EZDilate Nephrostomy Catheter (Olympus) – Incorrect Balloon Size (2025)
Hazard assessment based on recall description.
This AI-generated summary is provided for general informational purposes only and is derived from publicly available recall notices. It supplements but does not replace official agency classifications or safety instructions.
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
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
Brand
Olympus Corporation of the Americas
Lot Codes / Batch Numbers
Model: BPCN0815K, UDI: 00821925033016, Lot Number: 25037006
Products Sold
Model: BPCN0815K; UDI: 00821925033016; Lot Number: 25037006;
Olympus Corporation of the Americas is recalling Brand Name: EZDilate Nephrostomy Balloon Catheter and Inflation Device Kit Product Name: Olympus Nep due to Device kits contained an incorrectly sized 4mm x 4cm urinary tract balloon catheter (BURS0404) instead of the correct 8mm x 15cm nephrostomy tract bal. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
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.
Recommended Action
Per FDA guidance
On October 17, 2025, "URGENT: MEDICAL DEVICE REMOVAL" letters were sent to customers. Actions required: 1. 1. Examine your inventory and quarantine any affected devices. 2. Cease usage of the product with immediate effect. 3. Return any remaining affected product, please contact Customer Service at 1-800-848-9024, option 2, to obtain a Return Material Authorization. Olympus will issue a credit to your facility upon return of your affected product. 4. Please forward this notice to other users who may have the affected products if you have further distributed it. Olympus requests you to report any complaints to our Technical Assistance Center (TAC) at 1- 800-848-9024, option 1, and the FDA If you require additional information, please do not hesitate to contact directly by phone at (647) 999-3203 or by e-mail Cynthia.Ow@Olympus.com.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticeDistribution
As reported by FDA
AK, CA, IA, KY, WA, WI
Page updated: Jan 10, 2026