Olympus recalls EZDilate Wire Guided Balloons for adults and teens over 12 due to mislabeled sizes (11mm/12mm/13mm listed but actual 8.5mm/9.5mm/10.5mm) that may lead to longer surgery times.
Mislabeled Glo Cath Label (attached to the device) states: 11 mm, 12 mm, 13 mm however the balloon is 8.5mm, 9.5mm and 10.5 mm and may result in prolonged surgery. All other labeling is correct for the balloon, including the Shelf Box with Front Box Label and Circular Star Label and the balloon Pouch
Olympus is recalling EZDilate Wire Guided Balloons for adults and teens over 12 because the product's labels incorrectly state the balloon size. This mismatch could cause surgery to last longer than necessary, potentially increasing risks for patients.
The balloon's actual size (8.5mm, 9.5mm, 10.5mm) differs from what's labeled (11mm, 12mm, 13mm). This mismatch may cause the balloon to be too small for the intended procedure, leading to prolonged surgery times and increased patient risk.
Adults and adolescents over 12 years who use the EZDilate Wire Guided Balloon for endoscopic procedures. Patients at highest risk are those undergoing surgery where balloon size accuracy is critical.
Check for the model number BD-410X-1055 or UDI-DI 821925033238 on the product. The product was sold with a label stating 11mm, 12mm, or 13mm but the actual balloon size is 8.5mm, 9.5mm, or 10.5mm.
Look for the model number BD-410X-1055 or UDI-DI 821925033238 on the product to confirm it is recalled.
The balloon's actual size (8.5mm, 9.5mm, 10.5mm) differs from what's labeled (11mm, 12mm, 13mm), which may cause surgery to last longer than necessary.
Check the product label for the model number BD-410X-1055 or UDI-DI 821925033238. If it matches, contact Olympus for further instructions.
The recall is for potential prolonged surgery times, not immediate serious injury. The hazard level is low risk as the product is intended for medical use with proper labeling.
We’ve drafted a message you can send Olympus to request your refund or repair — edit it as you like.
Subject: Recall Z-0225-2025 — Olympus Olympus Hello, I own a Olympus that is covered by recall Z-0225-2025 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.
