Olympus Recalls Inner Sheaths Used in Gynecological Procedures Due to Breaking Ceramic Tips

What Happened

Olympus Corporation of the Americas has initiated a voluntary, firm-led recall of its Inner Sheath medical devices. The recall was triggered following complaints that the ceramic tip of the resection sheath can break during use. The FDA has classified this as a Class II recall.

Which Products Are Affected

The recall specifically involves the following medical device:

• Product Name: Olympus Inner Sheath
• Model Number: A4741
• UDI: 04042761006514
• Affected Lots: All lots
• Quantity: 91 units
• Distribution: Nationwide across the United States

These devices are designed for endoscopic diagnosis and treatment within gynecological applications.

What You Should Do

Olympus notified affected customers via letter starting in November 2025. Healthcare facilities and providers should immediately check their inventory for Model A4741 Inner Sheaths. If these devices are found, users should follow the instructions provided in the firm’s notification letter. For further information or to coordinate returns, contact Olympus Corporation of the Americas at 3500 Corporate Pkwy, Center Valley, PA 18034-8229.

Why This Matters

A ceramic tip breaking during a gynecological procedure poses a significant risk of internal injury to the patient or the unintended retention of foreign device fragments, which may require additional medical intervention to retrieve.

Source

This information is based on official recall data provided by the FDA under recall number Z-1449-2026.