Reported Nov 26, 2025 · Ongoing
Brand Name: EZDilate Nephrostomy Balloon Catheter and Inflation Device Kit Product Name: Olympus Nephro-EZDilate…
Olympus Corporation of the Americas
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Olympus Corporation of the Americas · 3500 Corporate Pkwy · Center Valley, PA · 18034-8229
Is this the product you have?
- Brand NameEZDilate Nephrostomy Balloon Catheter
- and Inflation Device Kit Product NameOlympus Nephro-EZDilate Nephrostomy
- Balloon Catheter Model/Catalog NumberBPCN0815K
- Product DescriptionThe 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 codes and dates
- ModelBPCN0815K
- UDI00821925033016
- Lot Number25037006
- Amount recalled
- 60 units
Where it was sold
Why it was recalled
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.
This product could cause temporary or reversible health problems — stop using it.
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