Olympus Corporation of the Americas EVIS EXERA BF-XT160 Bronchofibervideoscope, Model No. BF-XT160 Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
EVIS EXERA BF-XT160 Bronchofibervideoscope, Model No. BF-XT160
Brand
Olympus Corporation of the Americas
Lot Codes / Batch Numbers
Not specified in FDA notice. Check official source for details.
Products Sold
1200148 2500873 2100707 2710983 1500300 1400209 2600505 1300163 1400273 1400248 2700521 2500431 1500310 1200129 2300805 2811029 1500292 2700520 2100743 1500313 2911060
Olympus Corporation of the Americas is recalling EVIS EXERA BF-XT160 Bronchofibervideoscope, Model No. BF-XT160 due to 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 devel. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
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.
Recommended Action
Per FDA guidance
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.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026