Olympus recalls EZDilate Fixed Wire Balloons 18-19-20 for potential bursting and leaking during endoscopic procedures, which could cause foreign body issues. Affected units include 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 18-19-20 used for esophageal dilation. These devices have reported issues with inflating, deflating, and retrieving, including bursting and leaking, which could lead to foreign body complications in patients.
The balloons can burst or leak during use, which may cause foreign material to remain in the patient's esophagus. This could lead to prolonged procedures, increased risk of injury, and complications during endoscopic dilation.
Adults and adolescents over 12 years old who use these balloons for endoscopic dilation procedures are affected. Medical professionals performing the procedures are at the highest risk due to the potential for serious complications.
Check for model number BD-400P-2080 and lot numbers listed in the recall (e.g., 364645, 365580, 381559). The product is sold for endoscopic dilation of esophageal strictures in adults and adolescents over 12 years.
Identify the model number BD-400P-2080 and lot numbers from the recall list to confirm if your device is affected.
The model number is BD-400P-2080.
Affected lot numbers include 364645, 365580, 365582, 365586, 375543, 375973, 381391, 381558, 381559, 381560, 381892, 381893, 382697, 382698, 383359, 383360, 383361, and additional lots added on December 1, 2023.
The recall record does not specify a remedy.
We’ve drafted a message you can send Olympus to request your refund or repair — edit it as you like.
Subject: Recall Z-0938-2024 — Olympus Olympus Hello, I own a Olympus that is covered by recall Z-0938-2024 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.
