—#216521

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

FDA product code: LJE — Catheter, Nephrostomy
Device class: Class U
Medical specialty: Unknown
510(k) numbers: K132383
Affected lot / code info: Model: BPCN0815K; UDI: 00821925033016; Lot Number: 25037006;

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.

Root cause (FDA determination)

Process control

Action the firm took

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.

Recalling firm

Firm: Olympus Corporation of the Americas
Address: 3500 Corporate Pkwy, Center Valley, Pennsylvania 18034-8229

Distribution

Distribution pattern: US Domestic: AK, CA, IA, KY, WA, WI; OUS International: Canada and Germany.

Timeline

Recall initiated: 2025-10-17
Posted by FDA: 2025-11-20
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #216521. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.