The Recall Desk
ModerateFDA (Devices)·Z-0424-2023·Announced 2022-12-14

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.

What this means for you

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
Category
Medical Device — Electrosurgical Equipment
Hazard
  • incompatible-cable
  • packaging-error

Distribution

Distributed nationwide across the United States.

Related recalls

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