The Recall Desk
HighFDA (Devices)·Z-2066-2016·Announced 2016-07-06

Pentax Choledocho-Nephroscope Recalled Due to Lodged Accessories in Instrument Channel

Pentax Medical is recalling 126 Choledocho-Nephroscope units 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 is classified as FDA Class II and involves a risk-of-harm product where injury has not yet been reported, meeting the criteria for a High severity score.

Plain-English summary

Pentax Medical Company is recalling 126 units of the Choledocho-Nephroscope, models ECN-1530 and FCN-15X. The device is intended to provide optical visualization and therapeutic access to the abdominal cavity, including the biliary tree and renal cavity, for 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. This issue affects units distributed nationwide in the United States, including Puerto Rico, as well as internationally to Denmark and Guam.

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

The recalled product

Product
Choledocho-Nephroscope Intended to provide optical visualization of and therapeutic access to the Abdominal Cavity. This anatomy includes, but is not restricted to, the organs, tissues and subsystems: Biliary tree with access to the Common bile Duct, Hepatic Duct, Cystic Duct, K
Manufacturer
Pentax Medical Company
Category
Medical Device — Endoscope
Hazard
Affected units
126

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 ECN-1530 and FCN-15X

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

See all →

Same hazard · lodged accessory

See all →