PENTAX Medical Video Upper GI Scope-Intended to provide optical… — Class II medical device recall Z-1237-2025
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-1237-2025 |
|---|---|
| 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 | 138 units |
| UPC / GTIN / UDI-DI | 04961333252145 |
| Serial numbers | A0038A0431, A0038A0433, A0038A0435, A0038A0447, A0038A0451, A0038A0452, A0038A0454, A0038A0458, A0038A0460, A0038A0474, A0038A0475, A0038A0479, A0038A0486, A0038A0488, A0038A0489, A0038A0492, A0038A0494, A0038A0496, A0038A0497, A0038A0500, A0038A0502, A0038A0503, A0038A0507, A0038A0513, A0038A0514 and 113 more |
| Model numbers | EG29-I20C |
Product
PENTAX Medical Video Upper GI Scope-Intended to provide optical visualization of (via a video monitor), and therapeutic access to the lower gastrointestinal tract Model: EG29-i20c
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
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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.