Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
EG-3630U Ultrasound Video Gastroscope EG-3830UT Ultrasound Video Gastroscope EG-3870UTK Ultrasound Recalled by Pentax Medical Company Due to Aspiration needles used in combination with Ultrasound Gastroscopes...
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
EG-3630U Ultrasound Video Gastroscope EG-3830UT Ultrasound Video Gastroscope EG-3870UTK Ultrasound Video Gastroscope FG-36UX Ultrasound Fiber Gastroscope Used to provide optical and sonographic visualization of and therapeutic access to the Upper Gastrointestinal Tract.
Quantity: 531 units
Why Was This Recalled?
Aspiration needles used in combination with Ultrasound Gastroscopes can derail from the accessory elevator at the distal end of the endoscope. This may result in patient injury if the Instruction for Use is not followed carefully by the user.
Where Was This Sold?
This product was distributed nationwide across all 50 states.
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