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

Valleylab Laparoscopic Straight Spatula Electrode 36C recalled

Medtronic is recalling Valleylab Laparoscopic Straight Spatula Electrode 36C, 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: 215084X through 61220127X

Quantity recalled13516

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-2561-2016
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 Straight Spatula Electrode 36C Item Code: E277036 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

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: 215084X through 61220127X

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

Other products in this recall event

24 other products · FDA event 74602

This product is part of a recall event; the main page for the event is Valleylab Laparoscopic Flexible Laparoscopic Argon Electrodes 3" recalled.

Reported	Class	Recall	Company	Reason	Where
24 Aug 2016	CLASS II	Valleylab Laparoscopic Flexible Laparoscopic Argon Electrodes 3" recalled	Medtronic	Sterility	Nationwide
24 Aug 2016	CLASS II	Valleylab Laparoscopic Wire J-Hook Electrode recalled by Medtronic	Medtronic	Sterility	Nationwide
24 Aug 2016	CLASS II	Valleylab Laparoscopic Flexible Laparoscopic Argon Blade Electrodes recalled	Medtronic	Sterility	Nationwide
24 Aug 2016	CLASS II	Valleylab Laparoscopic Wire J-Hook Electrode recalled by Medtronic	Medtronic	Sterility	Nationwide
24 Aug 2016	CLASS II	Valleylab Laparoscopic Flat L-Hook Electrode recalled by Medtronic	Medtronic	Sterility	Nationwide
24 Aug 2016	CLASS II	Valleylab Laparoscopic Wire J-Hook Electrode recalled by Medtronic	Medtronic	Sterility	Nationwide
24 Aug 2016	CLASS II	Valleylab Laparoscopic Flat L-Hook Electrode Retractable recalled	Medtronic	Sterility	Nationwide
24 Aug 2016	CLASS II	Valleylab Laparoscopic Wire L-Hook Electrode Retractable recalled	Medtronic	Sterility	Nationwide
24 Aug 2016	CLASS II	Valleylab Laparoscopic Wire L-Hook Electrode Retractable recalled	Medtronic	Sterility	Nationwide
24 Aug 2016	CLASS II	Valleylab Laparoscopic Flexible Laparoscopic Argon Electrodes recalled	Medtronic	Sterility	Nationwide
24 Aug 2016	CLASS II	Valleylab Laparoscopic Curved Spatula Electrode recalled by Medtronic	Medtronic	Sterility	Nationwide
24 Aug 2016	CLASS II	Valleylab Laparoscopic Curved Spatula Electrode recalled by Medtronic	Medtronic	Sterility	Nationwide
24 Aug 2016	CLASS II	Valleylab Laparoscopic Wire J-Hook Electrode recalled by Medtronic	Medtronic	Sterility	Nationwide
24 Aug 2016	CLASS II	Valleylab Laparoscopic Wire J-Hook Electrode Retractable recalled	Medtronic	Sterility	Nationwide
24 Aug 2016	CLASS II	Valleylab Laparoscopic Curved Spatula Electrode recalled by Medtronic	Medtronic	Sterility	Nationwide
24 Aug 2016	CLASS II	Valleylab Laparoscopic Curved Spatula Electrode Retractable recalled	Medtronic	Sterility	Nationwide
24 Aug 2016	CLASS II	Valleylab Laparoscopic Wire L-Hook Electrode recalled by Medtronic	Medtronic	Sterility	Nationwide
24 Aug 2016	CLASS II	Valleylab Laparoscopic Argon Sharp Needle Electrode recalled	Medtronic	Sterility	Nationwide
24 Aug 2016	CLASS II	Valleylab Laparoscopic AP Argon Blunt Needle Electrode recalled	Medtronic	Sterility	Nationwide
24 Aug 2016	CLASS II	Valleylab Laparoscopic Flexible Laparoscopic Argon Electrodes 6" recalled	Medtronic	Sterility	Nationwide
24 Aug 2016	CLASS II	Valleylab Laparoscopic Argon Modified Flat l Electrode recalled	Medtronic	Sterility	Nationwide
24 Aug 2016	CLASS II	Valleylab Laparoscopic Straight Spatula Electrode recalled by Medtronic	Medtronic	Sterility	Nationwide
24 Aug 2016	CLASS II	Valleylab Laparoscopic Cylindrical Tip Electrode recalled by Medtronic	Medtronic	Sterility	Nationwide
24 Aug 2016	CLASS II	Valleylab Laparoscopic Flat L-Hook Electrode recalled by Medtronic	Medtronic	Sterility	Nationwide

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