{
  "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": 2
    }
  },
  "results": [
    {
      "cfres_id": "220992",
      "product_res_number": "Z-2673-2026",
      "event_date_initiated": "2026-06-09",
      "event_date_posted": "2026-07-02",
      "recall_status": "Open, Classified",
      "res_event_number": "99186",
      "product_code": "KCY",
      "product_description": "Brand Name: Sterile Tourniquet Hoses\nProduct Name: A.T.S 4000 TS Tourniquet Systems Dual Hose with CPC Connectors\nModel/Catalog Number: 60-1812-101-00\nSoftware Version: N/A\nProduct Description: Dual Sterile Extension Hose with PLC Connector\nComponent: N/A",
      "code_info": "Lot Code: Model No. 60-1812-101-00 ; Case (20-pack) UDI (01)00889024381162(17)271125(10)78938271 ; Box (10-Pack) UDI  (01)00889024378469(17)271125(10)78938271 ; Individual UDI (01)00889024367173(17)271125(10)78938271 ; Lot Number 78938271\nModel No. 60-1812-101-00 ; Case (20-pack) UDI (01)00889024381162(17)271126(10)78938272 ; Box (10-Pack) UDI  (01)00889024378469(17)271126(10)78938272 ; Individual UDI (01)00889024367173(17)271126(10)78938272 ; Lot Number 78938272\nModel No. 60-1812-101-00 ; Case (20-pack) UDI (01)00889024381162(17)271127(10)78938273 ; Box (10-Pack) UDI  (01)00889024378469(17)271127(10)78938273 ; Individual UDI (01)00889024367173(17)271127(10)78938273 ; Lot Number 78938273\nModel No. 60-1812-101-00 ; Case (20-pack) UDI (01)00889024381162(17)280206(10)80555986 ; Box (10-Pack) UDI  (01)00889024378469(17)280206(10)80555986 ; Individual UDI (01)00889024367173(17)280206(10)80555986 ; Lot Number 80555986\nModel No. 60-1812-101-00 ; Case (20-pack) UDI (01)00889024381162(17)280102(10)80555987 ; Box (10-Pack) UDI  (01)00889024378469(17)280102(10)80555987 ; Individual UDI (01)00889024367173(17)280102(10)80555987 ; Lot Number 80555987\nModel No. 60-1812-101-00 ; Case (20-pack) UDI (01)00889024381162(17)280210(10)80555988 ; Box (10-Pack) UDI  (01)00889024378469(17)280210(10)80555988 ; Individual UDI (01)00889024367173(17)280210(10)80555988 ; Lot Number 80555988\nModel No. 60-1812-101-00 ; Case (20-pack) UDI (01)00889024381162(17)280214(10)80555989 ; Box (10-Pack) UDI  (01)00889024378469(17)280214(10)80555989 ; Individual UDI (01)00889024367173(17)280214(10)80555989 ; Lot Number 80555989\nModel No. 60-1812-101-00 ; Case (20-pack) UDI (01)00889024381162(17)280217(10)80555990 ; Box (10-Pack) UDI  (01)00889024378469(17)280217(10)80555990 ; Individual UDI (01)00889024367173(17)280217(10)80555990 ; Lot Number 80555990\nModel No. 60-1812-101-00 ; Case (20-pack) UDI (01)00889024381162(17)280225(10)80568849 ; Box (10-Pack) UDI  (01)00889024378469(17)280225(10)80568849 ; Individual UDI (01)00889024367173(17)280225(10)80568849 ; Lot Number 80568849\nModel No. 60-1812-101-00 ; Case (20-pack) UDI (01)00889024381162(17)280409(10)82010858 ; Box (10-Pack) UDI  (01)00889024378469(17)280409(10)82010858 ; Individual UDI (01)00889024367173(17)280409(10)82010858 ; Lot Number 82010858\nModel No. 60-1812-101-00 ; Case (20-pack) UDI (01)00889024381162(17)280403(10)82010859 ; Box (10-Pack) UDI  (01)00889024378469(17)280403(10)82010859 ; Individual UDI (01)00889024367173(17)280403(10)82010859 ; Lot Number 82010859\nModel No. 60-1812-101-00 ; Case (20-pack) UDI (01)00889024381162(17)280415(10)82196691 ; Box (10-Pack) UDI  (01)00889024378469(17)280415(10)82196691 ; Individual UDI (01)00889024367173(17)280415(10)82196691 ; Lot Number 82196691\nModel No. 60-1812-101-00 ; Case (20-pack) UDI (01)00889024381162(17)280419(10)82196692 ; Box (10-Pack) UDI  (01)00889024378469(17)280419(10)82196692 ; Individual UDI (01)00889024367173(17)280419(10)82196692 ; Lot Number 82196692\nModel No. 60-1812-101-00 ; Case (20-pack) UDI (01)00889024381162(17)280423(10)82331021 ; Box (10-Pack) UDI  (01)00889024378469(17)280423(10)82331021 ; Individual UDI (01)00889024367173(17)280423(10)82331021 ; Lot Number 82331021\nModel No. 60-1812-101-00 ; Case (20-pack) UDI (01)00889024381162(17)280427(10)82331022 ; Box (10-Pack) UDI  (01)00889024378469(17)280427(10)82331022 ; Individual UDI (01)00889024367173(17)280427(10)82331022 ; Lot Number 82331022\nModel No. 60-1812-101-00 ; Case (20-pack) UDI (01)00889024381162(17)280501(10)82418900 ; Box (10-Pack) UDI  (01)00889024378469(17)280501(10)82418900 ; Individual UDI (01)00889024367173(17)280501(10)82418900 ; Lot Number 82418900\nModel No. 60-1812-101-00 ; Case (20-pack) UDI (01)00889024381162(17)280507(10)82418901 ; Box (10-Pack) UDI  (01)00889024378469(17)280507(10)82418901 ; Individual UDI (01)00889024367173(17)280507(10)82418901 ; Lot Number 82418901\nModel No. 60-1812-101-00 ; Case (20-pack) UDI (01)00889024381162(17)280513(10)82639501 ; Box (10-Pack) UDI  (01)00889024378469(17)280513(10)82639501 ; Individual UDI (01)00889024367173(17)280513(10)82639501 ; Lot Number 82639501\nModel No. 60-1812-101-00 ; Case (20-pack) UDI (01)00889024381162(17)280516(10)82761025 ; Box (10-Pack) UDI  (01)00889024378469(17)280516(10)82761025 ; Individual UDI (01)00889024367173(17)280516(10)82761025 ; Lot Number 82761025\nModel No. 60-1812-101-00 ; Case (20-pack) UDI (01)00889024381162(17)280529(10)83343102 ; Box (10-Pack) UDI  (01)00889024378469(17)280529(10)83343102 ; Individual UDI (01)00889024367173(17)280529(10)83343102 ; Lot Number 83343102\nModel No. 60-1812-101-00 ; Case (20-pack) UDI (01)00889024381162(17)280820(10)84859541 ; Box (10-Pack) UDI  (01)00889024378469(17)280820(10)84859541 ; Individual UDI (01)00889024367173(17)280820(10)84859541 ; Lot Number 84859541\nModel No. 60-1812-101-00 ; Case (20-pack) UDI (01)00889024381162(17)280902(10)84859542 ; Box (10-Pack) UDI  (01)00889024378469(17)280902(10)84859542 ; Individual UDI (01)00889024367173(17)280902(10)84859542 ; Lot Number 84859542\nModel No. 60-1812-101-00 ; Case (20-pack) UDI (01)00889024381162(17)281112(10)86156905 ; Box (10-Pack) UDI  (01)00889024378469(17)281112(10)86156905 ; Individual UDI (01)00889024367173(17)281112(10)86156905 ; Lot Number 86156905",
      "firm_fei_number": "1526350",
      "recalling_firm": "Zimmer Surgical Inc",
      "address_1": "200 W Ohio Ave",
      "city": "Dover",
      "state": "OH",
      "postal_code": "44622-9642",
      "additional_info_contact": "411 Technical Services\n800-6136131",
      "reason_for_recall": "Potential sterility breach in sealing area of sterile pouch. If used, issue may result in moderate localized infection. If discovered prior to use, may result in clinically insignificant extension of surgery to find another readily available device.",
      "root_cause_description": "Under Investigation by firm",
      "action": "On June 8, 2026, the firm began notifying consignees titled \"URGENT MEDICAL DEVICE RECALL.\"\n\nCustomers were instructed to locate and quarantine affected product in their inventory. Customers may either return the affected product, or a Zimmer Biomet sales representative may remove and return the affected product on the customer's behalf.\n\nIf the product has been further distributed, the distributor should notify downstream customers and accounts of the recall. All customers should ensure that affected personnel are aware of the recall.\n\nThis recall is related to prior recall RES 98665, conducted to remove Mixing Bowl and Spatula due to similar issues with seal integrity.",
      "product_quantity": "45160",
      "distribution_pattern": "Worldwide distribution - US Nationwide and the countries of Canada and EMEA.",
      "openfda": {
        "k_number": [
          "K841558",
          "K840206",
          "K860095",
          "K853802",
          "K202919",
          "K162365",
          "K813231",
          "K942303",
          "K880020",
          "K945167",
          "K123553",
          "K910449",
          "K860463",
          "K890014",
          "K112874",
          "K910512",
          "K791759",
          "K955552",
          "K924273",
          "K071140",
          "K925033",
          "K953953",
          "K842963",
          "K870784",
          "K780988",
          "K012632",
          "K940615",
          "K954201",
          "K933994",
          "K954103",
          "K871982",
          "K952038",
          "K900104",
          "K050411"
        ],
        "registration_number": [
          "3015225571",
          "3011185837",
          "9680215",
          "9680579",
          "3005173255",
          "3005621729",
          "3012494290",
          "3011277660",
          "3006535925",
          "3015542154",
          "3033773618",
          "3003244954",
          "3006975482",
          "3007478714",
          "3010883047",
          "3012421607",
          "3038700849",
          "9611559",
          "2528981",
          "1421307",
          "2648666",
          "1058584",
          "3045058049",
          "3015967359",
          "2032098",
          "3012276218",
          "1043214",
          "1423537",
          "3006950086",
          "3011683674",
          "1722028",
          "2184171",
          "3013730933",
          "3007997036",
          "3010273872",
          "3033589330",
          "1650907",
          "3016764932",
          "3014313732",
          "3002907620",
          "3030516433",
          "1822565",
          "3004727093",
          "1720929",
          "9681444",
          "3014126909",
          "1018470",
          "3034520",
          "3010759902",
          "3008264111",
          "1526350",
          "3015309643",
          "3004824601",
          "3008381116",
          "9613910",
          "8040278",
          "1721504",
          "3020163307",
          "1220351",
          "1528668",
          "3004905643",
          "3006703573",
          "3015207155",
          "3025434447",
          "3014023545",
          "3013783488",
          "3033511104",
          "3023228837",
          "1818910",
          "3009039068",
          "3030733800",
          "3016965559",
          "9611283",
          "3010410654",
          "8010939",
          "8010482",
          "3009350690",
          "3006128321",
          "3031700059",
          "2650143",
          "3010595915",
          "1921846",
          "3015280549",
          "3010291427",
          "3009605245",
          "3014739961",
          "3009056984",
          "3016445580",
          "3012536737",
          "3011642792",
          "1048735",
          "3010123014",
          "2320762",
          "3010190204",
          "3031887985",
          "1649518",
          "2029275",
          "3005698350",
          "3016678045",
          "3016950436",
          "1422634",
          "3030153385",
          "3015495690",
          "3032391",
          "3004116008",
          "3013846070",
          "2011171",
          "3014830562"
        ],
        "fei_number": [
          "3015225571",
          "3011185837",
          "1000117351",
          "3005173255",
          "2648209",
          "3005621729",
          "3002808440",
          "3012599796",
          "1000203464",
          "3012494290",
          "3011277660",
          "3006535925",
          "3015542154",
          "3033773618",
          "3003244954",
          "3006975482",
          "3007478714",
          "3002299608",
          "3012421607",
          "3038700849",
          "3001236905",
          "2528981",
          "3001084824",
          "1421307",
          "2648666",
          "3045058049",
          "3015967359",
          "3002806816",
          "1000306431",
          "3003040625",
          "3012276218",
          "3003350313",
          "3003255513",
          "1043214",
          "3006950086",
          "3011683674",
          "3013730933",
          "3007997036",
          "3033589330",
          "3010273872",
          "3016764932",
          "3014313732",
          "3002907620",
          "3030516433",
          "3004727093",
          "1720929",
          "3014126909",
          "1018470",
          "3010759902",
          "3003748933",
          "3008264111",
          "1526350",
          "3015309643",
          "1000220733",
          "3004824601",
          "3008381116",
          "1000139815",
          "1721504",
          "3020163307",
          "1220351",
          "3004905643",
          "3006703573",
          "3015207155",
          "3025434447",
          "1000219637",
          "3014023545",
          "3013783488",
          "3033511104",
          "3023228837",
          "1818910",
          "3009039068",
          "3030733800",
          "3002681132",
          "3016965559",
          "3010410654",
          "3001236277",
          "1000292048",
          "3009350690",
          "3006128321",
          "3031700059",
          "3010595915",
          "1000136409",
          "1921846",
          "3015280549",
          "3010291427",
          "3009605245",
          "3014739961",
          "3009056984",
          "3016445580",
          "3012536737",
          "3011642792",
          "1048735",
          "3010123014",
          "1000514656",
          "3004574120",
          "3003058448",
          "3010190204",
          "3031887985",
          "3004216008",
          "3005698350",
          "3016678045",
          "3016950436",
          "3030153385",
          "3015495690",
          "3004116008",
          "3013846070",
          "2011171",
          "3014830562"
        ],
        "device_name": "Tourniquet, Pneumatic",
        "medical_specialty_description": "General, Plastic Surgery",
        "regulation_number": "878.5910",
        "device_class": "1"
      }
    }
  ]
}