{
  "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": "2026-09-12",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 2
    }
  },
  "results": [
    {
      "cfres_id": "193159",
      "product_res_number": "Z-1126-2022",
      "event_date_initiated": "2022-04-11",
      "event_date_created": "2022-05-24",
      "recall_status": "Open, Classified",
      "res_event_number": "90014",
      "product_code": "BYD",
      "product_description": "(1) Gibeck Humid-Vent 2S Flex DC, Product #17731, sterile;\n(2) Gibeck Humid-Vent 2S Flex DC, Product #17732, non-sterile;\n(3) Gibeck Humid-Vent Filter Compact S with Smooth-Flo/Swivel, Product #19061, sterile;\n(4) Gibeck Humid-Vent Filter Compact S with Smooth-Flo/Swivel, Product #19062, non-sterile; and \n(5) Gibeck Humid-Vent Filter Compact S with Flex Tube, Product #19812, non-sterile.",
      "code_info": "Batch and UDI numbers:\n\n(1) Product 17731:\n\nKMH21C0130 (01)04026704347919(17)260228(10)KMH21C0130;\nKMH21C0162\t(01)04026704347919(17)260228(10)KMH21C0162;\nKMH21C0262\t(01)04026704347919(17)260228(10)KMH21C0262;\nKMH21C0265\t(01)04026704347919(17)260228(10)KMH21C0265;\nKMH21E0077\t(01)04026704347919(17)260428(10)KMH21E0077;\nKMH21F0231\t(01)04026704347919(17)260528(10)KMH21F0231;\nKMH21F0276\t(01)04026704347919(17)260528(10)KMH21F0276;\nKMH21G0428\t(01)04026704347919(17)260628(10)KMH21G0428;\nKMH21H0142\t(01)04026704347919(17)260728(10)KMH21H0142;\nKMH21L0020\t(01)04026704347919(17)261028(10)KMH21L0020; and\nKMH22A0068\t(01)04026704347919(17)261228(10)KMH22A0068.\n\n(2) Product 17732:\n\nKMZ21G0733\t(01)04026704347926(17)260628(10)KMZ21G0733;\nKMZ21G0742\t(01)04026704347926(17)260628(10)KMZ21G0742;\nKMZ21G0989\t(01)04026704347926(17)260628(10)KMZ21G0989;\nKMZ21G1049\t(01)04026704347926(17)260628(10)KMZ21G1049;\nKMZ21K0159\t(01)04026704347926(17)260928(10)KMZ21K0159;\nKMZ21K0160\t(01)04026704347926(17)260928(10)KMZ21K0160;\nKMZ21K0275\t(01)04026704347926(17)260928(10)KMZ21K0275;\nKMZ21K0451\t(01)04026704347926(17)260928(10)KMZ21K0451;\nKMZ21L0103\t(01)04026704347926(17)261028(10)KMZ21L0103;\nKMZ21L0602\t(01)04026704347926(17)261028(10)KMZ21L0602;\nKMZ21C0125\t(01)04026704347926(17)260228(10)KMZ21C0125;\nKMZ21C0235\t(01)04026704347926(17)260228(10)KMZ21C0235;\nKMZ21C0300\t(01)04026704347926(17)260228(10)KMZ21C0300;\nKMZ21C0347\t(01)04026704347926(17)260228(10)KMZ21C0347;\nKMZ21C0351\t(01)04026704347926(17)260228(10)KMZ21C0351;\nKMZ21C0475\t(01)04026704347926(17)260228(10)KMZ21C0475;\nKMZ21C0609\t(01)04026704347926(17)260228(10)KMZ21C0609;\nKMZ21C0851\t(01)04026704347926(17)260228(10)KMZ21C0851;\nKMZ21C0863\t(01)04026704347926(17)260228(10)KMZ21C0863;\nKMZ21C1154\t(01)04026704347926(17)260228(10)KMZ21C1154;\nKMZ21C1342\t(01)04026704347926(17)260228(10)KMZ21C1342;\nKMZ21D0016\t(01)04026704347926(17)260328(10)KMZ21D0016;\nKMZ21D0200\t(01)04026704347926(17)260328(10)KMZ21D0200;\nKMZ21D0311\t(01)04026704347926(17)260328(10)KMZ21D0311;\nKMZ21D0357\t(01)04026704347926(17)260328(10)KMZ21D0357;\nKMZ21D0404\t(01)04026704347926(17)260328(10)KMZ21D0404;\nKMZ21D0481\t(01)04026704347926(17)260328(10)KMZ21D0481;\nKMZ21D0510\t(01)04026704347926(17)260328(10)KMZ21D0510;\nKMZ21E0096\t(01)04026704347926(17)260428(10)KMZ21E0096;\nKMZ21F0475\t(01)04026704347926(17)260528(10)KMZ21F0475;\nKMZ21F0483\t(01)04026704347926(17)260528(10)KMZ21F0483;\nKMZ21F0484\t(01)04026704347926(17)260528(10)KMZ21F0484; and\nKMZ21F0873\t(01)04026704347926(17)260528(10)KMZ21F0873.\n\n(3) Product 19061:\n\nKMH21F0418\t(01)04026704388387(17)260528(10)KMH21F0418;\nKMH21G0357\t(01)04026704388387(17)260628(10)KMH21G0357;\nKMH21H0060\t(01)04026704388387(17)260728(10)KMH21H0060;\nKMH21H0062\t(01)04026704388387(17)260728(10)KMH21H0062;\nKMH21H0252\t(01)04026704388387(17)260728(10)KMH21H0252;\nKMH21J0021\t(01)04026704388387(17)260828(10)KMH21J0021;\nKMH21J0260\t(01)04026704388387(17)260828(10)KMH21J0260;\nKMH21K0159\t(01)04026704388387(17)260928(10)KMH21K0159;\nKMH21K0375\t(01)04026704388387(17)260928(10)KMH21K0375;\nKMH21L0139\t(01)04026704388387(17)261028(10)KMH21L0139;\nKMH21C0188\t(01)04026704388387(17)260228(10)KMH21C0188;\nKMH21C0191\t(01)04026704388387(17)260228(10)KMH21C0191;\nKMH21C0194\t(01)04026704388387(17)260228(10)KMH21C0194;\nKMH21C0280\t(01)04026704388387(17)260228(10)KMH21C0280;\nKMH21C0388\t(01)04026704388387(17)260228(10)KMH21C0388;\nKMH21D0094\t(01)04026704388387(17)260328(10)KMH21D0094;\nKMH21D0289\t(01)04026704388387(17)260328(10)KMH21D0289;\nKMH21D0290\t(01)04026704388387(17)260328(10)KMH21D0290;\nKMH21E0240\t(01)04026704388387(17)260428(10)KMH21E0240; and\nKMH21F0155\t(01)04026704388387(17)260528(10)KMH21F0155.\n\n(4) Product 19062:\n\nKMZ21C0425\t(01)04026704388394(17)260228(10)KMZ21C0425;\nKMZ21C0923\t(01)04026704388394(17)260228(10)KMZ21C0923; and\nKMZ21F0379\t(01)04026704388394(17)260528(10)KMZ21F0379.\n\n(5) Product 19812:\n\nKMZ21G0681\t(01)04026704388721(17)260628(10)KMZ21G0681;\nKMZ21G0710\t(01)04026704388721(17)260628(10)KMZ21G0710;\nKMZ21K0459\t(01)04026704388721(17)260928(10)KMZ21K0459;\nKMZ21C0141\t(01)04026704388721(17)260228(10)KMZ21C0141;\nKMZ21C0948\t(01)04026704388721(17)260228(10)KMZ21C0948;\nKMZ21F0361\t(01)04026704388721(17)260528(10)KMZ21F0361; and \nKMZ21F0627\t(01)04026704388721(17)260528(10)KMZ21F0627.",
      "firm_fei_number": "3005747797",
      "recalling_firm": "TELEFLEX MEDICAL INC",
      "address_1": "3015 Carrington Mill Blvd",
      "city": "Morrisville",
      "state": "NC",
      "postal_code": "27560-5437",
      "reason_for_recall": "Reports received of torn corrugated breathing tubes.",
      "root_cause_description": "Device Design",
      "action": "The recalling firm issued letters dated April 2022 on 4/11/2022 via FedEx 2-day mail.   The letter described the issue, the immediate actions required including the hazards involved, and provided specific actions to be taken and instructions to be followed by the medical facilities or the distributors.\n\nFor the medical facilities, they are to cease use and distribution of the impacted product and immediately quarantine it.  If the product is in inventory, indicate the information on the Acknowledgment Form and FAX it to Customer Service or email it to the firm.  A customer service representative will contact the medical facility with a Return Goods Authorization number and provide instructions for return of the product to Teleflex.  The Acknowledgment Form should also be returned if no product is in inventory.\n\nFor distributors, they are to provide the recall letter to all customers who have received the product.  Each customer is required to complete and return the Acknowledgement Form.  The distributor is also supposed to check their inventory, cease distribution and quarantine the affected product.  The Acknowledgment Form is to be completed and returned for product in their inventory as well as if they have no inventory.  If the distributor has distributed product outside of the country, they are to notify Teleflex Customer Service.\n\nAdditionally, the recall letter says that this notice should be passed onto all persons who need to be aware within their organization or to any organizations where the potentially affected devices have been transferred.  This would include users, clinicians, risk managers, supply chain/distribution centers, etc. in the circulation of the notice.",
      "product_quantity": "59,581 eaches",
      "distribution_pattern": "Worldwide distribution - US Nationwide distribution in the states of AL, AR, AZ, CA, CO, FL, GA, HI, IA, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, NC, NJ, NV, NY, OH, PA, SC, TN, TX, UT, VA, WA, WI, and WV. The countries of Austria, Australia, Belgium, Canada, Chile, Czech Republic, Finland, France, Germany, Greece, Hong Kong, Hungary, Korea, Malaysia, Netherlands, Panama, Poland, Slovakia, Spain, and Switzerland.",
      "openfda": {
        "k_number": [
          "K840399",
          "K904193",
          "K941535",
          "K954194",
          "K941813",
          "K950447",
          "K923865",
          "K952844",
          "K942794",
          "K951856",
          "K903058",
          "K953507",
          "K944194",
          "K912334",
          "K952084",
          "K840398",
          "K873768",
          "K864095",
          "K953620",
          "K941436",
          "K952823",
          "K945657",
          "K914336",
          "K885313",
          "K953544",
          "K872153",
          "K953540",
          "K902501",
          "K946209",
          "K934441",
          "K941987",
          "K945359",
          "K952750",
          "K952845",
          "K925622",
          "K821365",
          "K915786",
          "K912333",
          "K955008",
          "K834292",
          "K854012",
          "K934190",
          "K881656",
          "K881308",
          "K903519",
          "K935036",
          "K790681",
          "K952036",
          "K912700",
          "K881644",
          "K873767",
          "K923910",
          "K872371",
          "K953580",
          "K953619",
          "K953491",
          "K844040",
          "K912335",
          "K900150",
          "K912699",
          "K912336",
          "K893875",
          "K922946",
          "K852601",
          "K904338",
          "K943915",
          "K881657",
          "K874597",
          "K903057",
          "K862020",
          "K941585",
          "K933597",
          "K903054"
        ],
        "registration_number": [
          "",
          "9611500",
          "3016734145",
          "1824226",
          "3015142701",
          "3011587055",
          "3014579161",
          "3004428458",
          "3006984712",
          "3004905643",
          "9617616",
          "9710567",
          "8010485",
          "3015495690",
          "3030733800",
          "3008311916",
          "3022568093",
          "3021039857",
          "8043316",
          "2028807",
          "3013530359",
          "3003898360",
          "2936999",
          "3031233007",
          "3004030908",
          "3002806603",
          "2183585",
          "3012262567",
          "3010877292",
          "3005012805",
          "9680661",
          "3005587132",
          "3018094310",
          "3006563173",
          "3003836856",
          "3004530184",
          "3020777588",
          "3006783791",
          "3014747754",
          "2024841",
          "3001313714",
          "3010131137",
          "3011137372",
          "3014208300",
          "3045058049",
          "3009171251",
          "3013242701",
          "8030673",
          "3009887154",
          "3012002722",
          "8021995",
          "3013507143",
          "3031369651",
          "3010515776",
          "2031897",
          "1417592",
          "1423662",
          "1928237",
          "3005515211",
          "3005998497",
          "9616445",
          "3005519819",
          "3003862188",
          "8032044",
          "3037918935",
          "3008278458",
          "1314417",
          "3004116032",
          "3016674860",
          "3010321647",
          "3002807267",
          "2025816",
          "8010042",
          "3021244152",
          "3016634999",
          "2025182",
          "9710644",
          "3043226252",
          "9617604",
          "3006534321",
          "3005855942",
          "3017937889",
          "3012521761",
          "3010187802",
          "3013188547",
          "3010838917",
          "3010889742",
          "3008693658",
          "3003902312",
          "3043619925",
          "3011270181",
          "3002907620",
          "1832562",
          "3006061749",
          "3013576541",
          "3014054118",
          "3004050971",
          "3012453745",
          "3011503227",
          "3007648359",
          "3010834934",
          "1000604079",
          "3004365956",
          "3008770104",
          "3010220595",
          "8040412",
          "3023464160",
          "3004548776",
          "3009747810",
          "3010402691",
          "3006446479",
          "3004824601",
          "3030447506",
          "3012494290",
          "2529776",
          "3016458361",
          "3044994756",
          "3011987967",
          "3016904853",
          "1220479",
          "3008567544",
          "3010957755",
          "3008806809",
          "3013557562",
          "1058584",
          "9616567"
        ],
        "fei_number": [
          "",
          "3016734145",
          "1824226",
          "3015142701",
          "3002808696",
          "3011587055",
          "3014579161",
          "3002807293",
          "3005749238",
          "3004428458",
          "3006984712",
          "3004905643",
          "3005747797",
          "3015495690",
          "3030733800",
          "3008311916",
          "3022568093",
          "3021039857",
          "3013530359",
          "3003898360",
          "3000215273",
          "2936999",
          "3031233007",
          "3004030908",
          "3003272754",
          "3002806603",
          "2183585",
          "3008581151",
          "3012262567",
          "3010877292",
          "3001104093",
          "3005012805",
          "3005587132",
          "3018094310",
          "3006563173",
          "3003319165",
          "3003836856",
          "3004530184",
          "3020777588",
          "3006783791",
          "3014747754",
          "2024841",
          "3010131137",
          "1000219637",
          "3003949221",
          "3014208300",
          "3006759904",
          "3002963732",
          "3045058049",
          "3013242701",
          "3009887154",
          "3012002722",
          "3013507143",
          "3031369651",
          "3010515776",
          "1417592",
          "1928237",
          "3002806269",
          "3005515211",
          "3005998497",
          "3005519819",
          "3003862188",
          "3037918935",
          "3008278458",
          "1314417",
          "3004116032",
          "3016674860",
          "3004213967",
          "3010321647",
          "3002807267",
          "2025816",
          "3021244152",
          "3016634999",
          "2025182",
          "3002808128",
          "3043226252",
          "3006534321",
          "3005855942",
          "3017937889",
          "3003361161",
          "3012521761",
          "3013188547",
          "3010187802",
          "3010838917",
          "1000374126",
          "3010889742",
          "3002558692",
          "3008693658",
          "3003902312",
          "3043619925",
          "3011270181",
          "3002907620",
          "1832562",
          "3006061749",
          "3013576541",
          "3014054118",
          "3004050971",
          "3012453745",
          "3009271244",
          "3011503227",
          "3007648359",
          "3010834934",
          "1000604079",
          "3004365956",
          "3006363476",
          "3008770104",
          "3010220595",
          "3023464160",
          "3004548776",
          "3009747810",
          "3010402691",
          "3006446479",
          "1000121196",
          "3004824601",
          "3030447506",
          "3012494290",
          "3016458361",
          "3044994756",
          "3011987967",
          "3016904853",
          "1220479",
          "3008567544",
          "3010957755",
          "3008806809",
          "3013557562",
          "3003256355"
        ],
        "device_name": "Condenser, Heat And Moisture (Artificial Nose)",
        "medical_specialty_description": "Anesthesiology",
        "regulation_number": "868.5375",
        "device_class": "1"
      }
    }
  ]
}