Olympus Resection Sheath Recalled Due to Ceramic Tip Breaking
Olympus is recalling 1,676 resection sheaths after complaints of ceramic tips breaking during urologic procedures.
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 recall with risk-of-harm product characteristics. The ceramic tip breaking poses potential injury risk during urologic procedures, though no injuries have been explicitly reported in the source text.
Plain-English summary
Olympus Corporation of the Americas is recalling approximately 1,676 Olympus Resection Sheaths, 26 Fr. (Model No. A22042A), used for urologic medical procedures. The recall affects all lots of this device distributed nationwide in the United States. The company received complaints that the ceramic tip of the resection sheath can break during use. A broken ceramic tip during a medical procedure poses a risk of harm to patients. Healthcare facilities should immediately stop using the affected devices and contact Olympus for replacement or refund.
The recalled product
- Product
- Olympus Resection Sheath, 26 Fr.; Model No. A22042A. Resection sheath for urologic applications.
- Manufacturer
- Olympus Corporation of the Americas
- Affected units
- 1,676
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. A22042A
- UDI: 04042761020985
- 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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