{
  "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": "2026-10-22",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 13
    }
  },
  "results": [
    {
      "cfres_id": "166698",
      "product_res_number": "Z-3265-2018",
      "event_date_initiated": "2018-08-08",
      "event_date_created": "2018-09-27",
      "recall_status": "Terminated",
      "event_date_terminated": "2019-08-28",
      "res_event_number": "80837",
      "product_code": "HQE",
      "k_numbers": [
        "K162342"
      ],
      "product_description": "Bausch + Lomb Stellaris Elite 20 GA Vit Cutter, Model BL5626, 7500 cpm, packaged in sterile pouches, 6/shipper.",
      "code_info": "Lot numbers V9400, exp. 11/6/2018; W1439, exp. 8/19/2019; and W1467, exp. 8/26/2019, UDI 00757770058891.",
      "firm_fei_number": "1920664",
      "recalling_firm": "Bausch & Lomb Inc",
      "address_1": "3365 Tree Court Industrial Blvd",
      "city": "Saint Louis",
      "state": "MO",
      "postal_code": "63122-6615",
      "additional_info_contact": "Kaylean Premeaux\n949-398-5626",
      "reason_for_recall": "The back cap separates from the body of the vitrectomy cutter.",
      "root_cause_description": "Nonconforming Material/Component",
      "action": "Recall letters flagged URGENT MEDICAL DEVICE VOLUNTARY RECALL dated 8/8/2018 were issued 8/8/2018 via certified mail return receipt to the U.S. consignees.   Letters for foreign consignees were dated 8/7/2018 and were flagged URGENT FIELD SAFETY NOTICE.",
      "product_quantity": "33 cases",
      "distribution_pattern": "Distribution was made to AL, AZ, CA, CO, FL, GA, HI, IL, IN, KS, KY, MA, ME, MO, MT, NC, NJ, NY, OH, OK, OR, PA, TN, TX, UT, and WV.  There was government distribution but no military distribution.  Foreign distribution was made to Russia, Romania, Poland, The Netherlands, Jordan, Italy, Israel, Switzerland, Hungary, Greece, Guadeloupe, Great Britain, France, Spain, Singapore, Malaysia, and Thailand.",
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        "device_name": "Instrument, Vitreous Aspiration And Cutting, Ac-Powered",
        "medical_specialty_description": "Ophthalmic",
        "regulation_number": "886.4150",
        "device_class": "2",
        "registration_number": [
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