Olympus resection sheath models A22014A and A22014T recalled for breakage
Olympus is recalling Resection Sheath models A22014A and A22014T, used for endoscopic diagnosis and treatment in urological applications, after complaints that the ceramic tip 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, model numbers A22014A and A22014T, used for endoscopic diagnosis and treatment in urological applications. About 29 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. Model A22014A carries UDI 04042761020893 and model A22014T carries UDI 04042761020909.
Facilities can identify affected devices by the model numbers and UDIs above, and may contact Olympus Corporation of the Americas for further information.
The recalled product
- Product
- Olympus Resection Sheath. Model No. A22014A and A22014T. for endoscopic diagnosis and treatment in urological applications.
- Manufacturer
- Olympus Corporation of the Americas
- Category
- Medical Device — Endoscopy
- Affected units
- 29
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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