Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Video Cystoscope models ECY-1570 and ECY-1570K Recalled by Pentax of America Inc Due to The video cytoscopes lack 510(k) premarket notification clearance.
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
Video Cystoscope models ECY-1570 and ECY-1570K
Quantity: 24
Why Was This Recalled?
The video cytoscopes lack 510(k) premarket notification clearance.
Where Was This Sold?
This product was distributed to 8 states: CA, IL, MD, MI, NH, NY, ND, SD
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