The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Devices)·Z-2280-2016·Announced 2016-08-03

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, which typically indicates a situation where use of the product may cause temporary or medically reversible health consequences. The hazard is the use of an uncleared component, which is a regulatory compliance issue rather than a direct, reported physical injury or high-risk pathogen exposure.

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 the specific water bottle assembly (OS-H4) included with the processor. The source text does not specify the number of units affected or the specific distribution locations beyond the general context of US clearance.

Consumers and healthcare facilities should stop using the water bottle assembly (OS-H4) with the EPK-i5010 Video Processor. Users should contact Pentax Medical Company for further instructions regarding the replacement or return of the uncleared component.

The recalled product

Product
Signmoidoscope Product Usage: Intended to provide optical visualization of, therapeutic access to the Lower Gastrointestinal Tract. This anatomy includes, but is not restricted to, the organs; tissues; and subsystems: Large Bowel to the Sigmoid Colon. The instrument is…
Manufacturer
Pentax Medical Company
Category
Medical Device — Endoscopy Equipment
Hazard

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 (3)

  • Model #'s FS-34V
  • ES-3831
  • ES-3870K and ES-3840

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 →

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