Olympus recalls EZDilate Fixed Wire Balloons 11-12-1: reports of bursting, leaking, and foreign body issues during endoscopic procedures. Affected units have specific model and 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 Fixed Wire Balloons 11-12-13 due to reports of bursting, leaking, and foreign body complications during endoscopic procedures. This could lead to serious injury if the balloon fails during use.
The balloon may burst or leak during inflation, deflation, or retrieval, potentially causing foreign body complications or prolonged procedures. This can lead to serious injury if the balloon fails while in the esophagus.
Adults and adolescents over 12 years old who use the EZDilate balloons for esophageal strictures. Patients undergoing endoscopic procedures with these balloons are at risk.
Check for model number BD-400P-1380 and lot numbers 369624 or 377715. The product is intended for endoscopic dilation of esophageal strictures in adults and adolescents over 12.
Identify the model number BD-400P-1380 and lot numbers 369624 or 377715 to confirm if your product is affected.
The product has been reported to burst or leak during use, which can cause serious injury. Do not use until the recall is addressed.
Check the model number and lot numbers to see if your product is affected. If it is, contact Olympus for further instructions.
The recall record does not specify a replacement process. Contact Olympus directly for assistance.
We’ve drafted a message you can send Olympus to request your refund or repair — edit it as you like.
Subject: Recall Z-0935-2024 — Olympus Olympus Hello, I own a Olympus that is covered by recall Z-0935-2024 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.
