CLASS II Device recall · Reported 8 Jun 2016 · FDA Enforcement Report

Integra MicroFrance Monopolar recalled by Integra LifeSciences

Integra LifeSciences is recalling Integra MicroFrance Monopolar and Bipolar Electrosurgical Instruments, distributed in 17 states. The recall was initiated on 7 Mar 2016 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesCatalogue No: CEV669E. All batch numbers distributed from January 2011 to February 17, 2016.

Quantity recalled2,487 Instruments

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-1867-2016
FDA event ID: 73684
Recalling firm: Integra LifeSciences, Plainsboro, NJ
Classification: Class II
Status: Terminated
Recall initiated: 7 Mar 2016
FDA classified: 31 May 2016
Reported: 8 Jun 2016
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Other Reasons
Device type: Surgical Instruments

Timeline

7 Mar 2016	Recall initiated by company
31 May 2016	Classified by FDA	+85 days
8 Jun 2016	Published in enforcement report	+8 days

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

Reason for recall

Reports relating to unintended patient or operator burns or operator electric shock for some of Integra's MicroFrance electrosurgical instruments.

Product as listed by the FDA

Integra MicroFrance Monopolar and Bipolar Electrosurgical Instruments

Where it was distributed

AR, CA, CO, FL, IN, KY, MA, MI, NC, NJ, NY, NM, OH, TN, TX, WA and WI

Arkansas California Colorado Florida Indiana Kentucky Massachusetts Michigan North Carolina New Jersey New Mexico New York Ohio Tennessee Texas Washington Wisconsin

Questions about this recall

Is Integra MicroFrance Monopolar and Bipolar Electrosurgical Instruments recalled?

Yes. Integra LifeSciences recalled Integra MicroFrance Monopolar and Bipolar Electrosurgical Instruments on 7 Mar 2016. The recall is Class II and its status is Terminated. Recall number Z-1867-2016.

Why was it recalled?

Reports relating to unintended patient or operator burns or operator electric shock for some of Integra's MicroFrance electrosurgical instruments.

Which lots are affected?

Catalogue No: CEV669E. All batch numbers distributed from January 2011 to February 17, 2016.

Where was it sold?

AR, CA, CO, FL, IN, KY, MA, MI, NC, NJ, NY, NM, OH, TN, TX, WA and WI

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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