BRONCHOVIDEOSCOPE OLYMPUS BF TYPE 1T150

FDA Recall #Z-0045-2026 — Class I — September 11, 2025

Recall #Z-0045-2026 Date: September 11, 2025 Classification: Class I Status: Ongoing

Product Description

BRONCHOVIDEOSCOPE OLYMPUS BF TYPE 1T150

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.

Recalling Firm

Olympus Corporation of the Americas — Center Valley, PA

Classification

Class I — Reasonable probability of serious adverse health consequences or death.

Product Type

Devices

Product Quantity

3 units US; 1,987 units OUS

Distribution

US Nationwide Distribution.

Code Information

Model No. BF-1T150; UDI: 4953170308185; All Serial No.

Status

Ongoing

Voluntary / Mandated

Voluntary: Firm initiated