Olympus recalls EZDilate Wire Guided Balloons 16-17-18 for potential bursting and leaking during endoscopic procedures, which could cause foreign body issues in patients.
Product balloon issues: inflating, deflating and/or retrieving the devices; reports of bursting and leaking and events involving foreign body in patient and prolonged procedure.
Olympus is recalling certain EZDilate Wire Guided Balloons (16-17-18) used in endoscopic procedures due to reports of bursting, leaking, and foreign body complications. This could lead to serious patient risks during dilation treatments.
The balloons can burst or leak during inflation, deflation, or retrieval, potentially causing foreign body issues in the patient's alimentary tract. This may lead to prolonged procedures and complications during endoscopic dilation.
Adults and adolescents over 12 years old who use these balloons for endoscopic dilation procedures. Patients undergoing these treatments are at risk if they have the recalled model.
Check for model number BD-410X-1855 and lot numbers 360769, 360770, 368258, 368259, 368844, 369417, 385724, 387425, 387426, 387794, or 387795. These balloons are used for endoscopic dilation in adults and adolescents over 12.
Verify the model number BD-410X-1855 and lot numbers listed in the recall notice.
The recall is due to reports of bursting, leaking, and foreign body issues during endoscopic procedures, which could cause complications in patients.
The official recall notice does not specify a remedy, so check with Olympus for further instructions.
Yes, the balloons are indicated for use in adults and adolescents over 12 years old.
We’ve drafted a message you can send Olympus to request your refund or repair — edit it as you like.
Subject: Recall Z-0943-2024 — Olympus Olympus Hello, I own a Olympus that is covered by recall Z-0943-2024 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.
