CLASS II Device recall · Reported 24 Aug 2016 · FDA Enforcement Report

Valleylab Laparoscopic Flat L-Hook Electrode recalled by Medtronic

Medtronic is recalling Valleylab Laparoscopic Flat L-Hook Electrode, distributed nationwide in the US. The recall was initiated on 8 Jul 2016 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesAffected Lot Range: 209220X through 52140033X

Quantity recalled332

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-2576-2016
FDA event ID: 74602
Recalling firm: Medtronic, North Haven, CT
Classification: Class II
Status: Terminated
Recall initiated: 8 Jul 2016
FDA classified: 17 Aug 2016
Reported: 24 Aug 2016
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Sterility
Device type: Surgical Instruments

Timeline

8 Jul 2016	Recall initiated by company
17 Aug 2016	Classified by FDA	+40 days
24 Aug 2016	Published in enforcement report	+7 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

Potential for compromise of the package resulting in a breach of the sterile barrier

A sterility recall means a product that must be sterile, such as an injection or eye drop, may be contaminated. Using a non-sterile product can cause serious infection.

Product as listed by the FDA

Valleylab Laparoscopic Flat L-Hook Electrode 28cm Item Code: E278428 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 handset is desirable

Where it was distributed

Worldwide Distribution - US (nationwide) and Internationally to Australia, Canada, Japan, Korea, Hong Kong, Thailand,

Nationwide

Questions about this recall

Is Valleylab Laparoscopic Flat L-Hook Electrode recalled?

Yes. Medtronic recalled Valleylab Laparoscopic Flat L-Hook Electrode on 8 Jul 2016. The recall is Class II and its status is Terminated. Recall number Z-2576-2016.

Why was it recalled?

Potential for compromise of the package resulting in a breach of the sterile barrier

Which lots are affected?

Affected Lot Range: 209220X through 52140033X

Where was it sold?

Worldwide Distribution - US (nationwide) and Internationally to Australia, Canada, Japan, Korea, Hong Kong, Thailand,

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

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