Pentax Medical Company: Medical Device Recall in 2016 - (Recall #: Z-2076-2016)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2016.

Data Source: FDA.

Product Description:

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 access beyond the stem), and underlying areas. The instrument is introduced orally when indications consistent with the requirement for procedure are observed in adult and pediatric patient populations

Product Classification:

Class II

Date Initiated: April 6, 2016

Date Posted: July 6, 2016

Recall Number: Z-2076-2016

Event ID: 73894

Reason for Recall:

Pentax has become aware that operational/cleaning accessories and therapeutic devices (e.g., clips, stents, balloons, etc.) can become lodged in an endoscope's instrument channel.

Status: Terminated

Product Quantity: 115 units

Code Information:

Model #EB-1970UK

Distribution Pattern:

Worldwide Distribution - US (Nation Wide) including Puerto Rico and Internationally to Denmark, Guam

Voluntary or Mandated:

Voluntary: Firm initiated