Pentax Medical Video Processor — Class II medical device recall Z-2329-2025
Ongoing recall by Pentax of America Inc, reported 2025-08-27, distributed in AZ, CA, DC, FL, IA, ID, IL, KS…. During endoscopic procedures using a combination of the video processor EPK-i8020c and i20c series video endos
| Recall number | Z-2329-2025 |
|---|---|
| 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 | 2025-07-16 |
| Classified | 2025-08-15 |
| Reported by FDA | 2025-08-27 |
| Distributed | AZ, CA, DC, FL, IA, ID, IL, KS, MA, MD, MI, MO, NC, NJ, NM, NY, OK, PA, TX, WA |
| Quantity | 144 units |
| UPC / GTIN / UDI-DI | 04961333247974 |
| Serial numbers | B0023Z1193, B0023Z1195, B0023Z1243, B0023Z1245, B0023Z1247, B0023Z1250, B0023Z1255, B0023Z1256, B0023Z1258, B0023Z1276, B0023Z1277, B0023Z1279, B0023Z1280, B0023Z1285, B0023Z1286, B0023Z1287, B0023Z1288, B0023Z1289, B0023Z1290, B0023Z1291, B0023Z1296, B0023Z1335, B0023Z1451, B0023Z1461, B0023Z1478 and 119 more |
| Model numbers | EPK-I8020C |
Product
Pentax Medical Video Processor; Model Number: EPK-i8020c;
Reason for recall
During endoscopic procedures using a combination of the video processor EPK-i8020c and i20c series video endoscope, the observed image can become reddish or dark. 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 membrane.
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-2329-2025. 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.