EZDilate Wire Guided Balloon- Indicated for use in adult and… — Class II medical device recall Z-0225-2025

Ongoing recall by Olympus Corporation of the Americas, reported 2024-10-30, distributed in CA, DE, FL, IL, IN, NJ, NY, PA…. Mislabeled Glo Cath Label (attached to the device) states: 11 mm, 12 mm, 13 mm however the balloon is 8.5mm, 9

Recall number	`Z-0225-2025`
Product type	Medical device
Classification	Class II
Status	Ongoing
Voluntary or mandated	Voluntary
Recalling firm	Olympus Corporation of the Americas, Center Valley, PA, United States
Recall initiated	2024-09-13
Classified	2024-10-24
Reported by FDA	2024-10-30
Distributed	CA, DE, FL, IL, IN, NJ, NY, PA, TN, VA, WI
Quantity	209 units
Reason classes	labeling
UPC / GTIN / UDI-DI	`00821925033238`
Lot numbers	`408987`
Model numbers	`BD-410X-1055`

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

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

Machine access

This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0225-2025. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.

Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.