FDA Medical Device Recalls (openFDA)
Olympus Corporation of the Americas: EVIS EXERA BF-XT160 Bronchofibervideoscope, Model No. BF-XT160
- Recall number
- Z-2497-2021
- Recalling firm
- Olympus Corporation of the Americas
- Product
- EVIS EXERA BF-XT160 Bronchofibervideoscope, Model No. BF-XT160
- Status
- Terminated
- Initiated
- 2021-08-17
- Posted
- not on file
- Terminated
- 2024-01-12
- Reason
- A gluing step was not performed during the manufacturing of the affected device's insertion tube. There is a potential for the insertion tube to develop a leak, which poses an infection control risk.
- Root cause
- Under Investigation by firm
- Action
- On August 17, 2021, the firm issued Urgent Medical Device Correction letters to affected customers. Customers were informed that Olympus will repair your unit free of charge. An Olympus representative will contact you to make arrangements for return of your affected bronchoscope. If you have further questions about this recall, please contact laura.storms@olympus.com for additional information.
- Quantity
- 27 globally (21 US)
- Distribution
- US Nationwide distribution in the states of CA, IL, MA, MD, MI, NY, OH, OR, and PA.
- Lot, serial or model codes
- 1200148 2500873 2100707 2710983 1500300 1400209 2600505 1300163 1400273 1400248 2700521 2500431 1500310 1200129 2300805 2811029 1500292 2700520 2100743 1500313 2911060
- 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