{
  "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": "2026-08-13",
    "results": {
      "skip": 0,
      "limit": 1,
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  },
  "results": [
    {
      "cfres_id": "120753",
      "product_res_number": "Z-0095-2014",
      "event_date_initiated": "2013-07-31",
      "event_date_posted": "2013-10-23",
      "recall_status": "Terminated",
      "event_date_terminated": "2015-06-29",
      "res_event_number": "65897",
      "product_code": "GCC",
      "product_description": "PIPELINE LS ACCESS SYSTEM, 3rd Dilator, 14 mm Insulated\n\nThe PIPELINE LS Dilators and Holding Clip are intended for sequential dilation of soft tissue and enabling proper placement of the Pipeline LS Retractor.",
      "code_info": "287105014",
      "firm_fei_number": "1526439",
      "recalling_firm": "DePuy Spine, Inc.",
      "address_1": "325 Paramount Dr",
      "city": "Raynham",
      "state": "MA",
      "postal_code": "02767-5199",
      "additional_info_contact": "Anita Barnick\n508-828-3583",
      "reason_for_recall": "Dilators and Holding Clip are being used for a secondary function of neuromonitoring, for which it is not 510(k) cleared.",
      "root_cause_description": "Under Investigation by firm",
      "action": "DePuy Synthes sent an Urgent Voluntary Product Recall Notification letter dated July 30, 2013, to all affected consignees via Fed Ex overnight delivery.\nConsignees were informed that DePuy Spine, Inc. is voluntarily recalling all lots of the PIPELINE LS ACCESS SYSTEM Dilators (1 st, 2nd, 3rd, and 4th) and Holding Clip. They were asked to review inventory located at their facility and quarantine any products listed in this recall notice. Consignees were instructed to contact their local DePuy Synthes Spine Sales Consultant to return any inventory located within their facility.\nConsignees with questions were instructed to call 508-828-3583.",
      "product_quantity": "102 units",
      "distribution_pattern": "Nationwide Distribution including the states of AR, AZ, CA, CO, CT, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MT, NC, ND, NE, NH, NJ, NY, OH, OK, OR, PA, SC, SD, TN, TX, VA, WA, WI, WV, and WY.",
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        "device_name": "Dilator, Catheter",
        "medical_specialty_description": "General, Plastic Surgery",
        "regulation_number": "878.4200",
        "device_class": "1"
      }
    }
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}