Olympus recalls Nephro-EZDilate nephrostomy balloon catheter kits with incorrect 4mm x 4cm balloon instead of 8mm x :15cm. This mismatch may cause improper placement or injury during procedures.
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.
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Contact the company
📍Recalling firmOlympus Corporation of the Americas3500 Corporate Pkwy · Center Valley, PA 18034-8229
✎ GovInfoNow plain-language explainer
Olympus is recalling Nephro-EZDilate nephrostomy balloon catheter kits that contain an incorrectly sized 4mm x 4cm balloon instead of the required 8mm x 15cm catheter. Using these kits could lead to improper placement or injury during medical procedures. Read more at govinfonow.com/recall/51048-olympus-nephro-ezdilate-catheter-kit-incorrect-size-risk.
“Olympus Nephro-EZDilate Catheter Kit: Incorrect Size Risk.” GovInfoNow, updated August 18, 2026. https://govinfonow.com/recall/51048-olympus-nephro-ezdilate-catheter-kit-incorrect-size-risk. Based on FDA recall #Z-0572-2026 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0572-2026%22&limit=1).
Olympus Corporation of the Americas voluntarily recalled the Olympus Nephro-EZDilate nephrostomy balloon catheter (Model BPCN0815K) on Oct. 17, 2025, according to the FDA. The hazard involves kits containing an incorrectly sized urinary tract balloon catheter instead of the correct nephrostomy tract balloon catheter.
How to tell if you have it
Brand: Olympus
Product Name: Olympus Nephro-EZDilate
Model/Catalog Number: BPCN0815K
Lot Number: 25037006
Quantity: 60 units
The hazard
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.
Context
GovInfoNow's records show Olympus Corporation of the Americas has 133 other recalls on record since 2017-08-18. Other recent recalls of similar products include BD InLay Optima Ureteral Stent Kit (2025-11-06) and Bard Ureteral Stent Kit Recall (2025-11-06).
How to tell if you have this one
Check for the model number BPCN0815K on the kit. The kit includes a 4mm x 4cm balloon catheter (BURS0404) instead of the correct 8mm x 15cm nephrostomy catheter (BPCN0815).
Brand
Olympus
Category
Medical device
Based on the official FDA remedy
What to do — step by step
Check Kit Model
Verify the model number on the kit; the recalled version has BPCN0815K.
Where it went and when
Where it was distributed
Distributed in 6 states, and outside the U.S.
Listed by the agency
Not listed
FDA distribution: “US Domestic: AK, CA, IA, KY, WA, WI; OUS International: Canada and Germany.” States read from FDA’s own wording; “not listed” means the notice does not name it.
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
Official source: FDA Recall #Z-0572-2026 (October 17, 2025) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0572-2026 to see it in context.
Plain-language summary written by qwen3:4b on August 18, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.