{
  "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": "2026-08-20",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "cfres_id": "35105",
      "product_res_number": "Z-0260-05",
      "event_date_initiated": "2004-10-25",
      "event_date_posted": "2004-11-30",
      "recall_status": "Terminated",
      "event_date_terminated": "2006-02-08",
      "res_event_number": "30065",
      "product_code": "IKZ",
      "product_description": "XPRT Therapy Mattress Systems:\nModel # 2950-000-000 with Dartex urethane-coated nylon cover (deluxe cover); and Model # 2950-000-001 with nylon cover without coating (standard cover).  \nResponsible firm on the label:  Manufactured for STRYKER MEDICAL, 6300 South Sprinkle Road, Kalamazoo, MI USA 49001-9799, 1-800-327-0770.\n\nThe unit consists of a sleep surface, an integrated valve box located in the head of the mattress, a pump box located under the foot of the mattress and a color touch screen controller that can be mounted to either side of the pump box at the foot end of the mattress.",
      "code_info": "The following serial numbers, which represent all units shipped:  H40001 thru H40038; and I40001, I40003, I40004,  I40005, I40006, I40009,  I40012, I40013, I40014, I40017, I40018,  and I40021.",
      "firm_fei_number": "1313850",
      "recalling_firm": "Gaymar Industries Inc",
      "address_1": "10 Centre Dr",
      "city": "Orchard Park",
      "state": "NY",
      "postal_code": "14127-2280",
      "additional_info_contact": "Chuck Dunlap\n800-828-7341 Ext. 644",
      "reason_for_recall": "Design control/validation deficiencies.",
      "root_cause_description": "Other",
      "action": "Letter dated 10/25/2004 to Stryker Medical, own-label distributor, with instructions to remove patients from the system and return units to Gaymar.",
      "product_quantity": "48 units",
      "distribution_pattern": "The units were sold to the own-label distributor, who in turn sold 8 units to two hospitals in Nebraska and Hawaii.",
      "openfda": {
        "k_number": [
          "K922473",
          "K950681",
          "K972486",
          "K954671",
          "K822402",
          "K842604",
          "K933964",
          "K972111",
          "K905113",
          "K873047",
          "K962788",
          "K905390",
          "K923710",
          "K810220",
          "K823095",
          "K950756",
          "K834563"
        ],
        "device_name": "Bed, Patient Rotation, Powered",
        "medical_specialty_description": "Physical Medicine",
        "regulation_number": "890.5225",
        "device_class": "2",
        "registration_number": [
          "3015423385",
          "3016947689",
          "3013846070",
          "2030732",
          "3018115441",
          "2032121",
          "3002798200",
          "3009591865",
          "3006891315",
          "8044130",
          "3007420694",
          "3005179379",
          "3038008630",
          "1043644",
          "1831750",
          "3040337865",
          "3030492371",
          "1954156",
          "9681684",
          "1931307"
        ],
        "fei_number": [
          "3015423385",
          "3016947689",
          "3013846070",
          "3018115441",
          "3002693132",
          "3002798200",
          "3000204953",
          "3009591865",
          "3006891315",
          "3007420694",
          "3005179379",
          "3038008630",
          "1043644",
          "1831750",
          "3040337865",
          "3030492371",
          "3005743621",
          "3002655016",
          "3003083675",
          "1931307"
        ]
      }
    }
  ]
}