Brand Name: EZDilate Nephrostomy Balloon Catheter and Inflation Device Kit Product Name: Olympus Nephro-EZDilate Nephros
FDA device recall Z-0572-2026 · posted 2025-11-20 · Open, Classified
Recall details
- Recalling firm
- Olympus Corporation of the Americas
- 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.
- Action taken
- 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.
- Root cause
- Process control
- Status
- Open, Classified
- Product code
- LJE
- Quantity affected
- 60 units
- Distribution
- US Domestic: AK, CA, IA, KY, WA, WI; OUS International: Canada and Germany.
- Date initiated
- 2025-10-17
- Date posted
- 2025-11-20
- Location
- Center Valley, PA
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| GYRUS ACMI NEPHRO - EZDILATE NEPHROSTOMY BALLOON DILATION CATHETER (K132383) | Gyrus Acmi, Inc. | 2014-02-04 |