Medtronic Recalls Valleylab Laparoscopic Electrodes Due to Sterile Barrier Compromise
Medtronic is recalling Valleylab Laparoscopic Wire L-Hook 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. The hazard is a potential sterile barrier breach, which is a significant quality issue but does not explicitly report injuries or hospitalizations, fitting the 'Moderate' criteria for low-risk contamination or voluntary precautionary recalls where no immediate severe harm is documented.
Plain-English summary
Medtronic is recalling Valleylab Laparoscopic Wire L-Hook Electrodes (Item Code: E278328) due to a potential compromise of the package that could result in a breach of the sterile barrier. The affected products 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.
The recall covers 42,900 units distributed worldwide, including the United States (nationwide), Australia, Canada, Japan, Korea, Hong Kong, and Thailand. The affected lot range is 209965X through 60870090X.
Healthcare facilities should stop using the affected products and contact Medtronic for further instructions. This recall is classified as Class II by the FDA, indicating that use of the product could, in some cases, cause temporary or medically reversible adverse health consequences.
The recalled product
- Product
- Valleylab Laparoscopic Wire L-Hook Electrode 28CM Item Code: E278328 The Valleylab Laparoscopic Handset and Electrodes are indicated for use in laparoscopic and thoracoscopic surgical procedures where the delivery of electrosurgical current, irrigation and suction via a single
- Manufacturer
- Medtronic
- Hazard
- Affected units
- 42,900
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: 209965X through 60870090X
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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