Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Pentax Video Colonoscope Model: EC38-i10L Recalled by Pentax of America Inc Due to Distributed in the USA without an approved 510K
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
Pentax Video Colonoscope Model: EC38-i10L
Quantity: 1 unit
Why Was This Recalled?
Distributed in the USA without an approved 510K
Where Was This Sold?
This product was distributed to 2 states: MA, NC
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