Olympus resection sheath recalled due to ceramic tip breakage
Olympus is recalling 3,484 Resection Sheaths, Model A22041A, after receiving complaints that the ceramic tip can break during urologic procedures. The recall covers all lots distributed nationwide.
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: This is an FDA Class II recall involving a medical device where the ceramic tip can break during use, posing a risk of harm. No reported injuries or illnesses are mentioned in the source text, so the score is set to 3 per the rubric for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Olympus Corporation of the Americas is recalling the Olympus Resection Sheath, 24 Fr, Model No. A22041A, a device used for urologic applications. The recall affects 3,484 units distributed nationwide in the United States.
The recall is being issued because complaints have been received reporting that the ceramic tip of the resection sheath can break. No additional details regarding the cause or extent of the breakage are provided in the recall notice.
Healthcare facilities and users who have the affected resection sheaths should follow the recall instructions provided by Olympus Corporation of the Americas. The firm is the recalling party and is responsible for notifying distributors and users.
The product is identified by Model No. A22041A and UDI: 04042761020961. The recall includes all lots of the device.
The recalled product
- Product
- Olympus Resection Sheath, 24 Fr; Model No. A22041A. Resection sheath for urologic applications.
- Manufacturer
- Olympus Corporation of the Americas
- Affected units
- 3,484
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. Model No. A22041A
- UDI: 04042761020961
- 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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