PENTAX Medical Video Colonoscope- Intended to provide optical… — Class II medical device recall Z-1236-2025
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-1236-2025 |
|---|---|
| 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 | 152 units |
| UPC / GTIN / UDI-DI | 04961333252169 |
| Serial numbers | A002FA0230, A002FA0244, A002FA0246, A002FA0247, A002FA0248, A002FA0259, A002FA0269, A002FA0271, A002FA0272, A002FA0274, A002FA0275, A002FA0278, A002FA0281, A002FA0282, A002FA0283, A002FA0293, A002FA0294, A002FA0299, A002FA0300, A002FA0301, A002FA0303, A002FA0304, A002FA0306, A002FA0307, A002FA0311 and 127 more |
| Model numbers | EC38-I20CL |
Product
PENTAX Medical Video Colonoscope- Intended to provide optical visualization of (via a video monitor), and therapeutic access to the lower gastrointestinal tract Model: EC38-i20cL
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.