Stryker Endoscopy: Medical Device Recall in 2014 - (Recall #: Z-0738-2015)

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, PARK FORCEPS, P/N 0250080733 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-0738-2015

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:

541778 645498 746494 940777 940819 942547 943493 1040240 1040242 1041188 1041617 1042440 1042802 1042810 1042824 1042825 1141217 1141787 1142297 1144497 1144989 1145355 1145793 1146356 1146666 1240947 1241795 1242136 1245816 1246637 1342739 1344134 1344201 1344205 1344875 1345230 1345275 1345417 1345518 1345735 1440481 1441633 1441835 1442174 246637

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