Olympus Corporation of the Americas recalled the Inner Sheath 21 Fr., Model No. A2660T, on November 11, 2025. The recall follows reports of the ceramic tip breaking during use. Patients and healthcare providers should stop using the device immediately.
Complaints of the ceramic tip of the resection sheath breaking have been received.
Patients and healthcare providers should stop using this device immediately. Follow the recall instructions provided by the manufacturer. Contact Olympus Corporation of the Americas or your healthcare provider for instructions. Notification method: Letter
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The recalled product is the Olympus Inner Sheath 21 Fr., Model No. A2660T. It was distributed nationwide in the United States. The exact quantity recalled is one unit.
The ceramic tip of the resection sheath may break, posing a risk of injury during endoscopic procedures. This recall is classified as Class II, indicating a potential for serious injury.
No specific incident counts have been reported, but the potential for injury exists due to the ceramic tip breaking.
Patients and healthcare providers should stop using the device immediately. Contact Olympus Corporation of the Americas or your healthcare provider for further instructions.
For more information, visit the Olympus Corporation of the Americas website or call their customer service.
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