Olympus Corporation Recalls Resection Sheaths Due to Risk of Ceramic Tip Breaking
Olympus Corporation of the Americas has voluntarily recalled 2,626 resection sheaths used in urologic procedures because the ceramic tips may break during use.
What Happened
Olympus Corporation of the Americas has initiated a voluntary recall of its resection sheaths following reports that the ceramic tip of the device can break. The recall was classified by the FDA as a Class II event on February 20, 2026.
Which Products Are Affected
The recall involves the following medical device used for urologic applications:
- Product Name: Olympus Resection Sheath, 24 Fr., with Deflecting Obturator
- Model Number: A22041T
- UDI: 04042761020978
- Affected Units: 2,626 units
- Lot Information: All lots are included in this recall.
- Recall Number: Z-1442-2026
These products were distributed nationwide throughout the United States.
What You Should Do
Olympus Corporation of the Americas began notifying customers of the issue via a firm-initiated letter on November 11, 2025. Healthcare providers and facilities possessing these devices should follow the instructions outlined in the notification letter regarding the affected units. For further information, providers should contact Olympus Corporation of the Americas at their Center Valley, PA headquarters.
Why This Matters
The breakage of a ceramic tip during a surgical procedure poses a risk of injury to the patient and may necessitate additional medical intervention to retrieve fragments from the body.
Source
Information provided by the FDA. Recall Event ID: 98288.
Source: FDA Official Notice