Video Duodenoscope — Class II medical device recall Z-1835-2016
Terminated recall by Pentax Medical Company, reported 2016-06-08, distributed nationwide. Pentax Medical learned of reports of carbapenem-resistant Enterobacteriaceae (CRE) infection at a medical faci
| Recall number | Z-1835-2016 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Pentax Medical Company, Montvale, NJ, United States |
| Recall initiated | 2016-02-22 |
| Classified | 2016-05-27 |
| Reported by FDA | 2016-06-08 |
| Terminated | 2017-12-06 |
| Distributed | Nationwide (US) |
| Quantity | 423 units |
Product
Video Duodenoscope
Reason for recall
Pentax Medical learned of reports of carbapenem-resistant Enterobacteriaceae (CRE) infection at a medical facility.
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-1835-2016. 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.