Olympus Recalls Resection Sheaths Over Risk of Ceramic Tip Breakage
Olympus Corporation of the Americas has issued a voluntary recall for 899 units of its 8 mm Resection Sheaths due to reports of ceramic tips breaking during gynecological procedures.
What Happened
Olympus Corporation of the Americas has initiated a voluntary, firm-initiated recall of its 8 mm Resection Sheaths. The recall was prompted by complaints regarding the ceramic tip of the resection sheath breaking during use. This device is specifically designed for gynecological applications.
Which Products Are Affected
The recall involves the following medical device:
- Product Name: Olympus Resection Sheath, 8 mm
- Model Number: A42011A
- UDI: 04042761023658
- Affected Lots: All lots are included in this recall.
- Quantity: 899 units
- Distribution: The product was distributed nationwide across the United States.
What You Should Do
Olympus notified affected customers via a formal letter starting in November 2025. Healthcare facilities and providers in possession of these devices should follow the instructions provided in the firm’s notification. For additional information or questions regarding returns, consumers may contact Olympus Corporation of the Americas at their headquarters located at 3500 Corporate Pkwy, Center Valley, PA 18034-8229.
Why This Matters
The breakage of a ceramic tip during a surgical procedure poses a risk of internal injury to the patient and may necessitate additional medical intervention to retrieve fragments from the body.
Source
Information provided by the FDA under Recall Number Z-1448-2026.
Source: FDA Official Notice