Olympus recalls EZDilate Wire Guided Balloons 18-19-20 due to reports of bursting, leaking, and foreign body issues during endoscopic procedures. Affected units have specific lot numbers and model identifiers.
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 EZDilate Wire Guided Balloons 18-19-20 that are used for endoscopic dilation. These balloons have been reported to burst, leak, or cause foreign body issues in patients during procedures, which could lead to serious complications.
The balloons can burst or leak during use, potentially causing foreign bodies to remain in the patient's body. This may lead to complications such as prolonged procedures, tissue damage, or other serious health issues.
Adults and adolescents over 12 years old who use the EZDilate balloons for endoscopic procedures are affected. Patients undergoing dilation treatments with the recalled balloons are at the highest risk.
Check for model number BD-410X-2055 and lot numbers including 366881, 367026, 367030, 369509, 370718, 371173, 372147, 374100, 374101, 374810, 386463, 386841, 386842, 387130, 387424.
Verify the model number (BD-410X-2055) and lot numbers listed in the recall notice.
The model number is BD-410X-2055.
Affected lot numbers include 366881, 367026, 367030, 369509, 370718, 371173, 372147, 374100, 374101, 374810, 386463, 386841, 386842, 387130, 387424.
The balloons have been reported to burst, leak, or cause foreign body issues during procedures, which could lead to serious complications.
We’ve drafted a message you can send Olympus to request your refund or repair — edit it as you like.
Subject: Recall Z-0944-2024 — Olympus Olympus Hello, I own a Olympus that is covered by recall Z-0944-2024 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.
