Device recall
Z-0572-2026: Brand Name: EZDilate Nephrostomy Balloon Catheter and Inflation Device Kit…
FDA device recall · Class II · Olympus Corporation of the Americas
Key facts
| Recall number (Z-number) | Z-0572-2026 |
|---|---|
| Recall event | 97757 |
| Product | Brand Name: EZDilate Nephrostomy Balloon Catheter and Inflation Device Kit Product Name: Olympus Nephro-EZDilate Nephrostomy Balloon Catheter Model/Catalog Number: BPCN0815K Product Description: The Nephro-EZDilate nephrostomy balloon catheter is a reinforced catheter attached to a distal dilatation… |
| Product code | LJE |
| Recalling firm | Olympus Corporation of the Americas |
| Recall class | Class II |
| Status | Open, Classified |
| 510(k) numbers | K132383 |
| 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