Z-0615-2018Class II

Video Cystoscope models ECY-1570 and ECY-1570K

Name: Z-0615-2018 Video Cystoscope models ECY-1570 and ECY-1570K
Creator: Pentax of America Inc
Published: 2017-07-13
License: https://open.fda.gov/license/

PENTAX of America, Inc. / initiated 2017-07-13 / Terminated

FDA source

Pentax of America Inc began a recall of Video Cystoscope models ECY-1570 and ECY-1570K on 2017-07-13. FDA classified it as Class II and gives the reason as "The video cytoscopes lack 510(k) premarket notification clearance". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0615-2018
Classification: Class II
Status: Terminated
Initiated: 2017-07-13
Posted: 2018-02-14
Terminated: 2019-07-22
Recalling firm: PENTAX of America, Inc.
Product: Video Cystoscope models ECY-1570 and ECY-1570K
Product code: FAJ Cystoscope And Accessories, Flexible/Rigid
Reason for recall: The video cytoscopes lack 510(k) premarket notification clearance.
FDA root cause: No Marketing Application
Action: Customer Instructions: Customers should inspect their stock of PENTAX Medical ECY-1570 and ECY-1570K video cystoscopes, quarantine them, and discontinue use of these products. If you have sold and distributed these products, please provide a copy of the notice and response form to the new owners. Enclosed with this letter is a customer response form. The form identifies the affected endoscopes (model and serial numbers) which have been sold to your facility. The attached form should be completed and returned to PENTAX Medical. Contact Information: If you have any questions regarding this action, please feel free to contact PENTAX Medical Customer Service. Tel: 800-431-5880 (8:30 AM 5:00 PM, Monday Friday, EST) Fax: 201-799-4063 (alternate 201-391-4189) Email: [email protected]
Quantity in commerce: 24
Distribution: Distributed in 8 states: CA, IL, MD, MI, ND, NH, NY, SD, and Guam.
Product codes and lots: 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

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0615-2018
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0615-2018	Class II	Terminated	Voluntary: Firm initiated	2018-02-21	2018-02-14

Product code FAJ

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)