Olympus recalls EZDilate Wire Guided Balloon 6-7-8 for possible bursting and leaking during endoscopic procedures, affecting specific lot numbers.
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 Balloon 6-7-8 devices for possible bursting and leaking during endoscopic procedures. This could lead to foreign body complications in patients and prolonged procedures.
The balloon may burst or leak during inflation, deflation, or retrieval, potentially causing foreign body complications in patients. This can lead to prolonged procedures and increased risk of injury.
Adults and adolescents over 12 years old who use the EZDilate Wire Guided Balloon 6-7-8 for endoscopic dilation. Medical professionals performing procedures with these devices are at highest risk.
Check for model number BD-410X-0855 and lot numbers 373808, 374005, 379746, 379747, 379835, 379836, or 381157. These devices were sold for endoscopic dilation in adults and adolescents over 12 years.
Verify the model number is BD-410X-0855 and lot numbers match the listed numbers.
Reach out to Olympus Corporation of the Americas for further guidance on the recall.
The recall indicates potential risks of bursting and leaking during use, so it is not recommended for current use without manufacturer guidance.
Check the model number and lot numbers to confirm if your device is affected; contact Olympus for specific instructions.
The recall record does not specify a replacement option; contact Olympus for further assistance.
We’ve drafted a message you can send Olympus to request your refund or repair — edit it as you like.
Subject: Recall Z-0939-2024 — Olympus Olympus Hello, I own a Olympus that is covered by recall Z-0939-2024 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.
