Olympus Recalls Inner Sheath Model A2642 Over Reports of Breaking Ceramic Tips
Olympus Corporation of the Americas is recalling its Inner Sheath Model A2642 after reports that the device's ceramic tip can break during urological procedures.
What Happened
Olympus Corporation of the Americas has initiated a voluntary Class II recall of the Olympus Inner Sheath, Model No. A2642. The recall was issued following reports and complaints that the ceramic tip of the resection sheath can break during use.
Which Products Are Affected
The recall includes all lots of the following product:
- Product Name: Olympus Inner Sheath
- Model Number: A2642
- UDI: 04042761004084
- Distribution: Nationwide across the United States.
What You Should Do
Olympus has notified affected customers via letter. Healthcare facilities and providers should immediately check their inventory for Model A2642 and follow the instructions provided in the firm’s notification. For further assistance or questions regarding the return process, contact Olympus Corporation of the Americas at 3500 Corporate Pkwy, Center Valley, PA 18034.
Why This Matters
The breakage of a ceramic tip during a urological procedure poses a significant risk of injury to the patient, including the potential for foreign material to remain in the body or the need for additional surgical intervention to retrieve the broken fragments.
Source
This information is based on official recall data from the FDA. Recall Number: Z-1456-2026.
Source: FDA Official Notice