{
  "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": "2026-03-18",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "status": "Ongoing",
      "city": "Tempe",
      "state": "AZ",
      "country": "United States",
      "classification": "Class II",
      "openfda": {},
      "product_type": "Devices",
      "event_id": "91845",
      "recalling_firm": "Stryker Sustainability Solutions",
      "address_1": "1810 W Drake Dr",
      "address_2": "N/A",
      "postal_code": "85283-4327",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "US: WI, MD, NY, PA, WA, CO, GA, FL, OH, NC, TX, NJ, OR, MT, CA, RI, SC, NE, MI, LA, OK, SD, AL, VA, MS, WV, AZ, KY, IL, AR, ME, ND, MO, KS, HI, NH, AK, TN, IA, MN, IN, NV, MA, ID, DE, NM, WY, DC, VT, CT",
      "recall_number": "Z-1315-2023",
      "product_description": "Color Cuff Single Port, Single Bladder 30  (Royal Blue) Quick Connect, REF: 5921-030-135;\t\t\t\t\t\t\t\t Color Cuff Dual Port, Single Bladder 30  (Royal Blue) Quick Connect, REF: 5921-030-235;\t\t\t\t\t\t\t\t Color Cuff Single Port, Single Bladder 34  (Purple), Quick Connect, REF:\t5921-034-135;\t\t\t\t\t\t Color Cuff Dual Port, Single Bladder 34  (Purple), Quick Connect,\tREF: 5921-034-235;\t\t\t\t\t\t\t Color Cuff Single Port, Single Bladder 18  (Red), Quick Connect, REF: 5921-218-135;\t\t\t\t\t\t\t\t Color Cuff Dual Port, Single Bladder 18  (Red), Quick Connect, REF: 5921-218-235;",
      "product_quantity": "127,894",
      "reason_for_recall": "Increased incidence of disposable tourniquet cuffs \"not able to achieve desired pressure\" and \"not holding pressure\" due to 1) Cuff fabric tearing during use, and 2) Pinched or unseated O-ring at the connection between the cuff, disposable fill line, and/or cuff hosing, which may lead to loss of vascular occlusion, which may lead to operative site blood loss, hemorrhage, or other complications.",
      "recall_initiation_date": "20230301",
      "center_classification_date": "20230330",
      "report_date": "20230405",
      "code_info": "REF/UI-DI:  5921-030-135/885825016142,     5921-030-235/885825016166,     5921-034-135/885825016173,     5921-034-235/885825016197,     5921-218-135/885825016500,     5921-218-235/885825016296     Lots: 0000202775, 0000209215, 0000202137, 0000201380, 0000200708, 13872322, 13453772, 0000198235, 0000202066, 0000209420, 0000206425, 0000192978, 0000202577, 0000192465, 13463347, 0000204578, 0000193181, 0000198446, 0000208949, 0000195337, 0000206263, 0000193179, 13486613, 0000202777, 0000195071, 0000204159, 0000195912, 0000200905, 0000206442, 0000197869, 13594486, 0000192979, 0000200706, 0000195068, 0000201379, 0000199502, 0000199434, 0000188863, 13493683, 0000193177, 0000202065, 0000200712, 0000200242, 0000202138, 13582864, 0000195075, 13570832, 0000199808, 0000202075, 0000195340, 0000200254, 0000202932, 13774680, 13851472, 13634704, 0000199819, 0000204319, 0000204160, 0000201378, 0000200227, 0000203311, 0000206583, 13235119, 0000194243, 0000196364, 0000193841, 0000200270, 13828088, 0000196363, 13392486, 13280380, 0000192981, 0000198461, 0000196361, 0000200244, 0000203310, 0000200229, 13398036, 13352572, 0000194232, 0000200253, 0000198245, 0000202776, 0000197373, 0000187746, 13765829, 13449838, 0000200256, 0000202145, 0000198246, 0000198236, 0000204574, 0000202143, 0000194242, 13583025, 0000202074, 0000203315, 0000195073, 0000193176, 0000212764, 0000196379, 13811283, 13605685, 0000187310, 0000208444, 0000204366, 0000197867, 13865381, 13820702, 0000176566, 13663274, 0000196365, 0000210787, 0000206440, 0000193391, 0000201391, 0000193412, 0000177131, 13883084, 0000198460, 0000208345, 0000206443, 0000192466, 0000210962, 0000200230, 0000204570, 13339407, 0000204314, 0000211530, 0000209200, 0000196359, 0000210005, 0000201840, 0000205922, 0000192980, 0000205238, 0000195335, 0000206518, 0000195067, 0000203313, 0000193393, 0000206254, 0000208440, 0000202686, 0000198244, 0000203314, 0000195069, 0000208407, 0000206432, 13632837, 0000210465, 0000206505, 0000172873, 0000195338, 0000199805, 0000208321, 0000195343, 0000205241, 0000200707, 0000199807, 0000195076, 0000197375, 0000203312, 13870728, 0000202139, 0000206511, 0000193392, 13824462, 0000195070, 0000199816, 0000208410, 13871893, 0000199503, 0000206586, 13272167, 13399919, 0000195072, 0000199817, 0000192977, 0000197872, 0000186596, 0000208322, 13573489, 0000209992, 0000202684, 0000211154, 0000201837, 0000210310, 0000197870, 0000208606, 0000204571, 13883045, 0000197376, 0000194228, 0000204195, 0000198237, 0000212878, 0000209416, 0000210963, 0000210601, 0000200711, 0000194229, 0000204372, 0000196362, 13807840, 0000210008, 0000200228, 0000172314, 0000200257, 0000194230, 0000205930, 0000193839, 0000193178, 0000210313, 0000198459, 13814050, 0000202144, 0000193413, 0000195336, 13765599, 0000208951, 0000195078, 0000194227, 0000193838, 0000193840, 0000202778"
    }
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}