Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Gastroscope Family # 1-Gastroscopes without a Water Jet Channel Models: EG-2790i Recalled by Pentax of America Inc Due to Updated Reprocessing Instruction For Use (rIFU): Impacted PENTAX...
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 of America Inc directly.
Affected Products
Gastroscope Family # 1-Gastroscopes without a Water Jet Channel Models: EG-2790i, EG-1690K, EG-2490K, EG-2790K, EG27-i10; Gastroscope Family # 2- Gastroscopes with a Water Jet Channel Models: EG-2990i, EG-2990K, EG-3490K, EG29-i10; Gastroscope Family # 3-Gastroscopes with Two Instrument Channels and a Water Jet Channel Models: EG-3890TK
Quantity: 28849 units Total
Why Was This Recalled?
Updated Reprocessing Instruction For Use (rIFU): Impacted PENTAX Medical Video Upper GI Scopes (EG) and Video Colonoscopes (EC) families
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About Pentax of America Inc
Pentax of America Inc has 28 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report