Olympus recalls EZDilate Wire Guided Balloon 11-12-13 due to 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 its EZDilate Wire Guided Balloon 11-12-13 for endoscopic procedures because reports show the balloon can burst, leak, or cause foreign body issues in patients. This poses a risk of serious injury during medical use.
The balloon may burst, leak, or cause foreign body complications during endoscopic procedures. These issues can lead to serious injuries in patients, including prolonged procedures and complications from the balloon material.
Adults and adolescents over 12 years old who use this balloon for endoscopic dilation procedures are affected. Medical professionals performing these procedures with the recalled model are most at risk.
Check for model number BD-410X-1355 and lot numbers 369715, 370108, 370270, 370496, 377814, 378933, 379534, 386461, 386462, or 388459. The product is intended for endoscopic dilation of strictures in the alimentary tract.
Identify the model number BD-410X-1355 and lot numbers listed in the recall notice.
The product has been recalled due to reports of bursting, leaking, and foreign body issues during procedures. It is not safe to use without following the recall steps.
Check the model number and lot numbers listed in the recall notice. If you have the affected model, contact Olympus for further instructions.
Look for model number BD-410X-1355 and lot numbers 369715, 370108, 370270, 370496, 377814, 378933, 379534, 386461, 386462, or 388459.
We’ve drafted a message you can send Olympus to request your refund or repair — edit it as you like.
Subject: Recall Z-0941-2024 — Olympus Olympus Hello, I own a Olympus that is covered by recall Z-0941-2024 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.
