FDA Medical Device Recalls (openFDA)
Olympus Corporation of the Americas: BRONCHOFIBERSCOPE OLYMPUS BF TYPE TE2
- Recall number
- Z-0064-2026
- Recalling firm
- Olympus Corporation of the Americas
- Product
- BRONCHOFIBERSCOPE OLYMPUS BF TYPE TE2
- Status
- Open, Classified
- Initiated
- 2025-09-11
- Posted
- 2025-10-16
- Terminated
- not on file
- Reason
- 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.
- Root cause
- Device Design
- 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 Cynthia.Ow@olympus.com.
- Quantity
- 1 unit US; 5,286 units OUS
- Distribution
- US Nationwide Distribution.
- Lot, serial or model codes
- Model No. BF-TE2; UDI: 4953170339998; All Serial No.
- 510(k) numbers
- ["K023984"]
- PMA numbers
- not on file
- Product code
- EOQ
- Firm FEI
- 2429304
- Firm city
- Center Valley
- Firm state
- PA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28