Confocal GI Scope Product Usage: Intended to provide optical… — Class II medical device recall Z-2276-2016
Terminated recall by Pentax Medical Company, reported 2016-08-03, distributed nationwide. Pentax Medical Video Processor EPK-i5010 has been shipped with a reusable Pentax Medical water bottle assembly
| Recall number | Z-2276-2016 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Pentax Medical Company, Montvale, NJ, United States |
| Recall initiated | 2016-04-06 |
| Classified | 2016-07-22 |
| Reported by FDA | 2016-08-03 |
| Terminated | 2017-07-17 |
| Distributed | Nationwide (US) |
| Quantity | 17 units |
| Model numbers | EC-3870CIK, EG-3870CIK |
Product
Confocal GI Scope Product Usage: Intended to provide optical visualization of and therapeutic access to the Gastrointestinal Tract. This anatomy includes, but is not restricted to, the organs; tissues; and subsystems: Esophagus, Stomach, Duodenum, and Large Bowel to the Cecum. The instrument is introduced via the mouth or rectum as decided by the the anatomy being accessed when indications consistent with the need for procedure are observed in adult and pediatric patient populations.
Reason for recall
Pentax Medical Video Processor EPK-i5010 has been shipped with a reusable Pentax Medical water bottle assembly (OS-H4) which has not been cleared for use with this devices in the United States.
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.