Olympus Corporation Of The Americas recalls POWERSEAL 5 MM (in diameter) 23 CM (long)

Potential labeling deficiency in which an outer shelf box is incorrectly labeled as a 37-cm device.

Olympus notified consignees on 08/18/2026 via "URGENT: MEDICAL DEVICE CORRECTION" letter. Consignees were notified of the issue, hazard involved, and that the affected device could still be used. Consignees were instructed to review the recall notification and current inventory for the affected lot number, discard the outer box for any affected units on hand, and attach the recall notification letter to the inner device packaging. Consignees were also instructed to ensure all affected personnel are made aware, to ensure to check the sterile packaging and device labels before use to ensure you are using the correct length for your procedure, notify customers if products were further distributed and complete and return the provided response form.

• FDA enforcement recordOfficial FDA database entry for Z-3035-2026
• FDA 510(k) clearance · K212643The device's official FDA premarket clearance record
• FDA device classification · GEIOfficial FDA classification for this device type
• CFR regulation · 21 CFR 878.4400The 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.