Cystoscope Intended to provide optical visualization of and… — Class II medical device recall Z-2070-2016
Terminated recall by Pentax Medical Company, reported 2016-07-06, distributed nationwide. Pentax has become aware that operational/cleaning accessories and therapeutic devices (e.g., clips, stents, ba
| Recall number | Z-2070-2016 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Pentax Medical Company, Montvale, NJ, United States |
| Recall initiated | 2016-04-06 |
| Classified | 2016-06-28 |
| Reported by FDA | 2016-07-06 |
| Terminated | 2017-12-21 |
| Distributed | Nationwide (US) |
| Countries outside the US | DK |
| Quantity | 120 units |
| Model numbers | ECY-1530, ECY-1570K, FCY-15P2, FCY-15RBS |
Product
Cystoscope Intended to provide optical visualization of and therapeutic access to the Urinary Tract. This anatomy includes, but is not restricted to, the organs, tissues and subsystems: Urethra to the Bladder. The instrument is introduced via the urethra when indications consistent with the need for procedure are observed in adult and pediatric patient populations.
Reason for recall
Pentax has become aware that operational/cleaning accessories and therapeutic devices (e.g., clips, stents, balloons, etc.) can become lodged in an endoscope's instrument channel.
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-2070-2016. 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.