Recall Z-0572-2026 ยท LJE Catheter, Nephrostomy
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 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 b
| Date | Nov 20, 2025 (initiated Oct 17, 2025) |
| Status | Open, Classified |
| Reason | 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 | Process control |
| Action | 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 a |
| Quantity | 60 units |
| Distribution | US Domestic: AK, CA, IA, KY, WA, WI; OUS International: Canada and Germany. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K132383 | GYRUS ACMI NEPHRO - EZDILATE NEPHROSTOMY BALLOON DILATION CATHETER Gyrus Acmi, Inc., Feb 4, 2014 |