Pentax of America Inc: Medical Device Recall in 2016 - (Recall #: Z-2875-2016)

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:

Pentax Video Bronchoscope Designed to be used with a Pentax Video Processor (including light source), documentation equipment, video monitor, endo-therapy accessories (such as biopsy forceps) and other ancillary equipment for endoscopy and endoscopic surgery within the airways and tracheobronchial tree.

Product Classification:

Class II

Date Initiated: May 31, 2016

Date Posted: September 28, 2016

Recall Number: Z-2875-2016

Event ID: 74954

Reason for Recall:

Pentax America Inc. is recalling various bronchoscopes which contain an incorrect Operation and Reprocessing IFUS.

Status: Terminated

Product Quantity: 1719 units

Code Information:

EB-1170K; EB-1570K; EB-1575K; EB=1970K; EB-1970TK; EB-1975K

Distribution Pattern:

Nationwide Distribution

Voluntary or Mandated:

Voluntary: Firm initiated