Home / Recalls / Olympus Corporation of the Americas / Z-0066-2026

Z-0066-2026 Class I Ongoing

Recalled by Olympus Corporation of the Americas — Center Valley, PA

Recall Details

Product Type
Devices
Report Date
October 22, 2025
Initiation Date
September 11, 2025
Termination Date
N/A
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
361 units US; 258 units OUS

Product Description

EVIS EXERA b BRONCHOVIDEOSCOPE OLYMPUS BF-XT190

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.

Distribution Pattern

US Nationwide Distribution.

Code Information

Model No. BF-XT190; UDI: 4953170402470; All Serial No.

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  • Z-1271-2026 Class II — Product Name: Single Use 3-Lumen Sphincterotome V Model/Catalog Number: KD-V41 (January 7, 2026)