The Recall Desk
HighFDA (Devices)·Z-2073-2016·Announced 2016-07-06

Pentax Laryngo Stroboscope Recalled Due to Lodged Accessories Risk

Pentax Medical Company is recalling 206 Laryngo Stroboscopes because operational and therapeutic accessories can become lodged in the instrument channel.

What this means for you

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 involves a medical device where a mechanical defect (lodged accessories) poses a risk of harm during a procedure, but the source text does not report any specific injuries or illnesses, fitting the 'High' severity criteria for risk-of-harm products without reported injury.

Plain-English summary

Pentax Medical Company is recalling 206 units of the Laryngo Stroboscope (Model #VNL-1570STK). The recall is due to a risk that operational, cleaning, and therapeutic accessories, such as clips, stents, and balloons, can become lodged in the endoscope's instrument channel.

The affected devices are intended to provide optical visualization and therapeutic access to the upper airway and vocal folds in adult and pediatric patients. The products were distributed nationwide in the United States, including Puerto Rico, as well as internationally to Denmark and Guam.

Pentax Medical Company is the recalling firm. The source text does not specify specific actions for consumers or healthcare providers, nor does it report any specific injuries or illnesses associated with this defect.

The recalled product

Product
Laryngo Stroboscope Product Usage Intended to provide optical visualization of, therapeutic access to, the Upper Airway and Vocal Folds. This anatomy includes, but is not restricted to, the organs, tissues and subsystems: Larynx, Pharynx and Vocal Cords. The instrument is introd
Manufacturer
Pentax Medical Company
Category
Medical Device — Endoscope
Hazard
Affected units
206

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 #VNL-1570STK

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 →

Related recalls

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Same hazard · lodged accessory

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