansas, Maryland, Missouri, Mississippi, North Carolina, New York, Pennsylvania, Virginia, Wisconsin, and Wyoming.

The recall was initiated because a manufacturing defect may cause improper stoppage of CO2 gas during an endoscopic procedure. This defect presents a potential for serious hazard to the patient and/or user. The OF-B194 valve is an optional alternative to the standard Air/Water Valve, used to deliver a non-explosive gas for insufflation.

Healthcare facilities and users should stop using the affected OF-B194 Gas/Water Feeding Valves immediately. Users should contact Pentax Medical Company for instructions on how to return the product or obtain a replacement.

The recalled product

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…
Manufacturer
Pentax Medical Company
Category
Medical Device — Endoscopic Accessories
Hazard
Affected units
76

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (1)

  • Model OF-B194

Distribution

Distributed nationwide across the United States.

The notice also names 14 states specifically:

Related recalls

Same manufacturer · Pentax Medical Company

See all →

Same hazard · gas leak

See all →

Similar recalls