The Recall Desk
ModerateFDA (Devices)·Z-2276-2016·Announced 2016-08-03

Pentax Medical Video Processor Recalled for Uncleared Water Bottle Assembly

Pentax Medical is recalling Video Processor EPK-i5010 units shipped with a water bottle assembly not cleared for US use.

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. The hazard involves the use of an uncleared accessory, which is a regulatory and potential safety issue, but the source text does not report any illnesses, injuries, or deaths, fitting the criteria for a moderate severity score.

Plain-English summary

Pentax Medical Company is recalling 17 units of 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 affected units were distributed nationwide in the US. The recall involves specific models of the Confocal GI Scope, specifically the EG-3870CIK and EC-3870CIK, which are intended to provide optical visualization and therapeutic access to the gastrointestinal tract.

Consumers and healthcare providers should stop using the affected water bottle assembly with the Video Processor EPK-i5010. The source text does not specify further consumer actions or contact information for the recall.

The recalled product

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
Manufacturer
Pentax Medical Company
Category
Medical Device — Endoscopy Equipment
Hazard
Affected units
17

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 EG-3870CIK and EC-3870CIK

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 →