FDA Device recall Z-0572-2026
Brand Name: EZDilate Nephrostomy Balloon Catheter and Inflation Device Kit Product Name: Olympus Nephro-EZDilate Nephrostomy Balloon Cathet…
- FDA Device
- Class II
- ongoing
- Published 2025-11-26
On 2025-11-26 the FDA classified a Class II recall of Brand Name: EZDilate Nephrostomy Balloon Catheter and Inflation Device Kit Product Name: Olympus Nephro-EZDilate Nephrostomy Balloon Cathet… by Olympus, citing 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….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0572-2026 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2025-10-17 |
| Published | 2025-11-26 |
| Last updated | 2026-09-13 11:57 UTC |
| Company | Olympus |
| Distribution | AK, CA, IA, KY, WA, WI |
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 balloon. It has a radiopaque tip and two radiopaque markers positioned on the catheter inside the balloon that define the working length
Reason
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 the kits were correctly included and packaged in the kit.
Identifiers
| code_info | Model: BPCN0815K; UDI: 00821925033016; Lot Number: 25037006; |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:57 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0572-2026%22
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