Medtronic Valleylab Laparoscopic Electrode Recall for Sterile Barrier Compromise
Medtronic is recalling Valleylab Laparoscopic Curved Spatula Electrodes due to a potential sterile barrier breach. The recall covers lots 209358X through 60870083X distributed worldwide.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall is classified as FDA Class II and involves a risk-of-harm product (sterile barrier breach) where injury has not yet been reported, fitting the 'High' severity criteria.
Plain-English summary
Medtronic is recalling Valleylab Laparoscopic Curved Spatula Electrode Retractable 28CM (Item Code: E2781R28ASP) because of a potential compromise of the package that could result in a breach of the sterile barrier. 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 recall affects lot numbers 209358X through 60870083X. The products were distributed worldwide, including nationwide in the United States and internationally to Australia, Canada, Japan, Korea, Hong Kong, and Thailand. The FDA has classified this recall as Class II.
Healthcare facilities and users should stop using the affected devices and contact Medtronic for further instructions. This recall is a precautionary measure to prevent the use of devices that may not be sterile.
The recalled product
- Product
- Valleylab Laparoscopic Curved Spatula Electrode Retractable 28CM Item Code: E2781R28ASP The Valleylab Laparoscopic Handset and Electrodes are indicated for use in laparoscopic and thoracoscopic surgical procedures where the delivery of electrosurgical current, irrigation and s
- Manufacturer
- Medtronic
- Hazard
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: 209358X through 60870083X
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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