Drug recall
Brand Name: EZDilate Nephrostomy Balloon Catheter and Inflation Device Kit Product Name: Olympus…
FDA recall event 97757 · Class II · Olympus Corporation of the Americas
Key facts
| Event ID | 97757 |
|---|---|
| Recall numbers | Z-0572-2026 |
| Recalling firm | Olympus Corporation of the Americas |
| Product type | Devices |
| Products | 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… |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | Device kits contained an incorrectly sized 4mm x 4cm urinary tract balloon catheter (BURS0404) instead of the correct 8mm x 15cm nephrostomy tract balloon catheter (BPCN0815). All other components in… |
| Initiation date | Oct 17, 2025 |
| Report date | Nov 26, 2025 |
| City | Center Valley |
| State | PA |
| Country | United States |
| FEI number | 2429304 |
At a glance
- 1–9 Products in this recall
- 10–99 FDA inspections of this firm (FEI)
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA drug and product recalls
FDA enforcement reports list recalls of drugs, biologics, foods and other FDA-regulated products, classified by the potential health hazard.
Source: U.S. Food and Drug Administration (FDA), Enforcement Reports · Source date: