Stryker Endoscopy: Medical Device Recall in 2014 - (Recall #: Z-0701-2015)

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, HOOK SCISSORS, 45CM, P/N 0250080573 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-0701-2015
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:

542142 840087 840778 845037 848121 940157 943731 1040938 1041996 1042072 1042485 1042720 1046194 1141403 1145070 1242916 1242932 1243556 1244078 1344775 1344878 1345291 1345424 1440908 1441384

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