{
  "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": "2026-08-20",
    "results": {
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  "results": [
    {
      "cfres_id": "131760",
      "product_res_number": "Z-0692-2015",
      "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, BIPOLAR FORCEPS, FENESTRATED, 45CM, P/N 0250080350.\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": "213973 913561 913953 915432 915435 915681 915683 915945 915946 915947 915948 1013275 1014467 1014468 1014634 1014640 1014749 1014944 1015258 1015259 1015407 1015463 1015464 1015772 1015866 1015867 1016305",
      "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": {}
    }
  ]
}