FDA Device Recall Z-0048-2026

Olympus Corporation of the Americas · Center Valley, PA

Class I — life-threatening Ongoing

Highest impact — Class I device recall — FDA determination that use of, or exposure to, the device will cause serious adverse health consequences or death. Distribution is nationwide and the recall remains in progress.

Device

BRONCHOVIDEOSCOPE OLYMPUS BF-1TH1100

Lot / serial / GTIN: Model No. BF-1TH1100; UDI: 4953170424199; All Serial No.

Quantity: 0 units US; 1,913 units OUS

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.

Recall record

Recall number: Z-0048-2026
Classification: Class I
Status: Ongoing
Voluntary or mandated: Voluntary: Firm initiated
Distribution: US Nationwide Distribution.
Recall initiated: 2025-09-11
Classified by FDA Center: 2025-10-16
FDA published: 2025-10-22
Recalling firm: Olympus Corporation of the Americas
Firm location: Center Valley, PA

Operational response

A Class I device recall indicates a strong likelihood of serious adverse health consequence or death from continued use. Identify affected units by serial number, lot, or GTIN against your inventory and against implanted-device patient registry. Pull affected inventory from active use immediately. For implanted devices, follow the recalling firm’s patient-notification protocol; in most cases this requires informing affected patients and their treating physicians directly.

For the official FDA enforcement record, see FDA's Recall Search.

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