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.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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
- Affected units
- 1
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.
Part of a larger recall action
This product is one of 20 recalled by Olympus Corporation of the Americas under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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