{
  "meta": {
    "disclaimer": "Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. We may limit or otherwise restrict your access to the API in line with our Terms of Service.",
    "terms": "https://open.fda.gov/terms/",
    "license": "https://open.fda.gov/license/",
    "last_updated": "2026-08-22",
    "results": {
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  "results": [
    {
      "cfres_id": "131819",
      "product_res_number": "Z-0738-2015",
      "event_date_initiated": "2014-11-17",
      "event_date_posted": "2014-12-12",
      "recall_status": "Terminated",
      "event_date_terminated": "2015-07-17",
      "res_event_number": "69838",
      "product_code": "KOG",
      "product_description": "PKG, 5MM INSERT, PARK FORCEPS, P/N\n0250080733\nLaparoscopic 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.",
      "code_info": "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",
      "firm_fei_number": "2936485",
      "recalling_firm": "Stryker Endoscopy",
      "address_1": "5900 Optical Ct",
      "city": "San Jose",
      "state": "CA",
      "postal_code": "95138-1400",
      "additional_info_contact": "408-754-2000",
      "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",
      "root_cause_description": "Error in labeling",
      "action": "Stryker Endoscopy sent an Urgent Device Correction letter dated November 17, 2014, to affected customers.   The letter informed the customers of the potential hazards and actions required.  Customers were instructed to discard any old Instructions for Use for their Laparoscopic Manual Instruments and Accessories.  Download the new Instuctions for Use (IFU1000-401-070 Revision J) from the URL link below:\nwww.stryker.com/IFU1000401070\nCustomers were instructed to complete and sign the enclosed \"Acknowledgement of Receipt\" form and email them to endorecall@stryker.com or fax to (408) 855-6314.\nCustomers with questions were instructed to contact Stryker Endoscopy at 408-855-6238 or via email at endorecall@stryker.com.\nFor questions regarding this recall call 408-754-2000.",
      "product_quantity": "180,573 units total",
      "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.",
      "openfda": {}
    }
  ]
}