Olympus recalls EZDilate Wire Guided Balloon 13.5-14.5-15.5 for potential bursting and leaking during endoscopic procedures, which may 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 its EZDilate Wire Guided Balloon 13.5-14.5-15.5 for possible bursting and leaking during use. This could lead to foreign body complications in patients during endoscopic procedures.
The balloon may burst or leak during inflation, deflation, or retrieval, potentially causing foreign body issues in patients. This can lead to prolonged procedures and complications during endoscopic treatments.
Adults and adolescents over 12 years old who use this balloon for endoscopic dilation procedures are affected. Medical professionals performing these procedures are most at risk.
Check for model number BD-410X-1555 and lot numbers 372741, 373098, 373607, 378931, 378932, 380775, 380776, 387128, 388778, 388779, 389197, or 389201.
Look for model number BD-410X-1555 and lot numbers listed in the recall notice.
The recall indicates potential bursting and leaking during use, so it is not safe to use without following the recall steps.
The recall does not specify a remedy, so contact Olympus directly for guidance.
Check for model number BD-410X-1555 and lot numbers 372741, 373098, 373607, 378931, 378932, 380775, 380776, 387128, 388778, 388779, 389197, or 389201.
We’ve drafted a message you can send Olympus to request your refund or repair — edit it as you like.
Subject: Recall Z-0942-2024 — Olympus Olympus Hello, I own a Olympus that is covered by recall Z-0942-2024 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.
