Device recall
Z-1071-2025: Olympus Single Use Guide Sheath Kits with the following product descriptions and…
FDA device recall · Class I · Olympus Corporation of the Americas
Key facts
| Recall number (Z-number) | Z-1071-2025 |
|---|---|
| Recall event | 96087 |
| Product | Olympus Single Use Guide Sheath Kits with the following product descriptions and model numbers: 1. Single Use Guide Sheath Kit K-201 2.0MM Channel Set: Guide Sheath, Biopsy Forceps, Cytology Brush; Model Number: K-201 2. Single Use Guide Sheath Kit K-202 2.0MM Channel Set: Guide Sheath, Biopsy… |
| Product code | EOQ |
| Recalling firm | Olympus Corporation of the Americas |
| Recall class | Class I |
| Status | Open, Classified |
| 510(k) numbers | K060243 |
| FEI number | 2429304 |
At a glance
- 1–9 Linked 510(k)s
- 1–9 Products in the same recall event
- 100–999 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