Lower riskMedical device recall · FDA · Published September 13, 2024
Olympus EZDilate Balloon: Mislabeled Size May Cause Prolonged Surgery
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
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Contact the company
📍Recalling firmOlympus Corporation of the Americas3500 Corporate Pkwy · Center Valley, PA 18034-8229
“Olympus EZDilate Balloon: Mislabeled Size May Cause Prolonged Surgery.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/54026-olympus-ezdilate-balloon-mislabeled-size-may-cause-prolonged-surgery. Based on FDA recall #Z-0225-2025 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0225-2025%22&limit=1).
The FDA announced on September 13, 2024, that Olympus Corporation of the Americas is recalling EZDilate Wire Guided Balloons due to mislabeled Glo Cath labels. The hazard involves incorrect balloon diameter markings that may result in prolonged surgery.
How to tell if you have it
Brand: Olympus
Product: EZDilate Wire Guided Balloon
Model/Catalog Number: BD-410X-1055
UDI-DI: 821925033238
Lot Code: 408987
The hazard
The mislabeled Glo Cath Label attached to the device states balloon diameters of 11 mm, 12 mm, and 13 mm, while the actual balloons are 8.5 mm, 9.5 mm, and 10.5 mm. This discrepancy may result in prolonged surgery. All other labeling, including the Shelf Box with Front Box Label, Circular Star Label, and balloon Pouch, is correct.
Context
GovInfoNow's records show Olympus Corporation of the Americas has 133 other recalls on record since August 18, 2017. Recent recalls include an Olympus Tripp-Lite P580-025 DisplayPort Cable recalled on August 27, 2026, for potential video dropout and an Olympus M3 Gold Autoclavable Foroblique Telescope 30: recalled on August 24, 2026, for sterilization parameter discrepancies. Other recent recalls of similar products include a Diversatek Viper 3-Stage Balloon Dilator Recall regarding incorrect part numbers (March 18, 2026), a Diversatek Viper 3-Stage Balloon Dilator Recall regarding an incorrect inflation tag (March 18, 2026), and a Micro Therapeutics Pipeline Flex Embolization Device recall for incorrect labeling (June 8, 2026).
How to tell if you have this one
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.
Brand
Olympus
Category
Medical device
Based on the official FDA remedy
What to do — step by step
Check Product Label
Look for the model number BD-410X-1055 or UDI-DI 821925033238 on the product to confirm it is recalled.
Where it went and when
Where it was distributed
Distributed in 9 states, and outside the U.S.
Listed by the agency
Not listed
FDA distribution: “Worldwide Distribution: US distribution to states of: CA, FL, IL, NJ, NY, PA, TN, VA, WI; and Foreign OUS to countries of: CA, DE, IN, SG, Latin America.” States read from FDA’s own wording; “not listed” means the notice does not name it.
States: California, Florida, Illinois, New Jersey, New York, Pennsylvania, Tennessee, Virginia, Wisconsin.
Recall timeline
FDA published this recall 47 days after the firm started it.
1Firm started the recall
2FDA classified it Class II
3Published in FDA’s Enforcement Report
Dates from the agency record only; steps without a date are left out.
Is there a risk of serious injury from this product?
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.
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.
Official source: FDA Recall #Z-0225-2025 (September 13, 2024) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0225-2025 to see it in context.
Plain-language summary written by qwen3:4b on August 19, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.