Medtronic Recalls Valleylab Laparoscopic Electrodes Due to Sterile Barrier Compromise
Medtronic is recalling Valleylab Laparoscopic Flexible Argon Blade Electrodes because the packaging may be compromised, potentially breaching the sterile barrier.
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: The recall is classified as FDA Class II, but the source text explicitly states no illnesses or injuries have been reported. The hazard is a theoretical breach of the sterile barrier, which fits the criteria for a moderate severity score (2) as a precautionary recall without reported harm.
Plain-English summary
Medtronic is recalling Valleylab Laparoscopic Flexible Laparoscopic Argon Blade Electrodes 28CM (Item Code: E258028). The recall involves 6,769 units distributed worldwide, including the United States, Australia, Canada, Japan, Korea, Hong Kong, and Thailand. The affected lot range is 210573X through 60870080X.
The reason for the recall is the potential for compromise of the package, which could result in a breach of the sterile barrier. These electrodes are indicated for use in laparoscopic and thoracoscopic surgical procedures where the delivery of electrosurgical current, irrigation, and suction via a single handset is desirable.
Healthcare facilities and users should stop using the affected products and contact Medtronic for further instructions. The source text does not report any specific illnesses or injuries associated with this recall.
The recalled product
- Product
- Valleylab Laparoscopic Flexible Laparoscopic Argon Blade Electrodes 28CM Item Code: E258028 The Valleylab Laparoscopic Handset and Electrodes are indicated for use in laparoscopic and thoracoscopic surgical procedures where the delivery of electrosurgical current, irrigation an
- Manufacturer
- Medtronic
- Hazard
- Affected units
- 6,769
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 (1)
- Affected Lot Range: 210573X through 60870080X
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 25 recalled by Medtronic 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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