Stryker Endoscopy: Medical Device Recall in 2014 - (Recall #: Z-0726-2015)

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, TENACULUM, 33CM, P/N 0250080698 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-0726-2015

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:

44485 341728 541773 543282 742876 745131 845497 847458 940778 942549 942646 943423 943739 944093 944094 945232 946004 1040629 1040994 1041614 1042529 1043032 1044517 1046583 1140148 1141926 1142615 1144486 1145071 1145795 1146118 1147099 1240111 1240545 1241176 1242120 1242928 1244073 1244707 1246143 1340125 1343307 1343553 1345287 1345526 1345630 1346245 1346662 1440422 1440461 1441380 1442253

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