Device recall
Z-1353-2026: Olympus High Flow Insufflation Unit. Model/ Number: UHI-2. Used for insufflation…
FDA device recall · Class I · Olympus Corporation of the Americas
Key facts
| Recall number (Z-number) | Z-1353-2026 |
|---|---|
| Recall event | 98243 |
| Product | Olympus High Flow Insufflation Unit. Model/ Number: UHI-2. Used for insufflation of the abdominal cavity, and automatic suction and smoke evacuation to facilitate laparoscopic observation and treatment within the abdominal cavity. |
| Product code | HIF |
| Recalling firm | Olympus Corporation of the Americas |
| Recall class | Class I |
| Status | Open, Classified |
| 510(k) numbers | K953162 |
| 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