Pentax Medical Video Processor Recalled for Uncleared Water Bottle Assembly
Pentax Medical is recalling the EPK-i5010 Video Processor because it was shipped with a water bottle assembly not cleared for use in the United States.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, but the source text does not report any illnesses, injuries, or specific health hazards, indicating a regulatory compliance issue rather than a direct safety threat.
Plain-English summary
Pentax Medical Company is recalling the EPK-i5010 Video Processor. The recall is due to the device being shipped with a reusable Pentax Medical water bottle assembly (OS-H4) that has not been cleared for use with this device in the United States.
The recall involves 433 units of the EPK-i5010 Video Processor, specifically models FD-34V and ED-3490TK. These units were distributed nationwide in the United States.
Healthcare facilities and users should stop using the affected water bottle assembly with the EPK-i5010 Video Processor. Users should contact Pentax Medical Company for further instructions on how to proceed.
The recalled product
- Product
- Duodenoscope 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
- Manufacturer
- Pentax Medical Company
- Affected units
- 433
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- Model #'s FD-34V and ED-3490TK
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 6 recalled by Pentax Medical Company under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 6 products in this recall →Related recalls
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