Olympus Recalls Inner Sheaths Due to Risk of Ceramic Tip Breakage
Olympus Corporation of the Americas is recalling 1,141 units of its Inner Sheath (Model WA22017T) used in urological and gynecological procedures due to reports of ceramic tips breaking.
What Happened
Olympus Corporation of the Americas has initiated a voluntary recall of the Olympus Inner Sheath, Long, following reports of the ceramic tip of the resection sheath breaking. The recall was officially classified by the FDA on February 20, 2026, after the firm began notifying customers via letter in late 2025.
Which Products Are Affected
The recall involves medical devices used for urological and gynecological applications. The specific details are as follows:
- Product Name: Olympus Inner Sheath, Long
- Model Number: WA22017T
- UDI: 04042761051521
- Lots Affected: All lots
- Quantity: 1,141 units
- Distribution: Nationwide across the United States
What You Should Do
Olympus Corporation of the Americas initiated the recall through a formal notification letter to affected healthcare facilities. Providers should immediately check their inventory for Model No. WA22017T. Facilities possessing these units should follow the specific instructions provided in the firm’s notification regarding the handling or return of the affected devices. For further inquiries, customers may contact Olympus Corporation of the Americas at their Center Valley, Pennsylvania headquarters.
Why This Matters
The breakage of a ceramic tip during a surgical procedure presents a significant safety risk, as fragments could potentially remain within a patient or cause internal injury, necessitating additional medical intervention.
Source
Information provided by the FDA under Recall Number Z-1451-2026.
Source: FDA Official Notice