Olympus Inner Sheath Model A2641 Recalled Over Ceramic Tip Breakage
Olympus is recalling all lots of its Inner Sheath, Model A2641, used in urological endoscopic procedures, due to complaints that the ceramic tip can break during use.
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 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: This is an FDA Class II recall. The device is used in urological procedures, and the reported ceramic tip breakage poses a risk of patient harm during medical use, which meets the rubric criterion for FDA Class II recalls involving risk-of-harm products.
Plain-English summary
Olympus Corporation of the Americas is recalling all lots of the Olympus Inner Sheath, Model No. A2641, an accessory used for endoscopic diagnosis and treatment in urological applications. The recall is based on complaints that the ceramic tip of the resection sheath can break during use.
The product was distributed nationwide in the United States. The recall includes all units manufactured under Model No. A2641 with UDI 04042761004060.
Healthcare facilities and users should immediately discontinue use of the affected device. Olympus is notifying distributors and customers directly and will arrange for replacement or credit as appropriate.
No other Olympus products are affected by this recall. Consumers or healthcare providers with questions should contact Olympus Customer Support.
The recalled product
- Product
- Olympus Inner Sheath. Model No. A2641. for endoscopic diagnosis and treatment in urological applications.
- Manufacturer
- Olympus Corporation of the Americas
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. A2641
- UDI: 04042761004060
- 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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