Olympus Inner Sheath Medical Device Recalled Due to Ceramic Tip Breakage
Olympus is recalling its Inner Sheath Model A2642, a medical device used in urological procedures, after receiving 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 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: FDA Class II medical device recall with reported complaints of component failure; no hospitalization or serious injury reports explicitly stated in the source text.
Plain-English summary
Olympus Corporation of the Americas is recalling its Inner Sheath Model A2642, a medical device used for endoscopic diagnosis and treatment in urological applications. The recall is being issued because the company has received complaints of the ceramic tip of the resection sheath breaking. This device is distributed nationwide in the United States and affects all lots of Model No. A2642 with UDI 04042761004084. Consumers who have this device should contact their healthcare provider or the manufacturer for further instructions.
The recalled product
- Product
- Olympus Inner Sheath. Model No. A2642. 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. A2642
- UDI: 04042761004084
- 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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