Olympus Issues Recall for Resection Sheath Due to Risk of Ceramic Tip Breakage
Olympus Corporation of the Americas has initiated a voluntary recall of a resection sheath model used in urologic procedures after reports of the ceramic tip breaking.
What Happened
Olympus Corporation of the Americas has initiated a voluntary, firm-led recall of its resection sheath designed for urologic applications. The recall was prompted by complaints regarding the ceramic tip of the device breaking 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 Resection Sheath
- Model Number: A2666
- UDI: 04042761004244
- Lots: All lots are affected
- Quantity: 1 unit identified in this action
- Distribution: Nationwide within the United States
What You Should Do
Healthcare facilities and providers should immediately check their inventory for the Olympus Resection Sheath, Model No. A2666. The firm initiated notification to customers via letter on November 11, 2025. Facilities possessing the affected unit should follow the instructions provided in the firm’s notification or contact Olympus Corporation of the Americas at their Center Valley, PA headquarters for guidance on returning or replacing the device.
Why This Matters
A breakage of the ceramic tip during a urologic procedure poses a risk of injury to the patient or the introduction of foreign material into the surgical site, which may necessitate further medical intervention.
Source
Information provided by the FDA. Recall Number: Z-1452-2026.
Source: FDA Official Notice