EVIS EXERA b BRONCHOVIDEOSCOPE OLYMPUS BF-XT190
FDA device recall Z-0066-2026 · posted 2025-10-16 · Open, Classified
Recall details
- Recalling firm
- Olympus Corporation of the Americas
- 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.
- Action taken
- 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 Cynthia.Ow@olympus.com.
- Root cause
- Device Design
- Status
- Open, Classified
- Product code
- EOQ
- Quantity affected
- 361 units US; 258 units OUS
- Distribution
- US Nationwide Distribution.
- Date initiated
- 2025-09-11
- Date posted
- 2025-10-16
- Location
- Center Valley, PA
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