{
  "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": "2026-09-05",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "cfres_id": "219263",
      "product_res_number": "Z-1943-2026",
      "event_date_initiated": "2026-03-12",
      "event_date_posted": "2026-04-24",
      "recall_status": "Open, Classified",
      "res_event_number": "98627",
      "product_code": "OCU",
      "product_description": "Mesh Style Tip Protectors\nCSW-03-2.0 Open-end style\nCSW-04-4.0 Closed-end style",
      "code_info": "No UDI.\nAll lots affected.",
      "firm_fei_number": "1000160387",
      "recalling_firm": "Healthmark Industries Co., Inc.",
      "address_1": "18600 Malyn Blvd",
      "city": "Fraser",
      "state": "MI",
      "postal_code": "48026-3496",
      "additional_info_contact": "Megan Ties\n586-774-7600",
      "reason_for_recall": "Product does not have FDA clearance.",
      "root_cause_description": "No Marketing Application",
      "action": "Firm began notifying customers on March 12, 2026 via email and phone call.\n\nThe device has been discontinued. Customers were asked to discontinue the use of the Mesh Style Tip Protectors. Unused product may be returned for credit.",
      "product_quantity": "4,291,797",
      "distribution_pattern": "US Nationwide distribution.",
      "openfda": {
        "k_number": [
          "K951104",
          "K030684",
          "K191715",
          "K202838",
          "K940780",
          "K191011"
        ],
        "device_name": "Endoscopic Storage Cover",
        "medical_specialty_description": "Gastroenterology, Urology",
        "regulation_number": "876.1500",
        "device_class": "2",
        "registration_number": [
          "1528319",
          "1047843",
          "3008058134",
          "3014749926",
          "3011050570",
          "1519132",
          "3011346938",
          "3003790304",
          "2246552"
        ],
        "fei_number": [
          "1000122656",
          "1047843",
          "3008058134",
          "3014749926",
          "3011050570",
          "1519132",
          "3011346938",
          "3003790304",
          "2246552"
        ]
      }
    }
  ]
}