Rapid Refill Continuous Injection System recall (Boston Scientific Corporation)
Medical deviceClass IIOngoing
Summary: Boston Scientific Corporation is recalling Rapid Refill Continuous Injection System, UPN M00566001. 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.
What is being recalled
Rapid Refill Continuous Injection System, UPN M00566001
Why
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.
How serious is it
Class II is the middle level: using or being exposed to this product may cause temporary or medically reversible health problems, and the chance of serious harm is remote.
Where it was sold
US Nationwide distribution. OUS consignee list pending.
How to tell if yours is affected
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
What to do
Check the model, lot or serial numbers above against your device. If yours is affected, contact the manufacturer or your healthcare provider before you stop using a device you rely on.
Recall facts
| Recall number | Z-2725-2026 |
| Category | Medical device |
| Agency | U.S. Food and Drug Administration (FDA) |
| Severity | Class II |
| Status | Ongoing |
| Recall started | June 30, 2026 |
| Reported | July 22, 2026 |
| Company | Boston Scientific Corporation |
| Company location | Marlborough, MA, United States |
| Initiated by | Voluntary: Firm initiated |
| Quantity | 153,921 (US); 119,274 (OUS) |
More recalls from Boston Scientific Corporation · all medical device recalls · recalls from June 2026