FDAFDA recall Z-2725-2026 · Jul 22, 2026

Boston Scientific Corporation: Rapid Refill Continuous Injection System recall

Recall found

Product

Rapid Refill Continuous Injection System, UPN M00566001

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.

What to do

FDA enforcement reports don't include consumer instructions. Check the codes below against your packaging. If this is a medicine or device you use, talk to your pharmacist or doctor before you stop or change anything, and contact the company or FDA for what to do with the product.

Recall details

FDA classification: Class II: use of or exposure to the product may cause temporary or medically reversible health problems, or the chance of serious problems is remote.
Status: Ongoing
Codes, lots and dates: 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)
Distribution: US Nationwide distribution. OUS consignee list pending.
Recalling firm: Boston Scientific Corporation, Marlborough, MA
Voluntary or mandated: Voluntary: Firm initiated
Recall started: 2026-06-30

Source: openFDA enforcement record Z-2725-2026 · search recall number Z-2725-2026 in FDA's Enforcement Report.

Copied from the agency record without changes. Data as of Oct 22, 2026, 4:56 AM EDT. The agency notice is the final word.