Olympus recalls EZDilate Fixed Wire Balloons 16-17-18 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 recalls certain EZDilate Fixed Wire Balloons (16-17-18) used for esophageal dilation due to reports of bursting, leaking, and foreign body complications. This could lead to serious medical issues during procedures.
The balloons may burst or leak during inflation, deflation, or retrieval, potentially causing foreign body complications in the patient. This can lead to prolonged procedures and serious medical issues if not addressed.
Healthcare professionals using the EZDilate balloons for endoscopic procedures on adults and adolescents over 12 years old. Patients undergoing dilation procedures with these specific models are at risk.
Check for model number BD-400P-1880 and lot numbers including 365375, 365823, 365824, 365825, 369028, 382273, 382350, 382351, 383160 (added 12/1/23: 376575, 376888, 376914). These balloons are used for endoscopic dilation of esophageal strictures in adults and adolescents over 12.
Identify the model number BD-400P-1880 and lot numbers listed in the recall notice to confirm if your device is affected.
The model number is BD-400P-1880.
Affected lot numbers include 365375, 365823, 365824, 365825, 369028, 382273, 382350, 382351, 383160 (added 12/1/23: 376575, 376888, 376914).
Yes, reports indicate bursting, leaking, and foreign body complications during procedures, which could lead to serious medical issues.
We’ve drafted a message you can send Olympus to request your refund or repair — edit it as you like.
Subject: Recall Z-0937-2024 — Olympus Olympus Hello, I own a Olympus that is covered by recall Z-0937-2024 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.
