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. The hazard involves the use of an uncleared accessory component rather than a direct defect causing injury or death, fitting the criteria for moderate severity involving regulatory compliance and potential misuse.
Plain-English summary
Pentax Medical Company is recalling the Pentax Medical 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 affected product is the Pentax Medical Video Processor EPK-i5010. The recall involves 10,074 units that were distributed nationwide in the United States. The issue is specifically related to the inclusion of the OS-H4 water bottle assembly, which lacks the necessary clearance for use with the video processor in the US market.
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 with the recall and replacement or removal of the uncleared component.
The recalled product
- Product
- Gastroscope Product Usage: Intended to provide optical visualization of and therapeutic access to the Upper Gastrointestinal Tract. This anatomy includes, but is not restricted to, the organs; tissues; and subsystems: Esophagus, Stomach and Duodenum. The instrument is…
- Manufacturer
- Pentax Medical Company
- Affected units
- 10,074
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 (20)
- Model #'s FG-16V
- FG-24V
- FG-29V
- EE-1540
- EE-1580K
- EG-1540
- EG-1580K
- EG-1840
- EG-2540
- EG-2940
- EG-3840T
- EG-3831T
- EG-3870TK
- EG-1870K
- EG-2470K
- EG-2530
- EG-2730K
- EG-2731
- EG-2770K
- EG-290KP
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
Same manufacturer · Pentax Medical Company
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
FDA (Devices) · 2016-08-03
- 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
FDA (Devices) · 2016-08-03
- ModeratePentax Medical Video Processor Recalled for Uncleared Water Bottle Assembly
FDA (Devices) · 2016-08-03
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