{
  "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-1601-2018",
      "product_description": "HYPOTHERMIA MITTS Supportive in Cancer, packaged under the following brands:  (a) Elasto-Gel(TM), TM7006  (b) Elasto-Gel(TM), TM7006LV  (c) Elasto-Gel(TM), TM7007  (d) Elasto-Gel(TM), TM7008  (e) Elasto-Gel(TM), TM7008b  (f) Elasto-Gel(TM), TM7009  (g) Elasto-Gel(TM), TM7010  (h) Elasto-Gel(TM), TM7011  (i) Elasto-Gel(TM), TM7012",
      "product_quantity": "15434 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) TM7006, Lot numbers:  060805B, 050415D   (b) TM7008, Lot numbers:  031111B, 100511D, 012512C, 031912B, 071212D, 122612C, 021813C, 030513B, 031309D, 052213D, 090313E, 120613C, 022714D, 040114B    OUS distribution:  (a) TM7006, Lot Numbers:   090909C  102209C  031710D  050510D  080910B  010611B  031111C  090811D  100511C  060612D  101212B  110712D  020613C  070213E  101713B  031414C  063014D  092914C  101614B  012115D  050415D  111015D  020316B  042116D  101116D    (b) TM7006LV, Lot Numbers:  022117B  032817B  050317D  061917D  071217C    (c) TM7007, Lot Numbers:  032410D, 110210D    (d) TM7008, Lot Numbers:  120709B  040210D  050610B  031111B  082311B  080911D  100511D  012512C  031912B  071212D  122612C  021813C  030513B  052213D  090313E  120613C  022714D  040114B  051414C  102714D  090814C  121614D  041015C  051815D  091115B  101715C  121015D  030316B  032116C  042016C  060116C  082316F  101116C  022017C  041817C    (e) TM7009, Lot Numbers:  080510C  120211E  092012C  101013C  042215B  102616C    (f) TM7010, Lot Numbers:  030110D    (g) TM7011, Lot Numbers:  030110E    (h) TM7012, Lot Numbers: 042110D"
    }
  ]
}