Recalls / —

—#218167

Product

Olympus Inner Sheath. Model No. A4741. for endoscopic diagnosis and treatment in gynecological applications.

FDA product code

HIH — Hysteroscope (And Accessories)

Device class

Class 2

Medical specialty

Obstetrics/Gynecology

510(k) numbers

K210651

Affected lot / code info

Model No. A4741; UDI: 04042761006514; All Lots.

Why it was recalled

Complaints of the ceramic tip of the resection sheath breaking have been received.

Root cause (FDA determination)

Under Investigation by firm

Action the firm took

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 Cynthia.Ow@Olympus.com or by phone at 947-999-3203.

Recalling firm

Firm

Olympus Corporation of the Americas

Address

3500 Corporate Pkwy, Center Valley, Pennsylvania 18034-8229

Distribution

Distribution pattern

US Nationwide Distribution.

Timeline

Recall initiated

2025-11-11

Posted by FDA

2026-02-20

Status

—

Source: openFDA Device Recall endpoint. Recall record ID #218167. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.