HF Resection Electrodes Recalled for Incompatible Packaged Cable
Olympus Corporation is recalling HF Resection Electrodes because an incompatible cable may be included in packaging. The cable cannot connect to the electrosurgical generator, potentially delaying or canceling surgery.
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 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: This is an FDA Class II recall with no reported injuries or illnesses. The hazard is a packaging error where an incompatible cable may be included with the electrodes. Because the cable cannot connect to the device, it presents no patient harm risk, only potential surgical delay. This meets the criteria for Moderate severity.
Plain-English summary
Olympus Corporation of the Americas is recalling HF Resection Electrodes with model numbers WA22602S, WA22603S, WA22621S, and WA22657S. The recall involves 186 boxes containing 930 individual electrodes distributed nationwide.
The recall occurs because an incompatible cable may be packaged with the electrodes. The cable cannot be connected to the electrosurgical generator, which may result in delay or cancellation of surgical procedures that require these electrodes.
The recalled product
- Product
- HF Resection Electrodes, Model Numbers WA22602S, WA22603S, WA22621S and WA22657S
- Manufacturer
- Olympus Corporation of the Americas
Distribution
Distributed nationwide across the United States.
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