Pentax Medical Video Processor Recalled for Uncleared Water Bottle Assembly
Pentax Medical is recalling Video Processor EPK-i5010 units because they were 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 hospitalizations. The hazard is a regulatory compliance issue (uncleared component) rather than a direct physical safety defect with reported harm, fitting the criteria for a moderate severity score.
Plain-English summary
Pentax Medical Company is recalling the Video Processor EPK-i5010. 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 affects 819 units distributed nationwide in the US. The source text does not specify which specific models of the Ultrasound Gastroscope are directly involved in this specific recall of the Video Processor, though the product information lists several associated models.
Consumers should stop using the affected Video Processor EPK-i5010 units and contact Pentax Medical Company for instructions on how to proceed.
The recalled product
- Product
- Ultrasound Gastroscope Product Usage: Intended to provide optical visualization of, ultrasonic Visualization of, and therapeutic access to the Upper Gastrointestinal Tract including but not restricted to, the organs; tissues; and subsystems: Esophagus, Stomach, Duodenum, Smal
- Manufacturer
- Pentax Medical Company
- Affected units
- 819
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 (7)
- Model #'s EG-3630U
- FG-38UX
- EG-3630UR
- FG-34UX
- FG-36UX
- EG-3830UT
- EG-3670URK and EG-3870UTK.
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
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