Drug recall
EVIS EXERA BF-XT160 Bronchofibervideoscope, Model No. BF-XT160
FDA recall event 88560 · Class II · Olympus Corporation of the Americas
Key facts
| Event ID | 88560 |
|---|---|
| Recall numbers | Z-2497-2021 |
| Recalling firm | Olympus Corporation of the Americas |
| Product type | Devices |
| Products | EVIS EXERA BF-XT160 Bronchofibervideoscope, Model No. BF-XT160 |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | 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. |
| Initiation date | Aug 17, 2021 |
| Report date | Sep 29, 2021 |
| Termination date | Jan 12, 2024 |
| City | Center Valley |
| State | PA |
| Country | United States |
| FEI number | 2429304 |
At a glance
- 1–9 Products in this recall
- 10–99 FDA inspections of this firm (FEI)
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA drug and product recalls
FDA enforcement reports list recalls of drugs, biologics, foods and other FDA-regulated products, classified by the potential health hazard.
Source: U.S. Food and Drug Administration (FDA), Enforcement Reports · Source date: