Pentax Video Gastroscope is intended to be used with a Pentax video… — Class II medical device recall Z-0318-2017
Terminated recall by Pentax of America Inc, reported 2016-11-02, distributed nationwide. PENTAX Medical is initiating this field action to provide customers that have purchased the affected endoscope
| Recall number | Z-0318-2017 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Pentax of America Inc, Montvale, NJ, United States |
| Recall initiated | 2016-08-15 |
| Classified | 2016-10-26 |
| Reported by FDA | 2016-11-02 |
| Terminated | 2019-04-23 |
| Distributed | Nationwide (US) |
| Countries outside the US | JP |
Product
Pentax Video Gastroscope is intended to be used with a Pentax video processor (including light source), documentation equipment, monitor, EndoTherapy Device such as a Biopsy Forceps, and other ancillary equipment for endoscopy and endoscopic surgery within the upper digestive tract including the esophagus, stomach and duodenum.
Reason for recall
PENTAX Medical is initiating this field action to provide customers that have purchased the affected endoscopes with the most recent Operation and Reprocessing IFUs.
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-0318-2017. 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.