Olympus Inner Sheath Long Model WA22017T Recalled Due to Potential Ceramic Tip Breakage
Olympus Corporation of the Americas is recalling Olympus Inner Sheath, Long (Model No. WA22017T) because the ceramic tip may break.
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: The product is a medical device with a high-risk hazard (fragmentation/breakage) where injury has not yet been reported.
Plain-English summary
Olympus Corporation of the Americas is recalling Olympus Inner Sheath, Long; Model No. WA22017T. This device is an inner sheath used for urological and gynecological applications.
The recall was initiated following complaints that the ceramic tip of the resection sheath may break.
This recall affects 1,141 units distributed nationwide in the United States.
The recalled product
- Product
- Olympus Inner Sheath, Long; Model No. WA22017T. Inner sheath for urological and gynecological applications.
- Manufacturer
- Olympus Corporation of the Americas
- Affected units
- 1,141
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. WA22017T
- UDI: 04042761051521
- 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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