EZDilate recallZ-0225-2025 · Olympus Corporation of the Americas · initiated Sep 13, 2024
Open, Classified
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Olympus Corporation of the Americas or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
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
FDA root cause category: Under Investigation by firm
What the company is doing
Olympus issued Urgent Medical Device Removal letter issued 9/13/24 to Endoscopy Department, Risk Management Department. Letter states reason for recall, health risk and action to take: 2. Examine your inventory and identify the above-listed device with the affected batch number. 3. Please contact Customer Service at 1-800-848-9024, option 2, to obtain a Return Material Authorization. Olympus will arrange for the return of your device to Olympus. When it is received, you will receive a credit for your affected device(s). 4. If you have further distributed this product, identify your customers, and forward them this notification. 5. Olympus requests that you acknowledge receipt of this letter. Access the Olympus recall portal to indicate that you have received this notification. a) Go to https://olympusamerica.com/recall b) Enter the recall number "0453 c) Complete the form as instructed. Olympus requests that you report any complaints, including any incorrect labeling, to the Olympus Technical Assistance Center (TAC) at 1-800-848-9024 (option 1). If you require additional information, please do not hesitate to contact me by e-mail at [email protected] or by phone at (647) 999-3203.
Recall details
- Recall number
- Z-0225-2025
- Status
- Open, Classified
- Initiated by the company
- Sep 13, 2024
- Posted by the FDA
- Oct 25, 2024
- Recalling firm
- Olympus Corporation of the Americas
- Quantity
- 209 units
- Product code
- FGE
- FDA submissions
- K180086
- 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.
Product description
EZDilate Wire Guided Balloon- Indicated for use in adult and adolescent (> 12 years) populations to endoscopically dilate strictures of the alimentary tract. It is also indicated in adults for endoscopic dilatation of the Sphincter of Oddi with or without prior sphincterotomy. Model/Catalog Number: BD-410X-1055
Code information (models, lots, serial numbers)
UDI-DI: 821925033238 Lot: 408987
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- EZDilate BD-410X-1055Gyrus ACMI, LLC · Dilator, esophageal2 recalls0 reports
Product lines
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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