EVIS EXERA III BRONCHOVIDEOSCOPE OLYMPUS BF-P190
FDA Recall Z-0057-2026 · Posted 2025-10-16
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Recalling FirmOlympus Corporation of the Americas
Recall StatusOpen, Classified
Product CodeEOQ
Date Initiated2025-09-11
Product Quantity3,046 units US; 2,414 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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