{
  "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": "131860",
      "product_res_number": "Z-0773-2015",
      "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, 3MM PEEK MONOPOLAR HANDLE, P/N 0250282045\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": "843744 847017 942768 943108 943436 943515 944197 944825 945711 1040927 1042098 1042468 1042513 1042514 1042957 1043819 1045057 1045626 1046584 1140930 1141656 1142239 1144237 1144342 1145343 1146674 1147037 1242641 1243948 1246163H 1340920H 1341894 1341894H 1344199 1344872 1344990 1345272 1345272H 1346215 1346215H 1346684 1440429 1441830",
      "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": {}
    }
  ]
}