Olympus 10 French sheath recalled over ceramic tip breakage complaints
Olympus is recalling its Sheath, 10 Fr, model A37004A, used for endoscopic diagnosis and treatment in urological applications, after complaints that the ceramic tip can 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: Rubric level 3 covers risk-of-harm products where injury has not yet been reported: this is an FDA Class II recall of a device that can break during a procedure, with no injuries or hospitalisations stated in the source.
Plain-English summary
Olympus Corporation of the Americas is recalling the Olympus Sheath, 10 Fr, model number A37004A, used for endoscopic diagnosis and treatment in urological applications. About 94 units were distributed nationwide in the United States. The FDA has classified this recall as Class II.
Complaints of the ceramic tip of the resection sheath breaking have been received.
All lots are affected. The device carries UDI 04042761023092.
Facilities can identify affected devices by the model number and UDI above, and may contact Olympus Corporation of the Americas for further information.
The recalled product
- Product
- Olympus Sheath, 10 Fr. Model No. A37004A. for endoscopic diagnosis and treatment in urological applications.
- Manufacturer
- Olympus Corporation of the Americas
- Category
- Medical Device — Endoscopy
- Affected units
- 94
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. A37004A
- UDI: 04042761023092
- 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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