Olympus Corporation Of The Americas recalls Olympus EZDilate Endoscopic Balloon Dilator Wired-guided 11

Potential for the inflation chart label affixed to the shaft of the device to be incorrect and indicate a balloon diameter of 18, 19, or 20 mm,

Olympus notified their direct customer on about 08/19/2026 via emailed "URGENT: MEDICAL DEVICE RECALL/PRODUCT REMOVAL" letter. The consignee was instructed to examine inventory for affected units, acknowledge receipt of the recall notification by completing and returning the Reply Form, arrange for the return of affected units for replacement, and if affected units have been further distributed, notify those customers.

• FDA enforcement recordOfficial FDA database entry for Z-3216-2026
• FDA device classification · FGEOfficial FDA classification for this device type
• CFR regulation · 21 CFR 876.5010The federal regulation governing this device
• FDA recall announcementSearch FDA.gov for the official press announcement
• Find Olympus Corporation of the AmericasSearch for the manufacturer's official notice
• News coverageRecent reporting on this recall and manufacturer
• openFDA data recordThe raw JSON record this page is built from

Source: U.S. FDA openFDA device enforcement reports. This summary is informational and may lag or differ from the official record. Always verify against the FDA before acting.