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.
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.
The kit contains a 4mm x 4cm balloon instead of the correct 8mm x 15cm catheter. This size mismatch could cause improper placement in the urinary tract, potentially leading to injury or complications during procedures.
Patients undergoing nephrostomy procedures who use the recalled kits are affected. Medical professionals using the kits for procedures are at risk if they use the incorrect model.
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).
Verify the model number on the kit; the recalled version has BPCN0815K.
The correct size is 8mm x 15cm (BPCN0815). The recalled kit has a 4mm x 4cm catheter (BURS0404).
Look for the model number BPCN0815K on the kit. The recalled kit contains a 4mm x 4cm balloon catheter instead of the correct 8mm x 15cm catheter.
The recall record does not specify a remedy, so contact Olympus directly for guidance.
We’ve drafted a message you can send Olympus to request your refund or repair — edit it as you like.
Subject: Recall Z-0572-2026 — Olympus Olympus Hello, I own a Olympus that is covered by recall Z-0572-2026 from Olympus. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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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.
