Pentax of America Inc recalls Video Cystoscope models ECY-1570 and ECY-1570K
- Recall date
- July 13, 2017
- Source
- U.S. Food & Drug Administration (FDA) — enforcement report
- Recall number
- Z-0615-2018
- FDA classification
- Class II
- Brand / firm
- Pentax of America Inc
- Sold / distributed
- Distributed in 8 states: CA, IL, MD, MI, ND, NH, NY, SD, and Guam.
Why it was recalled
The video cytoscopes lack 510(k) premarket notification clearance.
Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.
What was recalled
Video Cystoscope models ECY-1570 and ECY-1570K
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