The Recall Desk
HighFDA (Devices)·Z-2564-2016·Announced 2016-08-24

Medtronic Recalls Valleylab Laparoscopic Electrodes Due to Sterile Barrier Risk

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 involves a risk-of-harm product (medical device) where a sterile barrier breach could lead to infection, but the source text does not report any specific injuries or illnesses, fitting the 'High' severity criteria for theoretical risk without reported harm.

Plain-English summary

Medtronic is recalling Valleylab Laparoscopic Wire J-Hook Electrodes (Item Code: E277236) due to a potential compromise of the package that could result in a breach of the sterile barrier. The affected products 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 covers 85,630 units with lot numbers ranging from 210110X through 61250197X. These products were distributed worldwide, including nationwide in the United States and internationally to Australia, Canada, Japan, Korea, Hong Kong, and Thailand.

Healthcare providers and facilities should stop using the affected lots and contact Medtronic for further instructions on how to return or dispose of the devices.

The recalled product

Product
Valleylab Laparoscopic Wire J-Hook Electrode 36CM Item Code: E277236 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
85,630

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: 210110X through 61250197X

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 →