Recall archive / FDA device enforcement
Brand Name: EZDilate Nephrostomy Balloon Catheter and Inflation Device Kit Product Name: Olympus Nephro-EZDilate Neph... — FDA record Z-0572-2026
Reported ongoing
Status as reported in the agency record. FDA warns that enforcement status may not track the current recall lifecycle; check the current official notice.
Source date Oct 17, 2025. Retrieved Oct 1, 2026. Last updated Oct 1, 2026.
Archive changed Oct 1, 2026. USDA FSIS records are unavailable; check FSIS directly. Source coverage and dates.
What the record says
- 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.
- Classification
- Class II
- Recalling firm
- Olympus Corporation of the Americas
- Quantity
- 60 units
- Agency-reported status
- Ongoing
- Source record identifier
- Z-0572-2026
What the recall classes mean. Classification is an agency assessment, not individual medical advice.
Lot and product identifiers
| Label field | Details supplied by the agency |
|---|---|
| Lot, code or applicability | Model: BPCN0815K; UDI: 00821925033016; Lot Number: 25037006; |
Match all identifying details in the current notice. A brand name alone is not enough.
Distribution
US Domestic: AK, CA, IA, KY, WA, WI; OUS International: Canada and Germany.
States below are derived from the distribution text, including nationwide wording. They are not inferred from the firm's address.
Dates in the source
- Report date
- Nov 26, 2025
- Recall initiation date
- Oct 17, 2025
- Center classification date
- Nov 20, 2025
FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable.