Z-1866-2016Class II

Integra MicroFrance Monopolar and Bipolar Electrosurgical Instruments

Name: Z-1866-2016 Integra MicroFrance Monopolar and Bipolar Electrosurgical Instruments
Creator: Integra LifeSciences Corp.
Published: 2016-03-07
License: https://open.fda.gov/license/

Integra LifeSciences Corporation / initiated 2016-03-07 / Terminated

FDA source

Integra LifeSciences Corp. began a recall of Integra MicroFrance Monopolar and Bipolar Electrosurgical Instruments on 2016-03-07. FDA classified it as Class II and gives the reason as "Reports relating to unintended patient or operator burns or operator electric shock for some of Integra's MicroFrance electrosurgical instruments". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-1866-2016
Classification: Class II
Status: Terminated
Initiated: 2016-03-07
Posted: 2016-05-31
Terminated: 2017-03-31
Recalling firm: Integra LifeSciences Corporation
Product: Integra MicroFrance Monopolar and Bipolar Electrosurgical Instruments
Product code: GEI Electrosurgical, Cutting & Coagulation & Accessories
Reason for recall: Reports relating to unintended patient or operator burns or operator electric shock for some of Integra's MicroFrance electrosurgical instruments.
FDA root cause: Other
Action: Integra sent an "Urgent Medical Device Correction" Field Safety Notice and an addendum dated March 7, 2016 to their customers via traceable courier service.
Quantity in commerce: 30,146 Instruments
Distribution: AR, CA, CO, FL, IN, KY, MA, MI, NC, NJ, NY, NM, OH, TN, TX, WA and WI
Product codes and lots: Catalogue No's: CEV649B5, CEV649BGP, CEV649GP, CEV8649B5, CEV8649BGP, CEV646B5, CEV647B5, CEV648B5, CEV649-5B, CEV649-5N, CEV8646B5, CEV8647B5, CEV8648B5, CEV1019-5B, CEV10195C, CEV10195D, CEV1019-5N, CEV10195NA, CEV10195R, CEV1039-5-B, CEV10395D, CEV1039-5N, CEV3911, CEV3931, CEV3941, CEV3951, CEV3961, CEV3981, CEV3991, CEV8991, CEV104M, CEV114M, CEV211, CEV220, CEV391B, CEV394B, CEV395B, CEV399B, CEV899, CEV405, CEV406, CEV407, CEV460, CEV470, CEV470-1, CEV511M, CEV514M, CEV515M, MCLP20, MCLP25, MCLP30, MCLP40, CEV8649GP, DEV9649B5, CEV9649BGP, CEV9649GP, CEV8649-5-B, CEV8649-5N, CEV9646B5, CEV9647B5, CEV9648B5, CEV9649-5-B, CEV9649-5N, CEV10395R, CEV1039G5, CEV618-5N, CEV6185R, CEV638-5N, CEV6385R, CEV720BR, CEV720R, CEV7285R, CEV605-5, CEV8911, CEV8931, CEV8941, CEV8951, CEV8961, CEV8981, CEV520M, CEV525M, CEV531-3, CEV815M, CEV891M, CEV894M, CEV895M, CEV995M, CEV996M, CEV997M, CEV998M, CM107, CM110, CM111, CM111R, CM112, CM113, CM115 and CM120. All batch numbers distributed from January 2011 to February 17, 2016.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1866-2016
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1866-2016	Class II	Terminated	Voluntary: Firm initiated	2016-06-08	2016-05-31
Z-1867-2016	Class II	Terminated	Voluntary: Firm initiated	2016-06-08	2016-05-31

Product code GEI

K993655Class IIMicro-France Electrosurgical Instruments, VariousXomed, Inc. / cleared 1999-12-21

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)