Medtronic Recalls Valleylab Laparoscopic Electrodes Due to Sterile Barrier Risk
Medtronic is recalling 332 Valleylab Laparoscopic Flat 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 risk but does not meet the criteria for Severe (Class I or reported hospitalization) or High (high-risk pathogens without illness). It fits the Moderate category for a Class II recall without reported injuries.
Plain-English summary
Medtronic is recalling 332 units of the Valleylab Laparoscopic Flat L-Hook Electrode 28cm (Item Code: E278428). The recall is due to a potential compromise of the package, which could result in a breach of the sterile barrier.
The affected products were distributed worldwide, including nationwide in the United States and internationally to Australia, Canada, Japan, Korea, Hong Kong, and Thailand. The affected lot range is 209220X through 52140033X.
These electrodes are indicated for use in laparoscopic and thoracoscopic surgical procedures. Healthcare providers should check their inventory for the affected item code and lot range. If the product is found, it should be removed from use and returned to Medtronic.
The recalled product
- Product
- Valleylab Laparoscopic Flat L-Hook Electrode 28cm Item Code: E278428 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
- 332
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: 209220X through 52140033X
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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