Olympus Issues Recall for Resection Sheaths Due to Risk of Ceramic Tip Breakage

What Happened

Olympus Corporation of the Americas has initiated a voluntary, firm-initiated recall of its Resection Sheath devices. The recall was triggered following multiple complaints that the ceramic tip of the resection sheath can break during use. This device is specifically designed for endoscopic diagnosis and treatment within urological applications.

Which Products Are Affected

The recall involves the following medical device:

• Product Name: Olympus Resection Sheath
• Model Number: A2666T
• UDI: 04042761004251
• Lot Information: All lots are included in this recall.
• Recall Number: Z-1457-2026

The products were distributed nationwide across the United States. While the source data lists 0 units, the recall applies to all lots of the specified model number currently in circulation.

What You Should Do

Olympus notified affected customers via an initial firm notification letter sent on November 11, 2025. Healthcare facilities and providers should immediately identify if they have the affected Model A2666T Resection Sheaths in their inventory. Users should follow the specific instructions provided in the Olympus notification letter regarding the handling and return of these devices. For further inquiries, customers may contact Olympus Corporation of the Americas at their headquarters in Center Valley, Pennsylvania.

Why This Matters

The breakage of a ceramic tip during an endoscopic urological procedure poses a risk to patient safety, as fragments could potentially remain in the body or necessitate additional medical intervention to retrieve. The FDA has classified this as a Class II recall, indicating a situation where use of the product may cause temporary or medically reversible adverse health consequences.

Source

Information provided by the FDA under recall event ID 98288.