Device recall
Z-0458-2021: Olympus Leak Test Adapter used with Acu-sInQ Complete Endoscope Cleaning Aid…
FDA device recall · Class III · Steris Corporation
Key facts
| Recall number (Z-number) | Z-0458-2021 |
|---|---|
| Recall event | 86596 |
| Product | Olympus Leak Test Adapter used with Acu-sInQ Complete Endoscope Cleaning Aid Systems-intended to assist manual flexible endoscope cleaning Part number: 0600818OKN |
| Product code | FEB |
| Recalling firm | Steris Corporation |
| Recall class | Class III |
| Status | Terminated |
| Termination date | Jul 14, 2021 |
| 510(k) numbers | K181865 |
| FEI number | 1527821 |
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