Aizu Olympus Co., Ltd.: Medical Device Recall in 2025 - (Recall #: Z-0872-2026)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2025.

Data Source: FDA.

Product Description:

Olympus OER-Elite

Product Classification:

Class II

Date Initiated: October 31, 2025

Date Posted: December 10, 2025

Recall Number: Z-0872-2026

Event ID: 97849

Reason for Recall:

Inform existing affected device customers about pertinent Warnings/Cautions, existing recommended maintenance schedules and that only properly trained personnel conduct repairs and maintenance.

Status: Ongoing

Product Quantity: 6578 units

Code Information:

Model: OER-Elite; UDI: 04953170404047; Serial #: All;

Distribution Pattern:

US Nationwide distribution.

Voluntary or Mandated:

Voluntary: Firm initiated