Olympus Recalls Inner Sheath 21 Fr. Model A2660T Over Ceramic Tip Breakage Concerns
Olympus Corporation of the Americas has issued a voluntary recall for one unit of its Inner Sheath 21 Fr. (Model A2660T) used in urological procedures due to reports of ceramic tip breakage.
What Happened
Olympus Corporation of the Americas has initiated a voluntary, firm-initiated recall of the Olympus Inner Sheath 21 Fr. (Model A2660T). The recall was prompted by complaints that the ceramic tip of the resection sheath can break during use. This device is designed for endoscopic diagnosis and treatment within urological applications.
Which Products Are Affected
The recall specifically targets the following medical device:
- Product Name: Olympus Inner Sheath 21 Fr.
- Model Number: A2660T
- UDI: 04042761004183
- Lots: All Lots
- Quantity: 1 unit
- Distribution: Nationwide distribution within the United States.
- Recall Number: Z-1453-2026
What You Should Do
The firm began notifying affected parties via letter on November 11, 2025. Healthcare providers or facilities identifying this specific model (A2660T) should follow the instructions provided in the firm’s notification. For further information or to coordinate the handling of the affected unit, contact Olympus Corporation of the Americas at 3500 Corporate Pkwy, Center Valley, PA 18034-8229.
Why This Matters
The breakage of a ceramic tip during an endoscopic urological procedure poses a risk of internal injury to the patient or the potential for foreign material to remain within the body.
Source
Information provided by the FDA under Recall Event ID 98288.
Source: FDA Official Notice