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.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
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.…
- 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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See all →- ModeratePentax Medical Video Processor Recalled for Uncleared Water Bottle Assembly
FDA (Devices) · 2016-08-03
- ModeratePentax Medical Video Processor Recalled for Uncleared Water Bottle Assembly
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- ModeratePentax Medical Video Processor Recalled for Uncleared Water Bottle Assembly
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