Stryker Endoscopy: Medical Device Recall in 2014 - (Recall #: Z-0743-2015)

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, 5MM INSERT, 45CM, DEBAKEY FORCEPS, P/N 0250080748 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-0743-2015
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 total
Code Information:

740174 746372 847633 848129 940133 940349 940374 1042921 1044418 1045036 1046691 1141654 1141925 1142630 1143140 1144223 1145066 1145938 1242452 1243548 1243795 1244657 1245116 1245601 1246159 1341990 1342387 1342748 1343007 1343306 1343424 1343729 1344276 1346100 1346243 1346419 1346659 1440421 1440480 1441378 1441632 1441833 1442623 1443218

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