Brand Name: EZDilate Nephrostomy Balloon Catheter and Inflation… — Class II medical device recall Z-0572-2026
Ongoing recall by Olympus Corporation of the Americas, reported 2025-11-26, distributed in AK, CA, IA, KY, WA, WI. Device kits contained an incorrectly sized 4mm x 4cm urinary tract balloon catheter (BURS0404) instead of the
| Recall number | Z-0572-2026 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Olympus Corporation of the Americas, Center Valley, PA, United States |
| Recall initiated | 2025-10-17 |
| Classified | 2025-11-20 |
| Reported by FDA | 2025-11-26 |
| Distributed | AK, CA, IA, KY, WA, WI |
| Countries outside the US | CA, DE |
| Quantity | 60 units |
| UPC / GTIN / UDI-DI | 00821925033016 |
| Lot numbers | 25037006 |
| Model numbers | BPCN0815K |
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 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 the kits were correctly included and packaged in the kit.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0572-2026. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.