Aizu Olympus Co., Ltd.: Medical Device Recall in 2023 - (Recall #: Z-0419-2024)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2023.

Data Source: FDA.

Product Description:

PCF-H190L, EVIS EXERA III COLONOVIDEOSCOPE

Product Classification:

Class II

Date Initiated: October 16, 2023

Date Posted: December 6, 2023

Recall Number: Z-0419-2024

Event ID: 93335

Reason for Recall:

Specific devices may have an improperly repaired light guide connector due to missing adhesive to secure the suction channel mouthpiece to the scope connector. Issue may result in loss of image, decreased suction, or impact the ability to effectively reprocess the device. This in turn may lead to unanticipated delay to treatment, or patient exposure to contaminated material and subsequent infection.

Status: Ongoing

Product Quantity: 24 incorrectly repaired units

Code Information:

UDI-DI 04953170305191 Serial Numbers 2302719, 2516751

Distribution Pattern:

Domestic distribution to FL, KY, MA, NJ, NY, and PA

Voluntary or Mandated:

Voluntary: Firm initiated