Medtronic Recalls Valleylab Laparoscopic Electrodes Due to Sterile Barrier Risk
Medtronic is recalling Valleylab Laparoscopic AP Argon Blunt Needle 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 Valleylab Laparoscopic AP Argon Blunt Needle Electrodes (Item Code: E258328) due to a potential compromise of the package that could result in a breach of the sterile barrier. The affected units are distributed worldwide, including in the United States, Australia, Canada, Japan, Korea, Hong Kong, and Thailand.
The recall involves 2,920 units with lot numbers ranging from 210556X through 60520063X. 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 providers and facilities should stop using the affected products and contact Medtronic for further instructions on how to return or dispose of the units.
The recalled product
- Product
- Valleylab Laparoscopic AP Argon Blunt Needle Electrode 28cm Item Code: E258328 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
- Manufacturer
- Medtronic
- Hazard
- Affected units
- 2,920
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: 210556X through 60520063X
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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