Olympus recalls EZDilate Fixed Wire Balloons (model BD-400P-1080) for possible bursting and leaking during endoscopic procedures, which could cause serious injury. Affected units include 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 certain EZDilate Fixed Wire Balloons for possible bursting and leaking during endoscopic procedures. This could lead to serious injury or complications for patients. The recall affects specific model numbers and lot numbers.
The balloon may burst or leak during inflation, deflation, or retrieval, potentially causing foreign body injuries or prolonged procedures. This can lead to serious complications like tissue damage or infection.
Adults and adolescents over 12 years old who use the EZDilate balloon for esophageal strictures. Medical professionals performing endoscopic procedures are most at risk.
Check for model BD-400P-1080 and lot numbers 366479, 384325, or 384502. The product is used for endoscopic dilation of esophageal strictures in adults and adolescents over 12.
Identify the model number (BD-400P-1080) and lot numbers (366479, 384325, 384502) to confirm if your device is affected.
The recall indicates potential risks like bursting and leaking, so it is not recommended for use until the remedy is applied.
The recall does not specify a remedy, so contact Olympus directly for guidance.
Check for model BD-400P-1080 and lot numbers 366479, 384325, or 384502.
We’ve drafted a message you can send Olympus to request your refund or repair — edit it as you like.
Subject: Recall Z-0934-2024 — Olympus Olympus Hello, I own a Olympus that is covered by recall Z-0934-2024 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.
Experiences, tips, and questions from readers. Every comment is reviewed before it appears.
No comments yet — be the first to share your experience.
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.
