Pentax Medical Video Processor- Intended to be used with PENTAX… — Class II medical device recall Z-1238-2025
Ongoing recall by Pentax of America Inc, reported 2025-03-05, distributed nationwide. During endoscopic procedures using a combination of the video processor EPK-i8020c and the i20c series video e
| Recall number | Z-1238-2025 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Pentax of America Inc, Montvale, NJ, United States |
| Recall initiated | 2025-01-29 |
| Classified | 2025-02-26 |
| Reported by FDA | 2025-03-05 |
| Distributed | Nationwide (US) |
| Quantity | 94 units |
| UPC / GTIN / UDI-DI | 04961333247974 |
| Serial numbers | B0023Z1193, B0023Z1195, B0023Z1245, B0023Z1247, B0023Z1250, B0023Z1255, B0023Z1256, B0023Z1276, B0023Z1277, B0023Z1279, B0023Z1280, B0023Z1286, B0023Z1290, B0023Z1296, B0023Z1313, B0023Z1335, B0023Z1451, B0023Z1461, B0023Z1478, B0023Z1481, B0023Z1565, B0023Z1573, B0023Z1628, B0023Z1631, B0023Z1637 and 69 more |
| Model numbers | EPK-I8020C |
Product
Pentax Medical Video Processor- Intended to be used with PENTAX Medical endoscopes, monitors and other peripheral devices for endoscopic diagnosis, treatment, and video observation. Model: EPK-i8020c
Reason for recall
During endoscopic procedures using a combination of the video processor EPK-i8020c and the i20c series video endoscope, the observed image can become reddish or dark (1.8%). Users have observed smoke-like steam and noted that the light guide at the tip is hot during use / after the endoscope is removed from the patient, and may cause thermal injury to the patient's mucous membranes.
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-1238-2025. 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.