Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
PENTAX Upper/Lower G.I. Endoscope OF-B130 and OF-B194 Gas/Water Feeding Valve Recalled by Pentax Medical Company Due to The Instructions for Use for the Pentax OF-B130...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Pentax Medical Company directly.
Affected Products
PENTAX Upper/Lower G.I. Endoscope OF-B130 and OF-B194 Gas/Water Feeding Valve
Quantity: 98 units US; 1108 units OUS
Why Was This 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.
Where Was This Sold?
This product was distributed to 5 states: CA, CO, ID, IN, KS
About Pentax Medical Company
Pentax Medical Company has 26 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report