Olympus 28 French resection sheath recalled over ceramic tip breakage
Olympus is recalling its Resection Sheath, 28 Fr, model A22043A, used in urologic applications, after complaints that the ceramic tip of the resection sheath can break.
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: 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 Resection Sheath, 28 Fr, model number A22043A, a resection sheath for urologic applications. About 118 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 04042761021005.
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 Resection Sheath, 28 Fr.; Model No. A22043A. Resection sheath for urologic applications.
- Manufacturer
- Olympus Corporation of the Americas
- Category
- Medical Device — Endoscopy
- Affected units
- 118
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. A22043A
- UDI: 04042761021005
- 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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