Pentax of America Inc: Medical Device Recall in 2020 - (Recall #: Z-1268-2020)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2020.

Data Source: FDA.

Product Description:

Pentax Video Colonoscope Model: EC38-i10L

Product Classification:

Class II

Date Initiated: January 3, 2020

Date Posted: February 26, 2020

Recall Number: Z-1268-2020

Event ID: 84735

Reason for Recall:

Distributed in the USA without an approved 510K

Status: Terminated

Product Quantity: 1 unit

Code Information:

Serial Numbers:L110746

Distribution Pattern:

NC, MA

Voluntary or Mandated:

Voluntary: Firm initiated