Olympus recalls EZDilate Fixed Wire Balloons 13.5-15.5 for potential bursting and leaking during endoscopic procedures, risking foreign body complications. 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 certain EZDilate Fixed Wire Balloons used for esophageal dilation due to reports of bursting, leaking, and foreign body complications during procedures. This could lead to serious medical issues if the device fails during use.
The balloon may burst or leak during inflation, deflation, or retrieval, potentially causing foreign body complications in the patient. This could lead to prolonged procedures and serious medical issues if the device fails during use.
Adults and adolescents over 12 years old who use the EZDilate balloon for esophageal strictures. Medical professionals performing endoscopic procedures with the recalled model are most at risk.
Check for model number BD-400P-1580 and lot numbers 360910, 360911, 364014, 364158, 364338, 367646, 367647, 367648, 383363, 383846, 383847, 384058. The product is sold for endoscopic dilation of esophageal strictures in adults and adolescents over 12.
Identify the model number BD-400P-1580 and lot numbers listed above to confirm if your device is affected.
The recall indicates potential risks of bursting and leaking during use, 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 on next steps.
Check for model number BD-400P-1580 and lot numbers 360910, 360911, 364014, 364158, 364338, 367646, 367647, 367648, 383363, 383846, 383847, 384058.
We’ve drafted a message you can send Olympus to request your refund or repair — edit it as you like.
Subject: Recall Z-0936-2024 — Olympus Olympus Hello, I own a Olympus that is covered by recall Z-0936-2024 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.
