OES BRONCHOFIBERSCOPE OLYMPUS BF TYPE P60
This recall is currently active, issued October 16, 2025. It was issued by Olympus Corporation Of The Americas.
- Recall Initiated
- September 11, 2025
- Posted
- October 16, 2025
- Recall Number
- Z-0058-2026
- Quantity
- 1,007 units US; 5,443 units OUS
- Firm Location
- Center Valley, PA
- Official Source
- View on FDA website ↗
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
US Nationwide Distribution.
Lot / Code Info
Model No. BF-P60; UDI: 4953170339196; All Serial No.
Root Cause
Device Design
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.