{
  "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": "2026-09-12",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "cfres_id": "194735",
      "product_res_number": "Z-1502-2022",
      "event_date_initiated": "2022-06-24",
      "event_date_posted": "2022-08-05",
      "recall_status": "Open, Classified",
      "res_event_number": "90548",
      "product_code": "PEW",
      "k_numbers": [
        "K193269"
      ],
      "product_description": "UroLift System REF UL400-4, QTY 4 Urolfit System with Handle Release Tool",
      "code_info": "UDI/DI:  00814932020049 & 00814932020001; Lot #s: 73M2100393\t73A2200670\t73M2100394   73A2200671\t  73M2100395   73A2200672\t73A2200012   73A2200673\t73A2200013   73A2200674\t  73A2200014   73A2200832\t73A2200221   73A2200841\t73A2200222   73A2200859\t  73A2200223   73A2200905\t73A2200224   73B2200116\t73A2200225   73B2200466\t  73A2200226   73C2200567\t73A2200473  New Lots added as of 08/01/2022: 73A2200834, 73C2200911, and 73C2201163",
      "firm_fei_number": "3005791775",
      "recalling_firm": "Neotract  Inc",
      "address_1": "4155 Hopyard Rd",
      "city": "Pleasanton",
      "state": "CA",
      "postal_code": "94588-8534",
      "additional_info_contact": "Customer Service\n866-396-2111",
      "reason_for_recall": "There is the potential that during implant deployment, the device may not properly deliver a  implant.",
      "root_cause_description": "Under Investigation by firm",
      "action": "Between the dates of June 28-29, 2022,  NeoTract, Inc. (a subsidiary of Teleflex Inc.) issued a \"Urgent Medical Device Recall\" notification to affected consignees via UPS.  On July 29,2022 NeoTract, Inc.  sent an updated recall notification for additional lots that were affected. NeoTract asked consignees to take the following actions: \n\n1. If you have affected stock:\n\na. Immediately discontinue use and quarantine any products with the lot numbers listed\nabove, so that the affected products can be returned to Teleflex. Lot numbers are printed\non the product shelf carton and Tyvek labels (refer to attached appendix demonstrating\nhow you can locate the lot numbers and part catalog numbers for these products)\n\nb. Please return the affected products as follows as soon as possible:\n\nc. Complete the enclosed Recall Acknowledgement Form and email back to\nuroliftrecall@teleflex.com.\nThis will allow us to document the number of affected products you have on hand for\nreturn. A customer service representative will issue you a Return Goods Authorization\n(RGA) Number and will provide instructions for returning the products to Teleflex.\n\nd. Attach the RGA Number to the affected product and follow the shipping instructions\nprovided by Teleflex customer service.\n\n2. If you have no affected stock:\n\na. Please complete the enclosed Recall Acknowledgement Form and email back to\nuroliftrecall@teleflex.com. This will allow us to document your receipt of this letter.\n\n3. Adverse reactions or quality problems experienced with the use of this product should be reported to Teleflex Customer Service at (866) 396-2111 or may also be reported to the FDA s MedWatch  Adverse Event Reporting program either online at www.fda.gov/medwatch/report.htm, by fax to 1-800-FDA (332)-0178 or by phone, 1-\n800-FDA (332)-1088.",
      "product_quantity": "18,722 systems",
      "distribution_pattern": "US: AK\tAL\tAR\tAZ\tCA\tCO\tCT\tDC\tDE\tFL\tGA\tIA\tIL\tIN\tKS\tKY\tLA\tMA\tMD\tME\tMI\tMN\tMO\tMS\tMT\tNC\tND\tNE\tNH\tNJ\tNM\tNY\tOH\tOK\tPA\tRI\tSC\tSD\tTN\tTX\tUT\tVA\tVT\tWI\tWV\nOUS:  None",
      "openfda": {
        "k_number": [
          "DEN130023",
          "K173087",
          "K193269",
          "K133281",
          "K172359",
          "K190377",
          "K200441",
          "K153584",
          "K201837",
          "K162345",
          "K232558"
        ],
        "device_name": "Implantable Transprostatic Tissue Retractor System",
        "medical_specialty_description": "Gastroenterology, Urology",
        "regulation_number": "876.5530",
        "device_class": "2",
        "registration_number": [
          "3015181082",
          "3010220595",
          "3011137372",
          "3009307931",
          "3003898360",
          "3002907620",
          "3010041511",
          "2953359",
          "2029275"
        ],
        "fei_number": [
          "3010220595",
          "3009307931",
          "3003898360",
          "3005791775",
          "1000306431",
          "3002907620",
          "3010041511",
          "3005747797",
          "3000215205"
        ]
      }
    }
  ]
}