Medtronic Recalls Valleylab Laparoscopic Electrodes Due to Sterile Barrier Compromise
Medtronic is recalling 6,720 Valleylab Laparoscopic Straight Spatula Electrodes because the package 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, and the hazard is a potential sterile barrier breach without reported injuries or illnesses, fitting the criteria for a moderate severity precautionary recall.
Plain-English summary
Medtronic is recalling 6,720 units of the Valleylab Laparoscopic Straight Spatula Electrode 28CM (Item Code: E278028). The recall is due to a potential compromise of the package that could result in a breach of the sterile barrier. The affected lot range is 212060X through 60520072X.
These devices 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 products were distributed worldwide, including nationwide in the United States and internationally to Australia, Canada, Japan, Korea, Hong Kong, and Thailand.
The source text does not specify specific actions for consumers or healthcare providers, nor does it report any illnesses or injuries associated with this recall.
The recalled product
- Product
- Valleylab Laparoscopic Straight Spatula Electrode 28CM Item Code: E278028 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 s
- Manufacturer
- Medtronic
- Hazard
- Affected units
- 6,720
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: 212060X through 60520072X
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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