Stryker Endoscopy: Medical Device Recall in 2014 - (Recall #: Z-0643-2015)

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:

PKG, METZENBAUM SCISSORS, STRAIGHT, P/N 0250080264. Laparoscopic Manual Instruments are intended for cutting, holding, grasping and manipulating of tissue, organs, organ areas and surgical auxiliaries such as suturing material. Some instruments have radio frequency (RF) ports which allow them to be used for electrosurgery. Laparoscopic surgical manual instruments are designed to be used endoscopically through cannulae to perform cutting, grasping, dissecting, retracting, and manipulating functions. This device does not sustain or support life.

Product Classification:

Class II

Date Initiated: November 17, 2014

Date Posted: December 24, 2014

Recall Number: Z-0643-2015

Event ID: 69838

Reason for Recall:

The parameters provided in the Laparoscopic Manual Instruments Instructions for Use (IFU 1000-401-070 Revision G or prior) do not support the unwrapped Gravity cycle and the Ethylene Oxide cycle sterilization methods

Status: Terminated

Product Quantity: 180,573 units

Code Information:

444676 744850 747211 846766 847686 847689 940825 941062 941240 944702 945444 1040418 1042252 1042641 1042642 1046930 1141610 1142468 1143262 1143499 1144311 1144491 1145814 1146361 1241908 1242646 1243540 1246126 1246648 1340098 1340237 1341587 1341998 1342754 1342755 1343012 1343692 1345519 1346667 1441561 1441817 1442227 1443326 1444430 646004

Distribution Pattern:

Worldwide Distribution - USA (nationwide) and Internationally to Algeria, Argentina, Australia, Bolivia, Brazil, Canada, Chile, China, Colombia, Costa Rica, Ecuador, France, Germany, Greece, Guam, Guatemala, India, Italy, Japan, Jordan, Kuwait, Latin America, Malaysia, Mexico, Morocco, Netherlands, New Zealand, Peru, Philippines, Poland, Portugal, Puerto Rico, Romania, Saudi Arabia, South Africa, South Korea, Spain, Sweden, Switzerland, Taiwan, Turkey, United Arab Emirates, United Kingdom, and Venezuela.

Voluntary or Mandated:

Voluntary: Firm initiated