FDA Device recall Z-0615-2018
Video Cystoscope models ECY-1570 and ECY-1570K
- FDA Device
- Class II
- terminated
- Published 2018-02-21
On 2018-02-21 the FDA classified a Class II recall of Video Cystoscope models ECY-1570 and ECY-1570K by Pentax, citing the video cytoscopes lack 510(k) premarket notification clearance.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0615-2018 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2017-07-13 |
| Published | 2018-02-21 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Pentax |
| Distribution | CA, IL, MD, MI, ND, NH, NY, SD |
Product
Video Cystoscope models ECY-1570 and ECY-1570K
Reason
The video cytoscopes lack 510(k) premarket notification clearance.
Identifiers
| code_info | Serial number: J110097 J110101 G110053 G110051 G110052 G110054 G110015 G110084 H110086 H110088 J110062 G1100…Serial number: J110097 J110101 G110053 G110051 G110052 G110054 G110015 G110084 H110086 H110088 J110062 G110016 G110039 G110048 G110049 G110038 J110061 G110021 J110078 G110056 G110057 G110073 G110037 G110058 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0615-2018%22
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