Video Cystoscope models ECY-1570 and ECY-1570K — Class II medical device recall Z-0615-2018
Terminated recall by Pentax of America Inc, reported 2018-02-21, distributed in CA, GU, IL, MD, MI, ND, NH, NY…. The video cytoscopes lack 510(k) premarket notification clearance.
| Recall number | Z-0615-2018 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Pentax of America Inc, Montvale, NJ, United States |
| Recall initiated | 2017-07-13 |
| Classified | 2018-02-14 |
| Reported by FDA | 2018-02-21 |
| Terminated | 2019-07-22 |
| Distributed | CA, GU, IL, MD, MI, ND, NH, NY, SD |
| Quantity | 24 |
| Serial numbers | G110015, G110016, G110021, G110037, G110038, G110039, G110048, G110049, G110051, G110052, G110053, G110054, G110056, G110057, G110058, G110073, G110084, H110086, H110088, J110061, J110062, J110078, J110097, J110101 |
| Model numbers | ECY-1570, ECY-1570K |
Product
Video Cystoscope models ECY-1570 and ECY-1570K
Reason for recall
The video cytoscopes lack 510(k) premarket notification clearance.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0615-2018. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.