{
  "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": "2026-09-10",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "cfres_id": "192277",
      "product_res_number": "Z-0918-2022",
      "event_date_initiated": "2022-03-14",
      "event_date_created": "2022-04-14",
      "recall_status": "Open, Classified",
      "res_event_number": "89707",
      "product_code": "OYS",
      "product_description": "Cub 2 Enclosed Bed Canopy System",
      "code_info": "Model/Product Code - Cub2\nUDI Code: None\nSerial Numbers: All device manufactured/distributed prior to 12/16/2021.",
      "firm_fei_number": "3016541541",
      "recalling_firm": "Sensory Medical Inc",
      "address_1": "3333 S Wadsworth Blvd Unit D321 3333 S Wadsworth Blvd",
      "address_2": "Unit D321",
      "city": "Lakewood",
      "state": "CO",
      "postal_code": "80227-5142",
      "additional_info_contact": "Caleb Polley\n855-964-2664",
      "reason_for_recall": "Due potential misuse of the product, firm is updating warnings and precautions booklet for products distributed before December 16, 2021.",
      "root_cause_description": "Labeling Change Control",
      "action": "On 03/14/2022, the firm, CUBBY, initiated calling its customers to inform them of an \"URGENT-VOLUNTARY MEDICAL DEVICE CORRECTION\" associated with Cubby Beds distributed between 02/24/2020 thru 12/16/2021 and the potential for the risk of misuse and possible entrapment.  \n\nBetween 03/15-16/2022, the firm mailed an URGENT VOLUNTARY MEDICAL DEVICE CORRECTION\" Letter along with the updated Warnings & Precautions Booklet and new Product/User manuals. \n\nThe Customer Notification Letter instructed customers to:\n1.\tIdentify/Locate Affected Product.  Check their records and make sure that it is in fact a unit impacted by this voluntary medical device correction.\n2.\tAdd/Secure the Warning & Precautions Booklet to the Cubby Bed.\n3.\tLocate, Remove, Destroy, and Update/Replace the Old Cubby Bed Product/User Manuals. First, locate the old/outdated product/user manuals from wherever it has been placed/stored.  Destroy and discard this outdated product/user manuals in such a fashion so that it cannot be used in the future.  Next, locate the updated product/user manuals that were provided with this Voluntary Medical Device Correction.  Place and/or store these product/user manuals in an area close to/near the bed so they are readily available for use as needed.  Ensure that anyone who provides patient care understands the content of these product/user manuals and knows where to find/locate them when needed.\n5.\tEnsure Completion of All Steps & Completion of the Hardcopy or Online Verification Form.  Double check and verify that all the steps outlined within the Steps for Voluntary Medical Device Correction have been properly completed/addressed. \n\nShould you have any questions or concerns about this correspondence, please contact, John Sawyer, Vice-President, Quality Assurance and Regulatory Affairs at (855) 964-2664 or email at Hello@cubbybeds.com.",
      "product_quantity": "225 devices",
      "distribution_pattern": "U.S. Nationwide distribution to states including: AK, AZ, CA, CO, CT, DE, FL, GA, HI, ID, IL, IN, KS, KY, LA, MA. MD, MI, MN, MO. MS. NC, ND, NH, NJ, NM, NV, NY, OH, OK, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, and WI; and O.U.S Internationally to: Canada",
      "openfda": {
        "registration_number": [
          "3006795806",
          "3014268229",
          "3031564213",
          "3008830652",
          "3016541541",
          "3018490352",
          "3008061384",
          "3010699203",
          "2182318",
          "3008431074",
          "3011389091"
        ],
        "fei_number": [
          "3006795806",
          "3014268229",
          "3031564213",
          "3008830652",
          "3016541541",
          "3018490352",
          "3008061384",
          "3010699203",
          "2182318",
          "3008431074",
          "3011389091"
        ],
        "device_name": "Patient Bed With Canopy/Restraints",
        "medical_specialty_description": "General Hospital",
        "regulation_number": "880.6760",
        "device_class": "1",
        "k_number": [
          "K113357",
          "K103817",
          "K113355"
        ]
      }
    }
  ]
}