{ "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": "2026-09-03", "results": { "skip": 0, "limit": 1, "total": 1 } }, "results": [ { "cfres_id": "221336", "product_res_number": "Z-2725-2026", "event_date_initiated": "2026-06-30", "event_date_posted": "2026-07-10", "recall_status": "Open, Classified", "res_event_number": "99336", "product_code": "KYZ", "product_description": "Rapid Refill Continuous Injection System, UPN M00566001", "code_info": "UDI-DI (GTIN) 08714729285151\n\nLots \n33786611, 33825949, 33826026, 33949916, 33968571,\n33968575, 34079981, 34153104, 34153413, 34153415,\n34203075, 34203077, 34153411, 34203079, 34203115,\n34386605, 34386609, 34386613, 34429656, 34429658,\n34595249, 34693559, 34616613, 34616615, 34712433,\n34763427, 34763967, 34805723, 34805725, 34805729,\n35006995, 35006999, 35056793, 35208946, 35186845,\n35208950, 35397314, 35208952, 35305436, 35498030,\n35448316, 35498028, 35551523, 35626939, 35574463,\n35688118, 35688460, 35828714,35831703, 35848483,\n35877768, 35995282, 36049415, 36159194, 36219882,\n36294100, 36303614, 36332230, 31177006, 31180206,\n31666278, 31329922, 31356107, 31666276, 31798400,\n31798133, 31798135, 31798137, 31852246, 32162450,\n32208753, 32255526, 32255528, 32496142, 32661870,\n32696046, 32696050, 32696052, 32752697, 32773682,\n32791475, 32791477, 32820865, 32838612, 32791479,\n33119798, 32977346, 32977348, 33030942, 33120320,\n33158008, 33158006, 33354311, 33354315, 33354317,\n33403248, 33403252, 33696882, 33696884, 33696886,\n33696888, 33750883, 33750885, 33750887, 36332232,\n36497262, 36159192, 36587704, 36612263, 36739668,\n36785215, 36785217, 36814560, 36845486, 36983883,\n36983886, 37291592, 37059471, 37417957, 37417959,\n37429808, 37456936, 37472523, 37585745, 37627037,\n37654892, 37941477, 37974508, 38033021, 38033023,\n38124799, 38143635, 38165214, 38182214, 38201123,\n37959187, 38353956, 38374833, 38430201, 33968573,\n34386611, 32838610, 38205377, 38429054, 34066207,\n34429654, 34616611, 34712429, 34763971, 34805727,\n35006997, 35448312, 35448314, 35626937, 35688021,\n35848481, 35687399, 31616842, 31601573, 31616848,\n31616850, 31616846, 32208755, 32455154, 35877766,\n36776858, 37037796, 37200706, 37276220, 37291594,\n37639238, 38154387, 35305438, 31797614, 33354313,\n33696890, 36470789, 37309672, 37396601, 37407323,\n37472521, 35056797, 35626933, 33786613, 33825951,\n33950422, 34965218, 35056795, 36101020, 36100418,\n31356105, 32208759, 32661868, 33030940, 33679650,\n37059473, 37041524, 37633157, 37991645, 38137850,\n38393609, 33968569, 34703963, 36319481, 33649863,\n37019542, 37493275, 34616609, 34386607, 34763969,\n34805721, 35942747, 31852244, 32977350, 33354319,\n37884043, 38001944, 32752695, 37189280, 37612931,\n38703180, 34429700, 33968567, 34017321, 34568306,\n34712431, 34873735, 34873737, 34965420, 35007081,\n35186843, 35208948, 35397312, 35448310, 35305600,\n35626935, 35778515, 35778517, 35778513, 35989120,\n36027670, 36049413, 36303612, 36319483, 36312073,\n36353951, 36437019, 36517931, 36409546, 36537384,\n36622267, 36750117, 36750119, 36994750, 36962014,\n37407325, 37456934, 37766480, 37660978, 37764898,\n37723376, 37991643, 38856580, 38178214, 38337853,\n38326961, 38410111, 38414293, 38576233, 38586789,\n38622115, 38633220, 38676778, 38649491, 38680582,\n38864691, 38687308, 38876174, 38901702, 31170922,\n31601571, 31616844, 31852242, 31852240, 32162448,\n32208757, 32696048, 32723872, 32723874, 32838608,\n32964550, 32977344, 33119794, 33119796, 33257466,\n33334705, 33403250, 33649865, 33933383", "firm_fei_number": "3005099803", "recalling_firm": "Boston Scientific Corporation", "address_1": "100 Boston Scientific Way", "city": "Marlborough", "state": "MA", "postal_code": "01752-1234", "additional_info_contact": "Renee Archie\n508-683-4000", "reason_for_recall": "Devices contain recalled Medline Namic Angiographic Control Syringe with Rotating Adaptor. There is a risk of syringe loosening or disconnecting from the manifold, resulting in loose connection or complete disconnection. May lead to difficulty connecting syringe, inability to aspirate or inject properly, fluid leakage, or separation of the syringe from the system, potentially requiring device exchange and prolonging the procedure.", "root_cause_description": "Under Investigation by firm", "action": "On June 30, 2026, the firm began notifying US customers via letters titled \"Urgent Medical Device Removal - Immediate Action Required.\"\n\nCustomers were instructed to immediately stop further use or distribution of affected product, and segregate it. Continue to follow the standard care when monitoring patients treated with the contact.\n\nProduct is to be returned to Boston Scientific.", "product_quantity": "153,921 (US); 119,274 (OUS)", "distribution_pattern": "US Nationwide distribution. OUS consignee list pending.", "openfda": { "k_number": [ "K102563", "K813027", "K801573", "K952406", "K974288", "K821530", "K905365", "K905173", "K931946", "K924517", "K810209", "K830572", "K881020", "K780794", "K890728", "K952407", "K960725", "K092022", "K894470", "K884749", "K991254", "K940371", "K903759", "K884786", "K964833", "K810251", "K902854", "K931912", "K924809", "K896800", "K050797", "K791998", "K960212", "K982435", "K883338", "K883506", "K201877", "K900208", "K933171", "K803200", "K930610" ], "registration_number": [ "3016707060", "3009937681", "3008384335", "1928237", "1422443", "3013298431", "9610612", "1420054", "3007060769", "8040179", "1423507", "3013443304", "3015277818", "9710020", "3008693658", "3018074706", "3005245797", "3004468406", "2183650", "8043685", "3010707607", "3018503755", "8010418", "3026844237", "3013506123", "3009104075", "1037752", "3009746061", "3004215929", "3000215556", "3005202235", "3009499159", "3015456958", "3014579161", "3008719222", 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"3003499455", "3004550973", "1035907", "3003418325", "3017896419", "3006897996", "3009308092", "3020468145", "7252", "1526854", "3012416077", "3033589330", "3033536319", "1216677", "3000183921", "1220477", "3003052153", "3017770710", "3016734024", "3002806816", "1250045", "3002807798", "3005934752", "3009420598", "3010177471", "1000121056", "1832653", "3013496867", "3015173212", "3014570560", "3009307523", "3005734757", "3014334038", "3003887292", "3030525551", "2183425", "3014637079", "1000123180", "3014252464", "3003413553", "3010380518", "3004216008", "1825034", "3010889742", "3004365956", "3005273623", "3010683450", "3014159736", "3007963782", "3007681502" ], "device_name": "Syringe, Irrigating (Non Dental)", "medical_specialty_description": "General Hospital", "regulation_number": "880.6960", "device_class": "1" } } ] }