FDA Device recall Z-2497-2021
EVIS EXERA BF-XT160 Bronchofibervideoscope, Model No. BF-XT160
- FDA Device
- Class II
- terminated
- Published 2021-09-29
On 2021-09-29 the FDA classified a Class II recall of EVIS EXERA BF-XT160 Bronchofibervideoscope, Model No. BF-XT160 by Olympus, citing 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 inf….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2497-2021 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2021-08-17 |
| Published | 2021-09-29 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Olympus |
| Distribution | US |
Product
EVIS EXERA BF-XT160 Bronchofibervideoscope, Model No. BF-XT160
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.
Identifiers
| code_info | 1200148 2500873 2100707 2710983 1500300 1400209 2600505 1300163 1400273 1400248 2700521 2500431 1500310 1200129 2300805…1200148 2500873 2100707 2710983 1500300 1400209 2600505 1300163 1400273 1400248 2700521 2500431 1500310 1200129 2300805 2811029 1500292 2700520 2100743 1500313 2911060 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2497-2021%22
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