{
  "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": "2026-09-20",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 2
    }
  },
  "results": [
    {
      "cfres_id": "199452",
      "product_res_number": "Z-1475-2023",
      "event_date_initiated": "2023-03-17",
      "event_date_posted": "2023-04-28",
      "recall_status": "Open, Classified",
      "res_event_number": "92040",
      "product_code": "FTA",
      "product_description": "Steris Lighting and Visualization Systems, Sterile Light Handle Cover (LB53)- Surgical light handle covers, including disposable surgical light handle covers are designed to fit over surgical light handles for sterile surgeon control.\n\nREF: LB53",
      "code_info": "GTIN number: 00724995150136\nLot Numbers:\n9604187 / 9604187A\n9604188 / 9604188A\n9604189 / 9604189A\n9604190 / 9604190A\n9604191 / 9604191A\n9799082 / 9799082A\n9799083 / 9799083A\n9799084 / 9799084A\n9799085 / 9799085A\n9799086 / 9799086A\n9799087 / 9799087A\n9799088 / 9799088A\n9799089 / 9799089A\n9799090 / 9799090A\n9799091 / 9799091A\n9799092 / 9799092A\n9799093 / 9799093A\n9799094 / 9799094A\n9799095 / 9799095A\n9799096 / 9799096A\n9799097 / 9799097A\n9799098 / 9799098A\n9799099 / 9799099A\n9799100 / 9799100A\n9799101 / 9799101A\n9799102 / 9799102A\n9799103 / 9799103A\n9799104 / 9799104A\n9799105 / 9799105A\n9799106 / 9799106A\n9799107 / 9799107A\n9799108 / 9799108A",
      "firm_fei_number": "1527821",
      "recalling_firm": "Steris Corporation",
      "address_1": "5960 Heisley Rd",
      "city": "Mentor",
      "state": "OH",
      "postal_code": "44060-1834",
      "additional_info_contact": "SAME\n440-392-7601",
      "reason_for_recall": "Light handle covers may separate from the light handle (detach and fall off) during use, this could result in a procedure delay and/or impact the sterile field which could result in an injury to the patient",
      "root_cause_description": "Under Investigation by firm",
      "action": "Steris issued Urgent Medical Device Recall Letter on 3/17/23 via FedEx. Letter states reason for recall, health risk and action to take:\n1. Please immediately inspect your on-hand inventory for product affected by this recall. For the full list of lots affected by this recall, please reference Attachment A to this letter.\n2. Please complete the Medical Device Recall Response Form included with this letter and destroy any remaining product in your inventory. If product was transferred to any other entities within your organization, please forward this recall notice accordingly. STERIS will coordinate shipment of replacement product upon receipt of the completed Recall Response Form.\n3. Return the completed Recall Response Form via email to: Regulatory_Compliance@STERIS.com or via fax to (440) 392-8963.\nUsers are reminded to report any adverse events via FDA s MedWatch Database should an event occur.  If you have questions regarding this recall, please contact STERIS Customer Service at 1-800-548-4873, or email the RMA Team at HealthcareRMA@STERIS.com.",
      "product_quantity": "1,358,520 covers",
      "distribution_pattern": "Worldwide - US Nationwide distribution including Puerto Rico and the countries of Canada, Australia.",
      "openfda": {
        "k_number": [
          "K133413",
          "K935102",
          "K901154",
          "K915068",
          "K890867",
          "K133554",
          "K112133",
          "K890539",
          "K862010",
          "K871034",
          "K882132",
          "K051505",
          "K993089",
          "K053321",
          "K020304",
          "K890866",
          "K150532",
          "K894397",
          "K023704",
          "K102791",
          "K780162",
          "K954940",
          "K142386",
          "K020640",
          "K810292",
          "K081698"
        ],
        "registration_number": [
          "3012811961",
          "9710055",
          "1047429",
          "3000268902",
          "3043140693",
          "2027467",
          "3030446844",
          "3008776287",
          "1836161",
          "1526534",
          "3001124136",
          "3009061550",
          "3020468145",
          "1030451",
          "3008583452",
          "3005739529",
          "3045058049",
          "3001650535",
          "3012165496",
          "3012990631",
          "3021013122",
          "1066635",
          "1058584",
          "3004111573",
          "3018811167",
          "2020550",
          "3006617885",
          "1043572",
          "3019252669",
          "3017124433",
          "3022320321",
          "3014342096",
          "3007681502",
          "3018503755",
          "3016659819",
          "3019878714",
          "3006437518",
          "3030516433",
          "3014342658",
          "3035642068",
          "3004001706",
          "3010041511",
          "3013557562",
          "9610617",
          "3023272778",
          "3004091527",
          "3012706495",
          "2530138",
          "3013429260",
          "3006223081",
          "3031563141",
          "1018470",
          "3004050971",
          "9614434",
          "3005245797",
          "3015058854",
          "3010288357",
          "1060680",
          "3004911384",
          "3010305275",
          "1055236",
          "9611500",
          "3017636737",
          "1057404",
          "2320762",
          "1054241",
          "3021562244",
          "3011137372",
          "1417592",
          "3010202439",
          "1061124",
          "8043817",
          "3021970868",
          "3010380518",
          "3022954003",
          "3015532217",
          "1423537",
          "3013429557",
          "3012137049",
          "1825014",
          "3006542380",
          "3019257308",
          "8030128",
          "3010676465",
          "1450758",
          "9616088",
          "1047843",
          "1420032",
          "1123137",
          "1043214",
          "3015542695",
          "3006536657",
          "3004605321",
          "3010707607"
        ],
        "fei_number": [
          "3012811961",
          "1000512168",
          "3002808273",
          "1047429",
          "3000268902",
          "3043140693",
          "2027467",
          "3030446844",
          "1000221205",
          "3008776287",
          "1526534",
          "3001124136",
          "3009061550",
          "3020468145",
          "1030451",
          "3008583452",
          "3005747797",
          "3005739529",
          "3045058049",
          "3001650535",
          "3012165496",
          "1000208576",
          "3012990631",
          "3021013122",
          "3004111573",
          "3003094575",
          "3018811167",
          "2020550",
          "1000123180",
          "3006617885",
          "3003184737",
          "1000112877",
          "1043572",
          "1000219637",
          "3019252669",
          "3017124433",
          "3022320321",
          "3014342096",
          "3007681502",
          "3018503755",
          "3016659819",
          "1000112968",
          "3019878714",
          "3006437518",
          "3030516433",
          "3014342658",
          "3035642068",
          "3004001706",
          "3010041511",
          "3013557562",
          "3023272778",
          "3004091527",
          "3012706495",
          "3006223081",
          "3031563141",
          "3003040625",
          "1018470",
          "3004050971",
          "3005245797",
          "3015058854",
          "3002465150",
          "3001236905",
          "3006118668",
          "3010288357",
          "3004911384",
          "3010305275",
          "3007475226",
          "1000208624",
          "3017636737",
          "3001104093",
          "1000138386",
          "3002808268",
          "3021562244",
          "1417592",
          "3021970868",
          "3010380518",
          "3015532217",
          "3022954003",
          "3013429557",
          "3012137049",
          "1825014",
          "3002750084",
          "3006542380",
          "3019257308",
          "3010676465",
          "3002902735",
          "1450758",
          "1047843",
          "1420032",
          "1043214",
          "3015542695",
          "3006536657",
          "3004605321",
          "3010707607"
        ],
        "device_name": "Light, Surgical, Accessories",
        "medical_specialty_description": "General, Plastic Surgery",
        "regulation_number": "878.4580",
        "device_class": "2"
      }
    }
  ]
}