{"recall":{"id":"fda-device-99336","source":"FDA","sourceName":"U.S. Food and Drug Administration (openFDA device enforcement)","cat":"medicines","kids":false,"kind":"device","title":"Boston Scientific Corporation recalls Rapid Refill Continuous Injection System","firm":"Boston Scientific Corporation","date":"2026-06-30","reported":"2026-07-22","status":"Ongoing","classification":"Class II","products":[{"name":"Rapid Refill Continuous Injection System, UPN M00566001","code":"UDI-DI (GTIN) 08714729285151 Lots 33786611, 33825949, 33826026, 33949916, 33968571, 33968575, 34079981, 34153104, 34153413, 34153415, 34203075, 34203077, 34153411, 34203079, 34203115, 34386605, 34386609, 34386613, 34429656, 34429658, 34595249, 34693559, 34616613, 34616615, 34712433, 34763427, 34763967, 34805723, 34805725, 34805729, 35006995, 35006999, 35056793, 35208946, 35186845, 35208950, 35397314, 35208952, 35305436, 35498030, 35448316, 35498028, 35551523, 35626939, 35574463, 35688118, 35688460, 35828714,35831703, 35848483, 35877768, 35995282, 36049415, 36159194, 36219882, 36294100, 36303614, 36332230, 31177006, 31180206, 31666278, 31329922, 31356107, 31666276, 31798400, 31798133, 31798135, 31798137, 31852246, 32162450, 32208753, 32255526, 32255528, 32496142, 32661870, 32696046, 32696050, 32696052, 32752697, 32773682, 32791475, 32791477, 32820865, 32838612, 32791479, 33119798, 32977346, 32977348, 33030942, 33120320, 33158008, 33158006, 33354311, 33354315, 33354317, 33403248, 33403252, 33696882, 33696884, 33696886, 33696888, 33750883, 33750885, 33750887, 36332232, 36497262, 36159192, 36587704, 36612263, 36739668, 36785215, 36785217, 36814560, 36845486, 36983883, 36983886, 37291592, 37059471, 37417957, 37417959, 37429808, 37456936, 37472523, 37585745, 37627037, 37654892, 37941477, 37974508, 38033021, 38033023, 38124799, 38143635, 38165214, 38182214, 38201123, 37959187, 38353956, 38374833, 38430201, 33968573, 34386611, 32838610, 38205377, 38429054, 34066207, 34429654, 34616611, 34712429, 34763971, 34805727, 35006997, 35448312, 35448314, 35626937, 35688021, 35848481, 35687399, 31616842, 31601573, 31616848, 31616850, 31616846, 32208755, 32455154, 35877766, 36776858, 37037796, 37200706, 37276220, 37291594, 37639238, 38154387, 35305438, 31797614, 33354313, 33696890, 36470789, 37309672, 37396601, 37407323, 37472521, 35056797, 35626933, 33786613, 33825951, 33950422, 34965218, 35056795, 36101020, 36100418, 31356105, 32208759, 32661868, 33030940, 33679650, 37059473, 37041524, 37633157, 37991645, 38137850, 38393609, 33968569, 34703963, 36319481, 33649863, 37019542, 37493275, 34616609, 34386607, 34763969, 34805721, 35942747, 31852244, 32977350, 33354319, 37884043, 38001944, 32752695, 37189280, 37612931, 38703180, 34429700, 33968567, 34017321, 34568306, 34712431, 34873735, 34873737, 34965420, 35007081, 35186843, 35208948, 35397312, 35448310, 35305600, 35626935, 35778515, 35778517, 35778513, 35989120, 36027670, 36049413, 36303612, 36319483, 36312073, 36353951, 36437019, 36517931, 36409546, 36537384, 36622267, 36750117, 36750119, 36994750, 36962014, 37407325, 37456934, 37766480, 37660978, 37764898, 37723376, 37991643, 38856580, 38178214, 38337853, 38326961, 38410111, 38414293, 38576233, 38586789, 38622115, 38633220, 38676778, 38649491, 38680582, 38864691, 38687308, 38876174, 38901702, 31170922, 31601571, 31616844, 31852242, 31852240, 32162448, 32208757, 32696048, 32723872, 32723874, 32838608, 32964550, 32977344, 33119794, 33119796, 33257466, 33334705, 33403250, 33649865, 33933383","quantity":"153,921 (US); 119,274 (OUS)","number":"Z-2725-2026","classification":"Class II"}],"reason":"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.","hazard":"FDA Class II: may cause temporary or medically reversible adverse health consequences (FDA definition).","affected":"US Nationwide distribution. OUS consignee list pending.","nationwide":true,"states":[],"units":"153,921 (US); 119,274 (OUS)","remedy":"","whatToDo":"Check your product against the names and codes above. The FDA enforcement record lists the recall as voluntary: firm initiated; it does not state a consumer remedy, so follow the firm’s notice or the FDA link.","contact":"","url":"https://www.accessdata.fda.gov/scripts/ires/index.cfm?Event=99336","apiUrl":"https://api.fda.gov/device/enforcement.json?search=report_date:[20260705+TO+20991231]&sort=report_date:desc&limit=1000","rawHash":"473438a1f2de7874","firstSeen":"2026-11-02T13:57:14.206Z","updatedAt":"2026-11-02T13:57:14.206Z","history":[]},"official":{"fetchedAt":"2026-11-02T13:57:14.206Z","apiUrl":"https://api.fda.gov/device/enforcement.json?search=report_date:[20260705+TO+20991231]&sort=report_date:desc&limit=1000","officialUrl":"https://www.accessdata.fda.gov/scripts/ires/index.cfm?Event=99336","record":[{"status":"Ongoing","city":"Marlborough","state":"MA","country":"United States","classification":"Class II","openfda":{},"product_type":"Devices","event_id":"99336","recalling_firm":"Boston Scientific Corporation","address_1":"100 Boston Scientific Way","address_2":"","postal_code":"01752-1234","voluntary_mandated":"Voluntary: Firm initiated","initial_firm_notification":"Letter","distribution_pattern":"US Nationwide distribution. OUS consignee list pending.","recall_number":"Z-2725-2026","product_description":"Rapid Refill Continuous Injection System, UPN M00566001","product_quantity":"153,921 (US); 119,274 (OUS)","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.","recall_initiation_date":"20260630","center_classification_date":"20260710","report_date":"20260722","code_info":"UDI-DI (GTIN) 08714729285151  Lots  33786611, 33825949, 33826026, 33949916, 33968571, 33968575, 34079981, 34153104, 34153413, 34153415, 34203075, 34203077, 34153411, 34203079, 34203115, 34386605, 34386609, 34386613, 34429656, 34429658, 34595249, 34693559, 34616613, 34616615, 34712433, 34763427, 34763967, 34805723, 34805725, 34805729, 35006995, 35006999, 35056793, 35208946, 35186845, 35208950, 35397314, 35208952, 35305436, 35498030, 35448316, 35498028, 35551523, 35626939, 35574463, 35688118, 35688460, 35828714,35831703, 35848483, 35877768, 35995282, 36049415, 36159194, 36219882, 36294100, 36303614, 36332230, 31177006, 31180206, 31666278, 31329922, 31356107, 31666276, 31798400, 31798133, 31798135, 31798137, 31852246, 32162450, 32208753, 32255526, 32255528, 32496142, 32661870, 32696046, 32696050, 32696052, 32752697, 32773682, 32791475, 32791477, 32820865, 32838612, 32791479, 33119798, 32977346, 32977348, 33030942, 33120320, 33158008, 33158006, 33354311, 33354315, 33354317, 33403248, 33403252, 33696882, 33696884, 33696886, 33696888, 33750883, 33750885, 33750887, 36332232, 36497262, 36159192, 36587704, 36612263, 36739668, 36785215, 36785217, 36814560, 36845486, 36983883, 36983886, 37291592, 37059471, 37417957, 37417959, 37429808, 37456936, 37472523, 37585745, 37627037, 37654892, 37941477, 37974508, 38033021, 38033023, 38124799, 38143635, 38165214, 38182214, 38201123, 37959187, 38353956, 38374833, 38430201, 33968573, 34386611, 32838610, 38205377, 38429054, 34066207, 34429654, 34616611, 34712429, 34763971, 34805727, 35006997, 35448312, 35448314, 35626937, 35688021, 35848481, 35687399, 31616842, 31601573, 31616848, 31616850, 31616846, 32208755, 32455154, 35877766, 36776858, 37037796, 37200706, 37276220, 37291594, 37639238, 38154387, 35305438, 31797614, 33354313, 33696890, 36470789, 37309672, 37396601, 37407323, 37472521, 35056797, 35626933, 33786613, 33825951, 33950422, 34965218, 35056795, 36101020, 36100418, 31356105, 32208759, 32661868, 33030940, 33679650, 37059473, 37041524, 37633157, 37991645, 38137850, 38393609, 33968569, 34703963, 36319481, 33649863, 37019542, 37493275, 34616609, 34386607, 34763969, 34805721, 35942747, 31852244, 32977350, 33354319, 37884043, 38001944, 32752695, 37189280, 37612931, 38703180, 34429700, 33968567, 34017321, 34568306, 34712431, 34873735, 34873737, 34965420, 35007081, 35186843, 35208948, 35397312, 35448310, 35305600, 35626935, 35778515, 35778517, 35778513, 35989120, 36027670, 36049413, 36303612, 36319483, 36312073, 36353951, 36437019, 36517931, 36409546, 36537384, 36622267, 36750117, 36750119, 36994750, 36962014, 37407325, 37456934, 37766480, 37660978, 37764898, 37723376, 37991643, 38856580, 38178214, 38337853, 38326961, 38410111, 38414293, 38576233, 38586789, 38622115, 38633220, 38676778, 38649491, 38680582, 38864691, 38687308, 38876174, 38901702, 31170922, 31601571, 31616844, 31852242, 31852240, 32162448, 32208757, 32696048, 32723872, 32723874, 32838608, 32964550, 32977344, 33119794, 33119796, 33257466, 33334705, 33403250, 33649865, 33933383","more_code_info":""}]}}