Z-0225-2025Class II

EZDilate Wire Guided Balloon- Indicated for use in adult and adolescent (> 12 years) populations to...

Name: Z-0225-2025 EZDilate Wire Guided Balloon- Indicated for use in adult and adolescent (> 12 years) populations to...
Creator: Olympus Corporation of the Americas
Published: 2024-09-13
License: https://open.fda.gov/license/

OLYMPUS Corporation of the Americas / initiated 2024-09-13 / Open, Classified / root cause: labeling and UDI

FDA source

Olympus Corporation of the Americas began a recall of EZDilate Wire Guided Balloon- Indicated for use in adult and adolescent (> 12 years) populations to endoscopically dilate strictures of the alimentary tract... on 2024-09-13. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-0225-2025
Classification: Class II
Status: Open, Classified
Initiated: 2024-09-13
Posted: 2024-10-25
Recalling firm: OLYMPUS Corporation of the Americas
Product: 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
Product code: FGE Stents, Drains And Dilators For The Biliary Ducts
Reason for recall: 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
Root cause tag: labeling and UDI
FDA root cause: Under Investigation by firm
Action: 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.
Quantity in commerce: 209 units
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 codes and lots: UDI-DI: 821925033238 Lot: 408987

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0225-2025
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0225-2025	Class II	Ongoing	Voluntary: Firm initiated	2024-10-30	2024-10-24

Product code FGE

K180086Class IIGyrus ACMI – EZDilate 3-Stage Balloon Dilatation CatheterGyrus Acmi, Inc. / cleared 2018-03-08

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)