Pentax of America Inc: Medical Device Recall in 2018 - (Recall #: Z-0615-2018)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2018.

Data Source: FDA.

Product Description:

Video Cystoscope models ECY-1570 and ECY-1570K

Product Classification:

Class II

Date Initiated: July 13, 2017

Date Posted: February 21, 2018

Recall Number: Z-0615-2018

Event ID: 79131

Reason for Recall:

The video cytoscopes lack 510(k) premarket notification clearance.

Status: Terminated

Product Quantity: 24

Code Information:

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

Distribution Pattern:

Distributed in 8 states: CA, IL, MD, MI, ND, NH, NY, SD, and Guam.

Voluntary or Mandated:

Voluntary: Firm initiated