Agency classClass IIOur severity:High FDA (Devices)·Z-2566-2016·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 package may be compromised, potentially breaching the sterile barrier.

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 3/5 (High).

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 Wire J-Hook Electrodes (Item Code: E277345) due to a potential compromise of the package that could result in a breach of the sterile barrier. The affected lot range is 210409X through 61220133X, and the recall involves 24,870 units.

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 covers worldwide distribution, including the United States (nationwide) and internationally to Australia, Canada, Japan, Korea, Hong Kong, and Thailand.

The FDA has classified this recall as Class II, meaning the use of, or exposure to, the violation could cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote. No specific instructions for consumers are provided in the source text, but the recall is driven by the risk of sterility failure.

The recalled product

Product: Valleylab Laparoscopic Wire J-Hook Electrode 45CM Item Code: E277345 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
Category: Medical Device — Surgical Instruments
Hazard: sterility-breach
Affected units: 24,870

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: 210409X through 61220133X

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 →

Same manufacturer · Medtronic

See all →

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Moderate
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Severe
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Same hazard · sterility breach