FDA Medical Device Recalls (openFDA)
Olympus Corporation of the Americas: Olympus Bronchovideoscope, Models BF-3C40 & BF-N20.
- Recall number
- Z-2502-2023
- Recalling firm
- Olympus Corporation of the Americas
- Product
- Olympus Bronchovideoscope, Models BF-3C40 & BF-N20.
- Status
- Open, Classified
- Initiated
- 2023-07-27
- Posted
- 2023-08-31
- Terminated
- not on file
- Reason
- Complaint of endoscope model becoming lodged in the endotracheal tube connector due to diameter being too large.
- Root cause
- Labeling Change Control
- Action
- Consignees were mailed an Urgent Medical Device Correction notification dated 7/27/2023 via UPS. The notification asks that consignees inspect their inventory for recalled devices and check clinical areas to see if any remain in use. Consignees are to ensure that all personnel, including clinical staff, are completely knowledgeable of this recall notification and addendum, which instructs users to slide the endotracheal tube along the entire length of the tracheal intubation scope insertion section to confirm compatibility before using on a patient. Consignees are asked to complete and return the provided response form to Sedgwick via email at Olympus7498@sedgwick.com or by fax at 866-552-4917. Any questions about the acknowledgement form may be directed by phone to 866-737-4762. If product has been further distributed, please forward the notification to those secondary consignees and maintain records of your documentation process. Consignees are to report any complaints to Olympus Technical Assistance Center at 1-800-848-9024 (Option 1) and FDA Medwatch. Any further questions are to be directed to Tara Safi by email at Tara.Safi@Olympus.com.
- Quantity
- 881 units
- Distribution
- US Nationwide distribution.
- Lot, serial or model codes
- UDI-DI: 04953170308130, 04953170339219, 04953170051142, & 04953170442667; All Serial Numbers.
- 510(k) numbers
- ["K910423"]
- 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