The Recall Desk
HighFDA (Devices)·Z-2565-2016·Announced 2016-08-24

Medtronic Recalls Valleylab Laparoscopic Electrodes Due to Sterile Barrier Compromise

Medtronic is recalling Valleylab Laparoscopic Wire J-Hook Electrodes because the packaging may be compromised, potentially breaching the sterile barrier.

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. The hazard involves a potential breach of the sterile barrier, which poses a risk of infection or harm during surgery, but no specific injuries or illnesses are reported in the source text.

Plain-English summary

Medtronic is recalling Valleylab Laparoscopic Wire J-Hook Electrodes (Item Code: E277336) due to a potential compromise of the package that could result in a breach of the sterile barrier. The affected lot range is 00378X through 61220135X.

The recall involves 349,629 units that were distributed worldwide, including the United States, Australia, Canada, Japan, Korea, Hong Kong, and Thailand. The product is indicated for use in laparoscopic and thoracoscopic surgical procedures.

Healthcare facilities should stop using the affected devices and contact Medtronic for further instructions regarding the recall.

The recalled product

Product
Valleylab Laparoscopic Wire J-Hook Electrode 36CM Item Code: E277336 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
Affected units
349,629

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: 00378X through 61220135X

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.

See all 25 products in this recall →