Olympus recalls EZDilate Fixed Wire Balloon 6-7-8 for potential bursting and leaking during endoscopic procedures, which could cause foreign body issues in patients.
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.
Olymp: Olympus is recalling its EZDilate Fixed Wire Balloon 6-7-8 for endoscopic dilation procedures due to reports of bursting, leaking, and foreign body complications in patients. 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 or serious medical issues if the device fails during use.
Adults and adolescents over 12 years old who use this balloon for esophageal strictures. Patients undergoing endoscopic dilation procedures are most at risk.
Check for model number BD-400P-0880 or UDI-DI 00821925033160 on the device. The product was sold with lot number 380777.
Look for model number BD-400P-0880 or UDI-DI 00821925033160 on the device.
Reach out to Olympus Corporation of the Americas for further assistance if you have the recalled model.
The product has been recalled due to reports of bursting and leaking, which could cause foreign body complications. It is not recommended for use until the recall is resolved.
Check the model number and UDI-DI on the device. Contact Olympus Corporation of the Americas for further instructions.
The recalled product has model number BD-400P-0880 and UDI-DI 00821925033160 with lot number 380777.
We’ve drafted a message you can send Olympus to request your refund or repair — edit it as you like.
Subject: Recall Z-0933-2024 — Olympus Olympus Hello, I own a Olympus that is covered by recall Z-0933-2024 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.
