{
  "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": "2026-09-17",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 10
    }
  },
  "results": [
    {
      "cfres_id": "218605",
      "product_res_number": "Z-1499-2026",
      "event_date_initiated": "2025-08-13",
      "event_date_posted": "2026-03-09",
      "recall_status": "Open, Classified",
      "res_event_number": "98396",
      "product_code": "ILJ",
      "k_numbers": [
        "K040772"
      ],
      "product_description": "Penner Pacific Bathing Spa, Model Numbers 350010-1, 350000-2, 350010-X",
      "code_info": "UDI-DI: 0085007365400;\nSerial Numbers: 06020315401\n08010223607\n04205543401\n05246707501\n05246707502\n02195222101\n11216213301\n09185118801\n10216206001\n10216206002\n11216222201\n11216222202\n05246717201\n02195236901\n11195422801\n01246647601\n01246656501\n04205544901\n12205685701\n09236590301\n11195432401",
      "firm_fei_number": "1922538",
      "recalling_firm": "Penner Patient Care, Inc.",
      "address_1": "101 Grant St",
      "city": "Aurora",
      "state": "NE",
      "postal_code": "68818-3200",
      "additional_info_contact": "Kevin Walls\n720-254-5756",
      "reason_for_recall": "The device does not bear a unique device identifier.",
      "root_cause_description": "Error in labeling",
      "action": "Recall notification letters were sent to customers beginning 8/13/25.\n\nYour facility has been identified as one that has purchased a Penner Bathing Spa and must place the label(s) attached to this letter(s) next to the current serial tag on your existing Penner Spa and, if applicable, Penner Reservoir. The existing serial tags are located on the side of the spa or reservoir. The serial tag is located behind the TV if you have a Penner Premier Spa with a TV in the cabinet.\n\nThe last 11 numbers on the UDI label should match the serial number of your existing Penner Spa or Penner Reservoir. Please make sure you attach the corresponding UDI label to the correct Penner product.\n\nIf you have any questions, please don t hesitate to call our office at 1-800-732-0717.",
      "product_quantity": "21 units",
      "distribution_pattern": "US Nationwide distribution.",
      "openfda": {
        "k_number": [
          "K040772",
          "K771965",
          "K771969",
          "K842941",
          "K810034",
          "K925193",
          "K930624",
          "K890548",
          "K905599",
          "K812033",
          "K052479",
          "K980909",
          "K811903",
          "K872327",
          "K971593",
          "K980033",
          "K993872",
          "K771971",
          "K991184",
          "K861218",
          "K904106",
          "K883308",
          "K821809",
          "K890308",
          "K864721",
          "K910607",
          "K841954",
          "K833839",
          "K844064",
          "K082951",
          "K980920",
          "K971592",
          "K854861",
          "K012061",
          "K923617",
          "K880355",
          "K925195",
          "K952442",
          "K922160",
          "K802335",
          "K012057",
          "K842643",
          "K930820",
          "K001079",
          "K840282",
          "K771967",
          "K791603",
          "K771966",
          "K930096",
          "K911551",
          "K792641",
          "K853163",
          "K771968",
          "K930665",
          "K791718",
          "K841397",
          "K771970",
          "K964926",
          "K911758",
          "K974321",
          "K854263",
          "K811904",
          "K914125",
          "K923637",
          "K883187",
          "K902603",
          "K842642",
          "K930821",
          "K923159",
          "K110994",
          "K992779",
          "K842641",
          "K980769"
        ],
        "device_name": "Bath, Hydro-Massage",
        "medical_specialty_description": "Physical Medicine",
        "regulation_number": "890.5100",
        "device_class": "2",
        "registration_number": [
          "3042227943",
          "3007420694",
          "3016446653",
          "3026182452",
          "3009529084",
          "1922538",
          "3010010434",
          "3015139841"
        ],
        "fei_number": [
          "3042227943",
          "3007420694",
          "3016446653",
          "3026182452",
          "3009529084",
          "1922538",
          "3010010434",
          "3015139841"
        ]
      }
    }
  ]
}