{
  "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": "2026-09-17",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 6
    }
  },
  "results": [
    {
      "cfres_id": "215000",
      "product_res_number": "Z-2440-2025",
      "event_date_initiated": "2025-07-03",
      "event_date_posted": "2025-08-26",
      "recall_status": "Open, Classified",
      "res_event_number": "97260",
      "product_code": "FSP",
      "product_description": "Orascoptic Superior Visualization\nCustom loupes with Dragonfly frames",
      "code_info": "All Serial numbers manufactured between September 7, 2023 - May 14, 2025",
      "firm_fei_number": "3007515681",
      "recalling_firm": "Orascoptic Surgical Acuity",
      "address_1": "717 W Collins Ave",
      "city": "Orange",
      "state": "CA",
      "postal_code": "92867-5513",
      "additional_info_contact": "North America Customer Care & Technical Support\n800-369-3698",
      "reason_for_recall": "Due to complaints, loupe nose pads containing nickel may cause an allergic reaction.",
      "root_cause_description": "Labeling design",
      "action": "On June 24, 2025,  Orascoptic Superior Visualization issued a Urgent: Loupe Advisory Notice. On July 7, 2025 a revised letter was issued to remove cleaning instructions. On August 13, 2025,  Orascoptic Superior Visualization issued an Urgent: Medical Device Recall expansion notification to include additional nose pad accessory kits and additional information on the reason for recall, the risk to patient and the steps that should be taken.  Orascoptic asked consignees to take the following actions: \n\n1. To confirm if your loupe is subject to this notice, please visit orascoptic.com\twebsite to search the serial number. \n\"\tDragonfly loupe: the serial number is printed on the inside of the right temple arm.\n\"\tPhantom sport frame: the serial number is printed on the loupe case name badge plate. \n2. If you have given your custom loupe to someone else, please forward a copy of this notice to that person.\n3. To request a replacement nose pad that does not contain nickel, please visit orascoptic.com. \n4. Visit Orascoptic.com  for directions on how to replace the nose pad for your frame. Contact technical support if you need additional support at 800.369.3698. Please discard the old nose pad.\n5. Acknowledge receipt of this notice and contacting Orascoptic.",
      "product_quantity": "15,245 units",
      "distribution_pattern": "Worldwide - US Nationwide distribution including in the states of AK, AL, AP, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WI, WV, WY and the countries of AE, AT,  AU, BR, CA\t, CH, CZ, DE, DZ, EE, ES, FI, FR, GB, GR, HR, HU, IE, IL, IT, JP, KW, KY, LT, MA, MY, NL, NO, NZ, PL, PR, PT, RO, SE, SG, SK, TR.",
      "openfda": {
        "registration_number": [
          "3044150131",
          "1836161",
          "3015136927",
          "3013403214",
          "3016875543",
          "3023808059",
          "3036269993",
          "1412854",
          "8010482",
          "2127132",
          "2434008",
          "3014683120",
          "1051614",
          "3008860098",
          "3026861828",
          "2916714",
          "2126670",
          "3007597038",
          "3014414462",
          "3014268446",
          "3006799849",
          "2431166",
          "8030607",
          "3042989733",
          "3011215096",
          "2431764",
          "8021788",
          "3022320321",
          "3014326245",
          "1927430",
          "9616704",
          "3026312050",
          "3003969012",
          "3011778089",
          "3023388535",
          "9610612",
          "3006550126",
          "9616250",
          "1720747",
          "3006697692",
          "3015316279",
          "1645452",
          "3025436467",
          "3004513872",
          "3001644167",
          "3015895045",
          "3005515469",
          "3011554142",
          "3002821232",
          "3009768364",
          "3011279497",
          "8010427",
          "3016891393",
          "3031582434",
          "3003807268",
          "3003848022",
          "3023194894",
          "1926681",
          "3042172872",
          "3025376090"
        ],
        "fei_number": [
          "3006509795",
          "3044150131",
          "3015136927",
          "3013403214",
          "3016875543",
          "3023808059",
          "3036269993",
          "1412854",
          "2127132",
          "2434008",
          "3014683120",
          "1051614",
          "3002806315",
          "3008860098",
          "3026861828",
          "2916714",
          "2126670",
          "6034",
          "3014414462",
          "3014268446",
          "3006799849",
          "1000347621",
          "3042989733",
          "3011215096",
          "2431764",
          "3000302881",
          "3014326245",
          "3022320321",
          "1927430",
          "5682",
          "3006550126",
          "3026312050",
          "3003969012",
          "3011778089",
          "3023388535",
          "1720747",
          "3006697692",
          "3015316279",
          "3025436467",
          "3004513872",
          "3002750084",
          "3001644167",
          "1000139591",
          "3015895045",
          "3005515469",
          "3011554142",
          "3002821232",
          "1000292048",
          "3009768364",
          "3011279497",
          "3016891393",
          "3031582434",
          "3003807268",
          "3003848022",
          "3003772581",
          "3023194894",
          "1926681",
          "2523865",
          "3042172872",
          "3025376090"
        ],
        "k_number": [
          "K895248",
          "K864386",
          "K891895",
          "K861749"
        ],
        "device_name": "Loupe, Diagnostic/Surgical",
        "medical_specialty_description": "General, Plastic Surgery",
        "regulation_number": "878.4800",
        "device_class": "1"
      }
    }
  ]
}