EZDilate recallZ-0572-2026 · Olympus Corporation of the Americas · initiated Oct 17, 2025
Open, Classified
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Olympus Corporation of the Americas or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
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.
FDA root cause category: Process control
What the company is doing
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].
Recall details
- Recall number
- Z-0572-2026
- Status
- Open, Classified
- Initiated by the company
- Oct 17, 2025
- Posted by the FDA
- Nov 20, 2025
- Recalling firm
- Olympus Corporation of the Americas
- Quantity
- 60 units
- Product code
- LJE
- FDA submissions
- K132383
- Distribution
- US Domestic: AK, CA, IA, KY, WA, WI; OUS International: Canada and Germany.
Product description
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
Code information (models, lots, serial numbers)
Model: BPCN0815K; UDI: 00821925033016; Lot Number: 25037006;
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- EZDilate BPCN0815KGyrus ACMI, LLC · CATHETER, NEPHROSTOMY1 recall1 report
Product lines
Other devices under the same FDA submission
2 devices cleared under K132383 are not named by identifier in this recall. One submission often covers many models, so they may or may not be affected.
- EZDilate BPCN1015Gyrus ACMI, LLC · CATHETER, NEPHROSTOMY2 reports
- EZDilate BPCN1015KGyrus ACMI, LLC · CATHETER, NEPHROSTOMY1 report
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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