The Recall Desk
HighFDA (Devices)·Z-2078-2016·Announced 2016-07-06

Pentax Medical Recalls Ureteroscopes Due to Lodged Accessories Risk

Pentax Medical is recalling 32 ureteroscopes because operational accessories may 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 risk-of-harm product where injury has not yet been reported, fitting the criteria for a High severity score.

Plain-English summary

Pentax Medical Company is recalling 32 units of Ureteroscopes, models FUR-9P and FUR-9RBS. The recall is due to a risk that operational/cleaning accessories and therapeutic devices, such as clips, stents, or balloons, can become lodged in the endoscope's instrument channel.

The affected devices are intended to provide optical visualization of and therapeutic access to the urinary track, including the urethra, bladder, and renal pelvis. The instruments are introduced via the urethra for adult and pediatric patient populations.

The recall covers units distributed nationwide in the United States, including Puerto Rico, as well as internationally to Denmark and Guam. Users should stop using the affected devices and contact Pentax Medical Company for further instructions.

The recalled product

Product
Ureteroscope Intended to provide optical visualization of and therapeutic access to the Urinary Track. This anatomy includes but is not restricted to the organs, tissues and subsystems: Urethra, Bladder and Renal Pelvis. The instrument is introduced via the urethra when indicati
Manufacturer
Pentax Medical Company
Category
Medical Device — Endoscopes
Hazard
Affected units
32

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 #'s FUR-9P and FUR-9RBS

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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