Olympus Resection Sheath Model A2666 Recalled Due to Ceramic Tip Breakage
Olympus recalls Model A2666 Resection Sheath for urologic use after receiving complaints of the ceramic tip breaking during procedures.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: FDA Class II recall with device failure during surgical procedures. No injuries reported, but this is a risk-of-harm product where injury has not yet been reported, meeting the High severity criteria.
Plain-English summary
Olympus Corporation of the Americas is recalling its Model A2666 Resection Sheath, a medical device used for urologic surgical procedures. The recall covers all units with UDI 04042761004244 and was distributed nationwide in the United States.
The company has received complaints of the ceramic tip breaking during use. This mechanical failure could cause bleeding or other injuries during urologic resection procedures.
Healthcare facilities and patients using this device should stop using it immediately and contact Olympus for a replacement. The FDA has classified this as a Class II recall.
The recalled product
- Product
- Olympus Resection Sheath; Model No. A2666. Resection sheath for urologic applications.
- Manufacturer
- Olympus Corporation of the Americas
- Hazard
- device-failure
- bleeding
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (3)
- Model No. A2666
- UDI: 04042761004244
- All Lots
Distribution
Distributed nationwide across the United States.
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