Gyrus Medical, Inc: Medical Device Recall in 2014 - (Recall #: Z-0100-2015)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2014.

Data Source: FDA.

Product Description:

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 Classification:

Class II

Date Initiated: August 27, 2014

Date Posted: October 29, 2014

Recall Number: Z-0100-2015

Event ID: 69226

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.

Status: Terminated

Product Quantity: 5520 US, 40 OUS

Code Information:

All product manufactured before July 28, 2014.

Distribution Pattern:

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.

Voluntary or Mandated:

Voluntary: Firm initiated