Z-1983-2013Class II

GYRUS ACMI, REF 3740, Everest BiCOAG Bipolar Dissecting Forceps 5mm/45 cm, Sterile EO. GYRUS ACMI, REF...

Name: Z-1983-2013 GYRUS ACMI, REF 3740, Everest BiCOAG Bipolar Dissecting Forceps 5mm/45 cm, Sterile EO. GYRUS ACMI, REF...
Creator: Gyrus Medical, Inc
Published: 2013-07-24
License: https://open.fda.gov/license/

Gyrus ACMI, Inc. / initiated 2013-07-24 / Terminated / root cause: packaging

FDA source

Gyrus Medical, Inc began a recall of GYRUS ACMI, REF 3740, Everest BiCOAG Bipolar Dissecting Forceps 5mm/45 cm, Sterile EO. GYRUS ACMI, REF 3740PK, or REF 94201PK, PKS LYONS, Dissecting Forceps... on 2013-07-24. FDA classified it as Class II and gives the reason as "On April 29, 2013 Olympus Surgical Technologies America R&D received results from an accelerated aging study conducted as part of a new market submission. The study found that one of 60 Dissector units that underwent 3...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as packaging.

Recall record

Recall number: Z-1983-2013
Classification: Class II
Status: Terminated
Initiated: 2013-07-24
Posted: 2013-08-19
Terminated: 2014-06-20
Recalling firm: Gyrus ACMI, Inc.
Product: GYRUS ACMI, REF 3740, Everest BiCOAG Bipolar Dissecting Forceps 5mm/45 cm, Sterile EO. GYRUS ACMI, REF 3740PK, or REF 94201PK, PKS LYONS, Dissecting Forceps 5mm/45cm, Sterile EO. The Dissectors are sterile, single use electrosurgical devices that are indicated for the electrosurgical coagulation, mechanical grasping, and dissection of tissue during the performance of laparoscopic and general surgical procedures.
Product code: GEI Electrosurgical, Cutting & Coagulation & Accessories
Reason for recall: On April 29, 2013 Olympus Surgical Technologies America R&D received results from an accelerated aging study conducted as part of a new market submission. The study found that one of 60 Dissector units that underwent 3 year accelerated aging failed the dye penetration test indicating that the seal on sterile packaging was compromised. The dissector products are labeled with a 3 year shelf life.
Root cause tag: packaging
FDA root cause: Packaging process control
Action: Olympus sent a "Medical Device Recall" letter dated July 24, 2013, to all affected customers. The letter identified the problem the product and the action needed to be taken by the customer.. Customers were advised to immediately cease any further use of the product and remove it from inventory and quarantine it until is shipped back to the company. To return the product, call 1-888-524-7266 Olympus customer service representative. Customers were requested to complete and return by fax the enclosed questionnaire to 484-896-7128. If the product was further distributed then they need to identify their customers and notify them at once of the product recall.
Quantity in commerce: 1140
Distribution: Worldwide Distribution - USA (nationwide) including the states of AL, AZ, CA, FL, GA, IL, IN, KS,KY, MD, MA, MI, MN, MS, MO, NY, NC, OH, PA, SD, TN, TX, VA and WI., and the countries of BRAZIL, CHINA, AUSTRALIA, CHINA, GERMANY and INDIA.
Product codes and lots: REF 3740 150080AC 258624MC G166568CC 381809KD 408020AE JF480565 NY492562 REF 3740PK 128971JB 226730IC 226742IC 226743IC 431894CE 431895CE G128677JB REF 94201PK 102290EB 147428AC 167021CC 198596GC 204439HC 204451HC 249022KC 278142BD 320659DD 344712FD 363953ID 373761JD 389095MD 418231BE G386412KD G461037EE JF493195

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1983-2013
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1983-2013	Class II	Terminated	Voluntary: Firm initiated	2013-08-28	2013-08-19

Product code GEI

K031080Class IIEverest Bipolar Lyons Dissecting Forceps & Gyrus Bipolar Lyons Dissecting ForcepsGyrus Medical, Inc. / cleared 2003-05-16

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 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)