Z-0572-2026Class II

Brand Name: EZDilate Nephrostomy Balloon Catheter and Inflation Device Kit Product Name: Olympus...

Name: Z-0572-2026 Brand Name: EZDilate Nephrostomy Balloon Catheter and Inflation Device Kit Product Name: Olympus...
Creator: Olympus Corporation of the Americas
Published: 2025-10-17
License: https://open.fda.gov/license/

OLYMPUS Corporation of the Americas / initiated 2025-10-17 / Open, Classified / root cause: manufacturing process

FDA source

Olympus Corporation of the Americas began a recall of Brand Name: EZDilate Nephrostomy Balloon Catheter and Inflation Device Kit Product Name: Olympus Nephro-EZDilate Nephrostomy Balloon Catheter Model/Catalog... on 2025-10-17. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0572-2026
Classification: Class II
Status: Open, Classified
Initiated: 2025-10-17
Posted: 2025-11-20
Recalling firm: OLYMPUS Corporation of the Americas
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
Product code: LJE Catheter, Nephrostomy
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.
Root cause tag: manufacturing process
FDA 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 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 [email protected].
Quantity in commerce: 60 units
Distribution: US Domestic: AK, CA, IA, KY, WA, WI; OUS International: Canada and Germany.
Product codes and lots: Model: BPCN0815K; UDI: 00821925033016; Lot Number: 25037006;

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0572-2026
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0572-2026	Class II	Ongoing	Voluntary: Firm initiated	2025-11-26	2025-11-20

Product code LJE

K132383UnclassifiedGyrus Acmi Nephro - Ezdilate Nephrostomy Balloon Dilation CatheterGyrus Acmi, Inc. / cleared 2014-02-04

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)