{
  "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": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "cfres_id": "196465",
      "product_res_number": "Z-0245-2023",
      "event_date_initiated": "2022-10-24",
      "event_date_posted": "2022-11-17",
      "recall_status": "Open, Classified",
      "res_event_number": "91000",
      "product_code": "FNG",
      "product_description": "Infection Control (IC) Lifting Strap used with the following Cirrus and Pinnacle Ceiling Lifts: Cirrus 450, Cirrus 600, Cirrus 700, Cirrus 750, and Pinnacle 1000",
      "code_info": "UDI-DI 00817956021 (not yet uploaded to GUDID)",
      "firm_fei_number": "3008406502",
      "recalling_firm": "Tollos",
      "address_1": "8 Easter Ct Ste J 8 Easter Ct",
      "address_2": "Ste J",
      "city": "Owings Mills",
      "state": "MD",
      "postal_code": "21117-3294",
      "additional_info_contact": "Theresa Stewart\n410-3631515",
      "reason_for_recall": "Two customers reported four incidents in which the lifting strap broke while lifting a patient. If the IC strap fails during use, the patient may fall causing injury to them or the caregiver(s).",
      "root_cause_description": "Equipment maintenance",
      "action": "On October 24, 2022, the firm notified affected customers via Urgent Medical Device Correction letters.\n\nThe firm is updating their operator's manual and service manual with instructions to inspect the IC straps prior to use, along with photo illustrations of lifting straps demonstrating wear/damage conditions that indicate replacement must be performed.\n\nAccess complete Operator s & Service Manuals on the web at www.tollos.com/service-bulletins.\n\nTollos can be contacted by e-mail at service@tollos.com.",
      "product_quantity": "1273 US; 70 OUS",
      "distribution_pattern": "Worldwide - US Nationwide distribution and the countries of Canada and United Arab Emirates.",
      "openfda": {
        "k_number": [
          "K811900",
          "K844872",
          "K802780",
          "K903723",
          "K905414",
          "K844871",
          "K811901",
          "K896848",
          "K854120",
          "K926411",
          "K885270",
          "K940872",
          "K854058",
          "K912769",
          "K895677",
          "K862147",
          "K801933",
          "K935351",
          "K862146",
          "K121287",
          "K041503"
        ],
        "device_name": "Lift, Patient, Ac-Powered",
        "medical_specialty_description": "General Hospital",
        "regulation_number": "880.5500",
        "device_class": "2",
        "registration_number": [
          "3006891315",
          "3009567010",
          "3016678950",
          "3036834029",
          "9616086",
          "3011806255",
          "3009265647",
          "3014523858",
          "3016746538",
          "3009155756",
          "3017375560",
          "1225263",
          "9681454",
          "3008771621",
          "3030447508",
          "3015526491",
          "3018115441",
          "3006440543",
          "3030681105",
          "3033882216",
          "1000252066",
          "3007031002",
          "1058069",
          "3004168774",
          "3014739961",
          "3019576863",
          "3009407891",
          "3013875443",
          "3012781455",
          "3033506545",
          "9617427",
          "9710603",
          "3004024088",
          "3006554924",
          "3021632322",
          "2531468",
          "3017264244",
          "3009327812",
          "3011191255",
          "1062191",
          "3008351005",
          "3021966508",
          "3006206434",
          "3003063250",
          "3021374638",
          "3016969129",
          "3009157571",
          "3007441619",
          "2030732",
          "3013354832",
          "3017079526",
          "2428983",
          "3043654660",
          "3010394125",
          "3036978609",
          "3017171467",
          "3007048057",
          "3035641505"
        ],
        "fei_number": [
          "3006891315",
          "3009567010",
          "3016678950",
          "3002572935",
          "3036834029",
          "3011806255",
          "3009265647",
          "3014523858",
          "3016746538",
          "3009155756",
          "3001600982",
          "3017375560",
          "3000719717",
          "3008771621",
          "3030447508",
          "3002615774",
          "3000204953",
          "3015526491",
          "3018115441",
          "3006440543",
          "3030681105",
          "3006076154",
          "3033882216",
          "3003513125",
          "1000252066",
          "3007031002",
          "3004168774",
          "3014739961",
          "3019576863",
          "3009407891",
          "3013875443",
          "3012781455",
          "3033506545",
          "2427360",
          "3004024088",
          "3006554924",
          "3021632322",
          "3000719543",
          "3017264244",
          "3009327812",
          "3011191255",
          "3008351005",
          "1000221992",
          "3021966508",
          "3006206434",
          "3003063250",
          "3021374638",
          "3016969129",
          "3009157571",
          "3007441619",
          "3017079526",
          "3013354832",
          "3043654660",
          "3010394125",
          "3036978609",
          "3017171467",
          "3007048057",
          "3035641505"
        ]
      }
    }
  ]
}