Olympus Corporation of the Americas: Medical Device Recall in 2025 - (Recall #: Z-0053-2026)

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:

EVIS EXERA III BRONCHOVIDEOSCOPE OLYMPUS BF-H190

Product Classification:

Class I

Date Initiated: September 11, 2025

Date Posted: October 22, 2025

Recall Number: Z-0053-2026

Event ID: 97441

Reason for Recall:

Additional IFU updates to provide further clarification on safe and effective use of bronchoscopes when used in conjunction with laser, argon plasma coagulation, and high-frequency therapy equipment.

Status: Ongoing

Product Quantity: 5,221 units US; 4,321 units OUS

Code Information:

Model No. BF-H190; UDI: 4953170335174; All Serial No.

Distribution Pattern:

US Nationwide Distribution.

Voluntary or Mandated:

Voluntary: Firm initiated