{
  "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": "2026-04-01",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "status": "Ongoing",
      "city": "LEJRE",
      "state": "N/A",
      "country": "Denmark",
      "classification": "Class II",
      "openfda": {},
      "product_type": "Devices",
      "event_id": "90719",
      "recalling_firm": "Unomedical A/S",
      "address_1": "Aaholmvej 1 - 3",
      "address_2": "OSTED",
      "postal_code": "N/A",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "Distribution was made to California.  There was no government/military distribution.",
      "recall_number": "Z-1810-2022",
      "product_description": "Autosoft 90, model numbers 1000282, 1002817, 1002818, 1002819, 1002820, 1002821, 1002822, 1002823, and 1002824.  Infusion sets used with Tandem Insulin Subcutaneous Infusion Pump.",
      "product_quantity": "1,643,320 units",
      "reason_for_recall": "The IFU incorrectly states the insulin fill value of two sizes of cannula which can result in an initial insulin infusion to be fewer units than intended.",
      "recall_initiation_date": "20220721",
      "center_classification_date": "20220926",
      "report_date": "20221005",
      "code_info": "UDI-DI: 05705244018129.  Model 1000282, lot numbers: 5381154 and 5381155;  Model 1002817, lot numbers: 5372743, 5381082, 5381087, 5381083, 5381088, 5381091, 5381159, 5381084, 5381089, 5381160, 5381092, 5381094, 5381156, 5381157, 5381090, 5381158, 5372745, 5381085, 5381093, 5381086, 5381101,5372744, 5381095, 5381096, 5381097, 5381099, 5381098, 5381100, 5381162, 5381107, 5381103, 5381102, 5381104, 5381108, 5381164, 5381105, 5381109, 5381161, 5381163, 5381166, 5381106, 5381165, 5381169, 5381168, 5381172, 5381167, 5381170, 5381171, 5381173, 5381178, 5381175, 5381179, 5381180, 5381176, 5381174, 5381177, 5381181, 5381182, 5381183, 5381184, 5381186, 5381189, 5381197, 5381190, 5381192, and 5381194;  Model 1002818, lot numbers: 5381110, 5381111, 5381112, 5381113, and 5381200;  Model 1002819, lot numbers: 5372758, 5381114, 5372759, 5381115, 5372756, 5381117, 5381118, 5381121, 5381116, 5381120, 5381122, 5381205, 5381208, 5381202, 5381119, 5381204, 5381203, 5381207, 5381206, and 5381209.  Model 1002820, lot numbers: 5372762, 5381123, 5381124, 5383835, 5381125, and 5381215;  Model 1002821, lot numbers: 5381126, 5381127, 5381128, 5381129, 5381130, 5381133, 5381134, 5381132, 5381131, 5381218, 5381223, 5381219, 5381221, 5381220, 5381222, and 5381224;  Model 1002822, lot numbers: 5381135, 5381136, and 5381228.  Model 1002823, lot numbers: 5381139, 5381137, 5381138, 5381140, 5381141, 5381142, 5381144, 5381145, 5381146, 5381147, 5381143, 5381148, 5381149, 5381230, 5381229, 5381232, 5381231, 5381233, 5381234, 5381235, and 5381238; and   Model, 1002824, lot numbers: 5376469 and 5381243."
    }
  ]
}