The Recall Desk
HighFDA (Devices)·Z-2076-2016·Announced 2016-07-06

Pentax Ultrasound Bronchoscopes Recalled for Lodged Accessories Risk

Pentax Medical is recalling 115 Ultrasound Bronchoscopes 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 with a risk of harm (lodged accessories) where no specific injuries or illnesses are reported in the source text, fitting the High severity criteria for risk-of-harm products without reported injury.

Plain-English summary

Pentax Medical Company is recalling 115 units of the Ultrasound Bronchoscope, Model #EB-1970UK. The device is intended to provide optical and ultrasonic visualization and therapeutic access to the pulmonary tract in adult and pediatric patients.

The recall was initiated because 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 units were distributed nationwide in the United States, including Puerto Rico, and internationally to Denmark and Guam.

Healthcare providers should stop using the affected devices and contact Pentax Medical Company for further instructions regarding the recall.

The recalled product

Product
Ultrasound Bronchoscope Intended to provide optical visualization of, ultrasonic visualization of and therapeutic access to, the Pulmonary Tract including but not restricted to organs, tissues and subsystems: Nasal Passage, Pharynx, Larynx, Trachea, Bronchial Tree (including acc
Manufacturer
Pentax Medical Company
Category
Medical Device — Endoscopy
Hazard
Affected units
115

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 #EB-1970UK

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

Same manufacturer · Pentax Medical Company

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Same hazard · lodged accessory

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