{
  "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": "2026-09-10",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "cfres_id": "218746",
      "product_res_number": "Z-1573-2026",
      "event_date_initiated": "2026-02-18",
      "event_date_posted": "2026-03-18",
      "recall_status": "Open, Classified",
      "res_event_number": "98439",
      "product_code": "HKO",
      "product_description": "Brand Name: Welch Allyn, Inc.\nProduct Name: Welch Allyn Spot Vision Screener VS100\nModel/Catalog Number: VS100\nSoftware Version: Software version 3.2.0.1\nProduct Description: Welch Allyn Spot Vision Screener VS100, FDA product code name: Refractometer, ophthalmic\nOne unit per package",
      "code_info": "Lot Code: \" Product Code: HKO\n\" Version or Model: 901029\n\" Catalog Number: VS100\n\" Company Name: WELCH ALLYN, INC.\n\" Primary DI Number: 00732094214154\n\" Packaging DI Number: 00732094212228\n\" Device Description: VS100 UDI BASE UNIT\n\" Software version: 3.2.0.1\n\" Serial Numbers: Refer to attached Affected Product Table",
      "firm_fei_number": "1417572",
      "recalling_firm": "Baxter Healthcare Corporation",
      "address_1": "1 Baxter Pkwy",
      "city": "Deerfield",
      "state": "IL",
      "postal_code": "60015-4625",
      "additional_info_contact": "Center for One Baxter\n1-800-4229837",
      "reason_for_recall": "Display screen may unintentionally flicker due to a software issue. Exposure to flickering lights may induce photosensitive seizure activity in susceptible individuals.",
      "root_cause_description": "Device Design",
      "action": "On February 18, 2026, the firm notified consignees via Urgent Medical Device Recall letters.\n\nUsers were instructed to immediately locate, isolate, and stop using the listed affected products. Customers should contact Baxter Technical Support to arrange for the return and correction of their impacted device. Baxter may provide a loaner device upon request while your device is being upgraded and serviced.\n\nDistributors should return unopened products in inventory for credit. If affected product was further distributed, the distributor should conduct a consumer-level recall.",
      "product_quantity": "59",
      "distribution_pattern": "Worldwide - US Nationwide distribution in the states of AZ, CO, IL, IN, KS, MA, NE, NJ, NM, NY, PA, SC, TX, VA and the countries of Colombia and India.",
      "openfda": {
        "k_number": [
          "K901513",
          "K942242",
          "K802029",
          "K861066",
          "K843042",
          "K871611",
          "K890559",
          "K812063",
          "K820877",
          "K924790",
          "K925304",
          "K812896",
          "K901583",
          "K882287",
          "K031831",
          "K940516",
          "K861065",
          "K802183",
          "K902500",
          "K904828",
          "K924778",
          "K951179",
          "K862521",
          "K883200",
          "K882191",
          "K861062",
          "K924741",
          "K771914",
          "K801906",
          "K000327",
          "K831083",
          "K781014",
          "K841861",
          "K802958",
          "K945959"
        ],
        "device_name": "Refractometer, Ophthalmic",
        "medical_specialty_description": "Ophthalmic",
        "regulation_number": "886.1760",
        "device_class": "1",
        "registration_number": [
          "3007584446",
          "3010774780",
          "",
          "9710098",
          "3008729548",
          "3038287496",
          "3010227033",
          "3004167900",
          "3010363281",
          "3005755367",
          "3007913988",
          "3013148497",
          "3006087789",
          "3007343325",
          "3005785090",
          "3023983572",
          "3038614464",
          "3012540196",
          "1000181430",
          "3014273520",
          "3004438257",
          "3005771344",
          "1419226",
          "3004026651",
          "3009756596",
          "3045062165",
          "3008058416",
          "3003829667",
          "3013436538",
          "3017657497",
          "3033882233",
          "1836161",
          "3027396409",
          "2936921",
          "3004095901",
          "3017045523",
          "3003851947",
          "3009132348",
          "2242863",
          "3016009612",
          "3009173773",
          "3008044461",
          "9617474",
          "3003951061",
          "8030433",
          "3030089778",
          "9616199",
          "3008044477",
          "3015972897",
          "3009515444",
          "3010610157",
          "3043729153",
          "2031962",
          "3011253868",
          "3009275598",
          "3002807715",
          "3013003882",
          "1319721",
          "3013846070",
          "3013158193",
          "3003984265",
          "1054713",
          "8030392",
          "3038356864",
          "9614730",
          "3010539401",
          "1316463",
          "3021343245",
          "3013403214",
          "3013575858",
          "3004441848",
          "3003771740",
          "9615030",
          "3011898560",
          "3012162565",
          "3011977270",
          "9614661"
        ],
        "fei_number": [
          "3007584446",
          "3010774780",
          "3013003882",
          "",
          "3045062165",
          "1000582291",
          "3009173773",
          "3008044461",
          "1000159913",
          "3002398337",
          "3002957101",
          "3008729548",
          "3008058416",
          "3038287496",
          "3010227033",
          "3003829667",
          "3013436538",
          "3017657497",
          "3013846070",
          "3002680900",
          "1000114111",
          "3004167900",
          "3010363281",
          "3013158193",
          "3003768492",
          "3005755367",
          "3033882233",
          "3007913988",
          "3013148497",
          "3006087789",
          "3002445546",
          "3005785090",
          "3003984265",
          "3007343325",
          "3001362763",
          "3027396409",
          "3038356864",
          "2936921",
          "3003951061",
          "3023983572",
          "3004095901",
          "3010539401",
          "3030089778",
          "3017045523",
          "3008044477",
          "3038614464",
          "3003851947",
          "3002750084",
          "3012540196",
          "3009132348",
          "1316463",
          "3015972897",
          "3013403214",
          "1000181430",
          "3021343245",
          "3009515444",
          "3014273520",
          "3010610157",
          "3004438257",
          "3013575858",
          "3043729153",
          "3004441848",
          "3005771344",
          "1419226",
          "2242863",
          "3003771740",
          "3011253868",
          "3011898560",
          "3012162565",
          "3009275598",
          "3011977270",
          "3016009612",
          "3009756596",
          "1000175127",
          "3002807715",
          "3009662620"
        ]
      }
    }
  ]
}