Olympus Resection Sheath, 28 Fr.; Model No. A22043A. Resection sheath for urologic applications.
FDA Recall Z-1445-2026 · Posted 2026-02-20
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Recalling FirmOlympus Corporation of the Americas
Recall StatusOpen, Classified
Product CodeFJL
Date Initiated2025-11-11
Product Quantity118 units
Reason for Recall
Complaints of the ceramic tip of the resection sheath breaking have been received.
Firm Action
An URGENT MEDICAL DEVICE CORRECTIVE ACTION notice was sent to consignees 1/6/2026. Consignees are instructed to ensure all personnel are familiar with the contents of the notification. Users are to adhere to the Inspection and Testing and Caution sections of the IFU for both the resection/inner sheath, as well as the Inspection Before Each Use section in the Resectoscope System Manual. Additional instructions include having an extra resection sheath and inspect during and after procedure for device fragments. Consignees are to retain a copy of the notification with the IFU. Consignees with any questions may contact Cynthia Ow at [email protected] or by phone at 947-999-3203.
Root Cause
Under Investigation by firm
Distribution Pattern
US Nationwide Distribution.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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