Medtronic Valleylab Laparoscopic Spatula Electrode Recall for Sterile Barrier Risk
Medtronic is recalling Valleylab Laparoscopic Straight Spatula Electrodes due to a potential sterile barrier breach. The recall affects 13,516 units distributed worldwide.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
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 Straight Spatula Electrodes (Item Code: E277036) because of a potential for compromise of the package resulting in a breach of the sterile barrier. The affected lot range is 215084X through 61220127X.
A total of 13,516 units were distributed nationwide in the US and internationally to Australia, Canada, Japan, Korea, Hong Kong, and Thailand. These devices are indicated for use in laparoscopic and thoracoscopic surgical procedures.
Healthcare providers should stop using the affected devices and contact Medtronic for further instructions. Patients who have had procedures using these devices should consult their healthcare provider if they have concerns.
The recalled product
- Product
- Valleylab Laparoscopic Straight Spatula Electrode 36C Item Code: E277036 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…
- Manufacturer
- Medtronic
- Hazard
- Affected units
- 13,516
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: 215084X through 61220127X
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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