Pentax of America Inc: Medical Device Recall in 2020 - (Recall #: Z-1267-2020)

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: EC34-i10L

Product Classification:

Class II

Date Initiated: January 3, 2020

Date Posted: February 26, 2020

Recall Number: Z-1267-2020

Event ID: 84735

Reason for Recall:

Distributed in the USA without an approved 510K

Status: Terminated

Product Quantity:

Code Information:

Serial Numbers: L110300, L110301, L110303, L110306

Distribution Pattern:

NC, MA

Voluntary or Mandated:

Voluntary: Firm initiated