Olympus Corporation of the Americas Recalls Inner Sheath Devices Due to Breaking Ceramic Tips
Olympus Corporation of the Americas has issued a voluntary recall for its Inner Sheath (Model A2660) following reports of the device's ceramic tip breaking during urological procedures.
What Happened
Olympus Corporation of the Americas has initiated a voluntary recall of its Inner Sheath devices used in urological medical procedures. The recall was triggered by complaints that the ceramic tip of the resection sheath can break during use, potentially posing risks during endoscopic diagnosis and treatment.
Which Products Are Affected
The recall involves the following medical device:
- Product Name: Olympus Inner Sheath
- Model Number: A2660
- UDI: 04042761004176
- Lot Information: All Lots
- Quantity: 9 units
- Distribution: US Nationwide
What You Should Do
According to the firm’s notification, the recall was initiated via letter to affected customers. Healthcare facilities and providers should immediately check their inventory for Model No. A2660. If the device is present, users should follow the specific instructions provided by Olympus Corporation of the Americas regarding the handling and return of the affected units. For further inquiries, the firm is located at 3500 Corporate Pkwy, Center Valley, PA.
Why This Matters
A breaking ceramic tip during a urological procedure could lead to patient injury or require additional medical steps to retrieve fragments from the body. This Class II recall indicates that the product may cause temporary or medically reversible adverse health consequences.
Source
Source: FDA Official Notice