Drug recall
EVIS EXERA III Gastrointestinal Videoscope
FDA recall event 93212 · Class II · Olympus Corporation of the Americas
Key facts
| Event ID | 93212 |
|---|---|
| Recall numbers | Z-0288-2024 |
| Recalling firm | Olympus Corporation of the Americas |
| Product type | Devices |
| Products | EVIS EXERA III Gastrointestinal Videoscope |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | Sterilization failures when devices are sterilized per the Reprocessing Manual due to lack of drying time for the endoscope channel. |
| Initiation date | Oct 2, 2023 |
| Report date | Nov 15, 2023 |
| 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: