FDAHealthOctober 17, 2025
Olympus Corporation of the Americas — Brand Name: EZDilate Nephrostomy Balloon Catheter and Inflation Device Kit Product Name: Olympus Nephro-EZDilate Nephrostomy Balloon Catheter Model/Catalog Numb
⚠️ 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.
Is this relevant to me?
- Geography
- US, AK, CA, IA, KY, WA, WI
- Source agency
- FDA
- Category
- Health
- Published
- October 17, 2025
US Domestic: AK, CA, IA, KY, WA, WI; OUS International: Canada and Germany.
What's affected?
- 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
- Lot code
- 25037006
Additional details
Model: BPCN0815K; UDI: 00821925033016; Lot Number: 25037006;
What should I do?
Recommended action
Class II recall. Voluntary: Firm initiated Quantity affected: 60 units.
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