Stryker Endoscopy: Medical Device Recall in 2014 - (Recall #: Z-0725-2015)

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, RETENTION GRASPER, 33CM, P/N 0250080697 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-0725-2015

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:

44496 140605 140606 345140 641239 846761 847639 940558 941264 941600 1040627 1040792 1041613 1042525 1043030 1045850 1047039 1141968 1144639 1145068 1146344 1241175 1242199 1242458 1243947 1246162 1340222D 1341522 1341572 1342759 1345289 1345603 141871 1440440 1440691 1441168 1442626 344116 642115

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