{
  "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": "2026-08-13",
    "results": {
      "skip": 0,
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  "results": [
    {
      "cfres_id": "196048",
      "product_res_number": "Z-0179-2023",
      "event_date_initiated": "2022-09-20",
      "event_date_posted": "2022-11-03",
      "recall_status": "Open, Classified",
      "res_event_number": "90848",
      "product_code": "GDC",
      "product_description": "Allen Life Assist Beach Chair, BCSSP-BEACH CHAIR , REF A-91501, #104002.  For use with orthopaedic procedures using the Fowlers or beach chair position.",
      "code_info": "UDI/DI 00615521004125, Lot Number:  22-123",
      "firm_fei_number": "1417572",
      "recalling_firm": "Baxter Healthcare Corporation",
      "address_1": "1 Baxter Pkwy",
      "city": "Deerfield",
      "state": "IL",
      "postal_code": "60015-4625",
      "additional_info_contact": "Center for One Baxter\n800-422-9837",
      "reason_for_recall": "the adhesive, applied to screws and bolts as an additional holding force, may not cure correctly, and as a result, could result in a loss of holding and reduced mechanical integrity.",
      "root_cause_description": "Other",
      "action": "The firm issued an Urgent Medical Device Correction notice to their consignee on 09/20/2022 by email.  The notice explained the problem, risk, and requested the following:  \"Actions to be taken by Customer:\n1. Identify the impacted lot number listed on page 1 and stop any use of the product immediately.\n2. Hillrom will contact you to perform a correction of your impacted device as soon as possible.\"\n\nThe firm issued an Urgent Medical Device Recall notice to their consignees on 09/27/2022 by FedEx 2nd day delivery.  The notice explained the problem, risk, and requested the following: \"Actions to be taken by Customer:\n1. Identify the impacted lot numbers listed in the above table and replace with the enclosed device that accompanies this notification.\n2. Please return the impacted unit per RMA instructions attached within 10 business days.\nActions to be taken by Distributor:\n1. Please forward this notification to your end users along with replacement parts accompanying this notification.\n2. Please request return of the impacted devices from your end users and return the devices to Hillrom, per RMA instructions attached.\"\n\nBoth notices provided the following contact information:  \"Contact reference person\nIf you have any questions regarding this Urgent Medical Device Correction, please contact Hillrom Technical Support at 800-445-3720 or technical.support@hillrom.com\"",
      "product_quantity": "1 unit",
      "distribution_pattern": "MI, BA, WI, WA, TX, and Germany, Japan, South Korea, Sweden, South Africa",
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        "device_name": "Table, Operating-Room, Electrical",
        "medical_specialty_description": "General, Plastic Surgery",
        "regulation_number": "878.4960",
        "device_class": "1",
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