Video Cystoscope recall
Video Cystoscope models ECY-1570 and ECY-1570K
Why was Video Cystoscope recalled?
The video cytoscopes lack 510(k) premarket notification clearance.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
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
- Product
- Video Cystoscope models ECY-1570 and ECY-1570K
- Recalling firm
- Pentax of America Inc
- Quantity
- 24
- Distribution
- Distributed in 8 states: CA, IL, MD, MI, ND, NH, NY, SD, and Guam.
- Recall date
- February 21, 2018
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)