Device recall
Z-0638-2022: OER-Elite Endoscope Reprocessor-for use in cleaning and high-level disinfection…
FDA device recall · Class II · Olympus Corporation of the Americas
Key facts
| Recall number (Z-number) | Z-0638-2022 |
|---|---|
| Recall event | 89404 |
| Product | OER-Elite Endoscope Reprocessor-for use in cleaning and high-level disinfection of heat sensitive Olympus flexible endoscopes, their accessories, and endoscope reprocessor accessories |
| Product code | FEB |
| Recalling firm | Olympus Corporation of the Americas |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Dec 26, 2023 |
| 510(k) numbers | K190969, K201920 |
| FEI number | 2429304 |
At a glance
- 1–9 Linked 510(k)s
- 1–9 Products in the same recall event
- 10–99 Recalled products with this product code
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA device recalls (products)
Each recalled device product receives a Z-number. Recall details such as root cause, distribution and firm actions are available in Orca1.
Source: U.S. Food and Drug Administration (FDA), Medical Device Recalls database