The Recall Desk
HighFDA (Devices)·Z-2074-2016·Announced 2016-07-06

Pentax Naso-Pharyngo-Laryngoscope Recall Due to Lodged Accessories

Pentax Medical Company is recalling 215 Naso-Pharyngo-Laryngoscopes 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 functional defect (lodged accessories) poses a risk of harm during procedures, 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 215 units of Naso-Pharyngo-Laryngoscopes. The affected models are FNL-10RAP, FNL-13RAP, FNL-15RP3, and VNL-1530T. These devices are intended to provide optical visualization and therapeutic access to the upper airway, including the ear, nasal passage, and trachea, for adult and pediatric patients.

The recall is being issued because Pentax has become 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. This issue affects devices distributed nationwide in the United States, including Puerto Rico, as well as internationally to Denmark and Guam.

Healthcare providers and facilities using these specific models should stop using the affected devices and contact Pentax Medical Company for further instructions on the recall process.

The recalled product

Product
Naso-Pharyngo-Laryngoscope Intended to provide optical visualization of, therapeutic access to, the Upper Airway. This anatomy includes, but is not restricted to, the organs, tissues and subsystems: Ear, Nasal Passage and Trachea. The instrument is introduced via the mouth or th
Manufacturer
Pentax Medical Company
Category
Medical Device — Endoscope
Hazard
Affected units
215

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 FNL-10RAP
  • FNL-13RAP
  • FNL-15RP3 and VNL-1530T

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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