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U.S. Department of Health and Human Services

Class 2 Device Recall EZDilate Nephrostomy Balloon Catheter and Inflation Device Kit

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 Class 2 Device Recall EZDilate Nephrostomy Balloon Catheter and Inflation Device Kitsee related information
Date Initiated by FirmOctober 17, 2025
Date PostedNovember 20, 2025
Recall Status1 Open3, Classified
Recall NumberZ-0572-2026
Recall Event ID 97757
510(K)NumberK132383 
Product Classification Catheter, nephrostomy - Product Code LJE
ProductBrand 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
Code Information Model: BPCN0815K; UDI: 00821925033016; Lot Number: 25037006;
FEI Number 2429304
Recalling Firm/
Manufacturer		 Olympus Corporation of the Americas
3500 Corporate Pkwy
Center Valley PA 18034-8229
For Additional Information ContactCynthia Ow
484-896-5000
Manufacturer 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.
FDA Determined
Cause 2		Process control
ActionOn 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.
Quantity in Commerce60 units
DistributionUS Domestic: AK, CA, IA, KY, WA, WI; OUS International: Canada and Germany.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database510(K)s with Product Code = LJE
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