Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Colonoscope Family # 1-Pentax Video Colonoscopes (EC Family) with One 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
Colonoscope Family # 1-Pentax Video Colonoscopes (EC Family) with One Instrument Channel and a Water Jet Channel Models: EC-2990Li, EC-3490Li, EC-3890Li, EC-3490TLi, EC-3490LK, EC-3890LK, EC3890LZi, EC34-i10L, EC38-i10L; Colonoscope Family # 2-Pentax Video Colonoscopes with Two Instrument Channels and a Water Jet Channel Model: EC-3890TLK
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