{
  "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": "2026-04-22",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "status": "Ongoing",
      "city": "Kansas City",
      "state": "MO",
      "country": "United States",
      "classification": "Class II",
      "openfda": {},
      "product_type": "Devices",
      "event_id": "78877",
      "recalling_firm": "Southwest Technologies Inc",
      "address_1": "1746 E Levee St",
      "address_2": "N/A",
      "postal_code": "64116-4404",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "worldwide",
      "recall_number": "Z-1600-2018",
      "product_description": "HYPOTHERMIA CAP Supportive in Cancer, packaged under the following brands:  (a) Elasto-Gel(TM), CAP610  (b) Elasto-Gel(TM), CAP610LV  (c) Elasto-Gel(TM), CAP613  (d) Elasto-Gel(TM), CAP617  (e) Elasto-Gel(TM), CAP619  (f) Elasto-Gel(TM), CAP619LV  (g) Elasto-Gel(TM), CAP622",
      "product_quantity": "15666 units",
      "reason_for_recall": "Hypothermia mitts, hypothermia slippers, and hypothermia caps on the market are misbranded for use during chemotherapy treatments.  Additionally, Southwest Technologies, Inc. was informed of 2 events of frostbite to digits in the last year while using the hypothermia mitts.",
      "recall_initiation_date": "20171228",
      "center_classification_date": "20180503",
      "report_date": "20180509",
      "code_info": "US distribution:  (a) CAP610, Lot Numbers:    020613D  112912B  101312C  040813B  070213F  081513B  100113C  111413B  020314C  032516B  040514B  061014D  072214C  072214C  090914D  090914D  111814B  012115C  032715B  040915D  041615C  043015D  070915D  081815B  090115B  101215C  111315B  122115C  010616B  012116B  022316C  030116B  030515D  031016B  042516C  050616B  052016C  053116C  070816C  072516C  081216B  090216B  091416F  101316D       (b) CAP610LV, Lot Numbers:    121912D  041013E  070813B  102413B  121913C  031414D  082014C  091615D      OUS distribution:  (a) CAP610, Lot Numbers:  011210B  012116B  020110B  020314C  022017B  022316C  030116B  030210B  030711D  032715B  040317C  040514B  040813B  042516C  043015D  050112C  052016C  053116C  060311B  070816C  070915D  072214C  072516C  072817d  081710B  082409B  090115B  091311B  101215C  101312C  101316D  111011B  111413B  111710C  111716L  111814B  112912B  172817d    (b) CAP610LV, Lot Numbers:  050610D  091710B  120110B  030711C  040211D  062711C  091311C  031912E  051712C  091112C  102912B  121912D  041013E  070813B  102413B  121913C  031414D  070914C  082014C  110714C  121114C  010815D  041615D  051315C  061615B  091615D  112315B  012116C  021516B  040716B  041516B  052416B  072816B  091616C  101816B  013117C  022117D  030217C  032817D  050317B  071117D    (c) CAP613, Lot Numbers:  093015B    (d) CAP617, Lot Numbers:  080510D  120211D  092012D  101013B  042215C  102616B    (e) CAP619, Lot Numbers:  062309B  051210C  091010C  101910C  112811E    (f) CAP619LV, Lot Numbers:  061212C  030513H  100113D  101713C  052114B  110714D  121114D  061515C  091715D  112315C  012116D  021516C  040716C  041516C  013117D  050317C  061217C    (g) CAP622, Lot Numbers: 110210C"
    }
  ]
}