{
  "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": {
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  "results": [
    {
      "cfres_id": "216204",
      "product_res_number": "Z-0135-2026",
      "event_date_initiated": "2025-09-06",
      "event_date_posted": "2025-10-10",
      "recall_status": "Open, Classified",
      "res_event_number": "97640",
      "product_code": "HMZ",
      "product_description": "C-Rex UNO Microinterventional Goniotomy Instrument. Model Number: CRX-120. \n\nProduct Description: The C-Rex UNO Microinterventional Goniotomy Instrument is a sterile single use disposable manual surgical instrument used in ophthalmic procedures for ab interno goniotomy and inner wall trabeculotomy.",
      "code_info": "1. Model Number: CRX-120; UDI: +B962CRX1200/$$7351729/16D20250501/14D20260501/Q1$; Lot Number 351729; Exp date 05/2026. \n\n2. Model Number: CRX-120 UDI: +B962CRX1200/$$7351759/16D20250501/14D20260501/Q1%; Lot Number: 351759; Exp date 05/2026.",
      "firm_fei_number": "3017891009",
      "recalling_firm": "Iantrek Inc.",
      "address_1": "216 Weybosset St Ste 2 216 Weybosset St",
      "address_2": "Ste 2",
      "city": "Providence",
      "state": "RI",
      "postal_code": "02903-3734",
      "additional_info_contact": "David Robson\n401-4138783",
      "reason_for_recall": "Potential for compromised integrity of the sterile packaging.",
      "root_cause_description": "Process control",
      "action": "Iantrek notified consignees on 09/06/2025 via email.   Consignees were instructed to immediately remove and quarantine all affected units to prevent their use, notify personnel or customers if affected units were forwarded to other facilities. Consignees may also alternatively provide Iantrek with contact information so that they can notify them on the customer's behalf. An Iantrek representative will be contacting each consignee immediately to help facilitate removal, return and replacement of affected units. They will arrange to have replacement product shipped to consignees at no cost.",
      "product_quantity": "198",
      "distribution_pattern": "US Nationwide distribution in the states of AL, AZ, CA, CT, DE, FL, GA, ID, IL, MD, MI, MN, MO, MS, NE, NJ, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, WA, WI.",
      "openfda": {
        "device_name": "Trabeculotome",
        "medical_specialty_description": "Ophthalmic",
        "regulation_number": "886.4350",
        "device_class": "1",
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