Olympus Recalls Resection Inner Sheaths Due to Ceramic Tip Breakage
Olympus Corporation of the Americas is recalling over 7,400 resection inner sheaths used in urologic procedures due to reports of the ceramic tip breaking.
What Happened
Olympus Corporation of the Americas has initiated a voluntary recall of its Resection Inner Sheaths following reports of the ceramic tip breaking. This Class II recall was officially classified by the FDA on February 20, 2026, after the firm received complaints regarding the device’s structural integrity during use.
Which Products Are Affected
The recall involves the following medical device used in urologic applications:
- Product Name: Olympus Resection Inner Sheath for 26 Fr. Outer Sheath
- Model Number: A22040T
- UDI: 04042761029360
- Lots: All lots are affected
- Quantity: 7,426 units
- Distribution: Nationwide across the United States
What You Should Do
The firm began notifying customers of the issue via a notification letter on November 11, 2025. Healthcare facilities and providers currently using these devices should follow the specific instructions provided in the firm’s letter. For further information or questions regarding the recall, the recalling firm is Olympus Corporation of the Americas, located at 3500 Corporate Pkwy, Center Valley, PA 18034.
Why This Matters
The breakage of a ceramic tip during a urologic procedure poses a potential risk of injury to the patient or may require additional medical intervention to address the broken fragments.
Source
Information provided by the FDA under recall number Z-1440-2026.
Source: FDA Official Notice