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Open, Classified

BRONCHOVIDEOSCOPE OLYMPUS BF-1TQ170

FDA Recall Z-0050-2026 · Posted 2025-10-16

Recall StatusOpen, Classified
Product CodeEOQ
Date Initiated2025-09-11
Product Quantity0 units US; 2,092 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.

Firm Action

An URGENT Medical Device Correction notification dated 9/11/25 was mailed to consignees to notify them of this recall action. Consignees are asked to carefully read the recall notification and identify any affected devices in their inventory. Consignees are to ensure all personnel are knowledgeable and aware of the updated IFU. Consignees are to acknowledge receipt of the recall notification through Olympus' web portal at https://olympusamerica.com/recall. Forward the provided recall notification if product was further distributed. Consignees with any questions can contact Cynthia Ow by phone at 647-999-3203 or by email at [email protected].

Root Cause

Device Design

Distribution Pattern

US Nationwide Distribution.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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