Z-0100-2015Class II

GYRUS ACMI, REF 3345 -Everest BiCOAG MOLly Forceps 5mm/45cm REF 3345PK - PKS MOLly Forceps 5mm/45cm REF 3640...

Name: Z-0100-2015 GYRUS ACMI, REF 3345 -Everest BiCOAG MOLly Forceps 5mm/45cm REF 3345PK - PKS MOLly Forceps 5mm/45cm REF 3640...
Creator: Gyrus Medical, Inc
Published: 2014-08-27
License: https://open.fda.gov/license/

Gyrus ACMI, Inc. / initiated 2014-08-27 / Terminated / root cause: packaging

FDA source

Gyrus Medical, Inc began a recall of GYRUS ACMI, REF 3345 -Everest BiCOAG MOLly Forceps 5mm/45cm REF 3345PK - PKS MOLly Forceps 5mm/45cm REF 3640 -Everest BiCOAG Macro Jaw Forceps 5mm/45cm REF... on 2014-08-27. FDA classified it as Class II and gives the reason as "Due to an anomaly in the packaging process, it is possible that a defective seal could be present that may allow a breach of the package's sterile barrier and may compromise the sterility of the product". 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-0100-2015
Classification: Class II
Status: Terminated
Initiated: 2014-08-27
Posted: 2014-10-21
Terminated: 2015-09-15
Recalling firm: Gyrus ACMI, Inc.
Product: GYRUS ACMI, REF 3345 -Everest BiCOAG MOLly Forceps 5mm/45cm REF 3345PK - PKS MOLly Forceps 5mm/45cm REF 3640 -Everest BiCOAG Macro Jaw Forceps 5mm/45cm REF 3640PK- PKS Macro Jaw Forceps 5mm/45cm REF 3844- Everest BiCOAG LP Scissors 5mm/45cm REF 910010PK- PKS MOLly Forceps 5mm/45cm Single-use, sterile devices intended 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: Due to an anomaly in the packaging process, it is possible that a defective seal could be present that may allow a breach of the package's sterile barrier and may compromise the sterility of the product.
Root cause tag: packaging
FDA root cause: Packaging process control
Action: Olympus sent a Medical Device Recall letter dated August 26, 2014, via FEDEX to all affected consignees. The letter described the issue and the product involved in the recall. It also described the action that the consignee needs to take. Consignees were instructed to cease further use of the device, quarantine it and return it to the manufacturer.Consigness were instructed to complete and return by fax (484-896-7128) the questionnaire enclosed. If the product was further distributed consignees should notify their customers of the product recall. For additional information they can call 484-896-5688. For questions regarding this recall call 484-896-5688.
Quantity in commerce: 5520 US, 40 OUS
Distribution: Worldwide Distribution - USA including US: AL, AZ, CA, FL, GA, HI, IL, IN, IA, KY, MA,MI,MS, NJ, NY, NC, OH, PA, SC, TN, UT, and WA. Internationally to ITALY, SPAIN, UNITED KINGDOM, and CHINA.
Product codes and lots: All product manufactured before July 28, 2014.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0100-2015
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0100-2015	Class II	Terminated	Voluntary: Firm initiated	2014-10-29	2014-10-20

Product code GEI

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)