Recall archive / FDA device enforcement
EZDilate Fixed Wire Balloon 8.5-9.5-10.5. Indicated for endoscopic dilation of strictures of the esophagus in adults ... — FDA record Z-0934-2024
Reported ongoing
Status as reported in the agency record. FDA warns that enforcement status may not track the current recall lifecycle; check the current official notice.
Source date Nov 10, 2023. Retrieved Oct 1, 2026. Last updated Oct 1, 2026.
Archive changed Oct 1, 2026. USDA FSIS records are unavailable; check FSIS directly. Source coverage and dates.
What the record says
- Product
- EZDilate Fixed Wire Balloon 8.5-9.5-10.5. Indicated for endoscopic dilation of strictures of the esophagus in adults and adolescents (>12 years). Model: BD-400P-1080
- Reason
- Product balloon issues: inflating, deflating and/or retrieving the devices; reports of bursting and leaking and events involving foreign body in patient and prolonged procedure.
- Classification
- Class II
- Recalling firm
- Olympus Corporation of the Americas
- Quantity
- 1796 units
- Agency-reported status
- Ongoing
- Source record identifier
- Z-0934-2024
What the recall classes mean. Classification is an agency assessment, not individual medical advice.
Lot and product identifiers
| Label field | Details supplied by the agency |
|---|---|
| Lot, code or applicability | UDI-DI: 00821925033177 Lot Numbers: 366479, 384325, 384502 |
Match all identifying details in the current notice. A brand name alone is not enough.
Distribution
Nationwide. Foreign: AU BR BR CA DE HK IN JP SG
States below are derived from the distribution text, including nationwide wording. They are not inferred from the firm's address.
- Alaska
- Alabama
- Arkansas
- Arizona
- California
- Colorado
- Connecticut
- Delaware
- Florida
- Georgia
- Hawaii
- Iowa
- Idaho
- Illinois
- Indiana
- Kansas
- Kentucky
- Louisiana
- Massachusetts
- Maryland
- Maine
- Michigan
- Minnesota
- Missouri
- Mississippi
- Montana
- North Carolina
- North Dakota
- Nebraska
- New Hampshire
- New Jersey
- New Mexico
- Nevada
- New York
- Ohio
- Oklahoma
- Oregon
- Pennsylvania
- Rhode Island
- South Carolina
- South Dakota
- Tennessee
- Texas
- Utah
- Virginia
- Vermont
- Washington
- Wisconsin
- West Virginia
- Wyoming
Dates in the source
- Report date
- Feb 7, 2024
- Recall initiation date
- Nov 10, 2023
- Center classification date
- Jan 31, 2024
FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable.