The Recall Desk
Agency classClass IIOur severity:HighFDA (Devices)·Z-2080-2016·Announced 2016-07-06

Pentax Small Bowel Scope Recall Due to Lodged Accessories

Pentax Medical Company is recalling 96 Small Bowel Scopes because operational and cleaning accessories can become lodged in the instrument channel.

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 3/5 (High).

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall is classified as FDA Class II, and the hazard involves a risk of harm (lodged accessories) where specific injury reports are not detailed in the source text, fitting the 'High' severity criteria for risk-of-harm products.

Plain-English summary

Pentax Medical Company is recalling 96 units of the Small Bowel Scope, model VSB-3430. The recall was initiated because the company became aware that operational and cleaning accessories, as well as therapeutic devices such as clips, stents, and balloons, can become lodged in the endoscope's instrument channel.

The affected devices were distributed nationwide in the United States, including Puerto Rico, and internationally to Denmark and Guam. The product is used for gastrointestinal procedures in adult and pediatric patient populations.

Consumers and healthcare providers should stop using the affected devices and contact Pentax Medical Company for instructions on how to proceed with the recall.

The recalled product

Product
Small Bowel Scope Gastrointestinal Tract. This anatomy includes, but is not restricted to, the organs, tissues and subsystems: Esophagus, Stomach and Duodenum. The instrument is introduced via the mouth when indications consistent with the need for procedure are observed in…
Manufacturer
Pentax Medical Company
Category
Medical Device — Endoscopy
Hazard
Affected units
96

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 #VSB-3430

Distribution

Distributed in 2 states:

Part of a larger recall action

This product is one of 16 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 16 products in this recall →

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