FDA Medical devices recall ·
Rapid Refill Continuous Injection System, UPN M00566001 recall
- Recall number
- Z-2725-2026
- Date
- (initiated June 30, 2026)
- Company / brand
- Boston Scientific Corporation
100 Boston Scientific Way, Marlborough, MA, United States - Category
- Medical devices › Class II
- Classification
- Class II
- Status
- Ongoing
- Units affected
- 153,921 (US); 119,274 (OUS)
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
Product
Rapid Refill Continuous Injection System, UPN M00566001
Why was it recalled?
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 should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
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, 3461661
Distribution
US Nationwide distribution. OUS consignee list pending.
What does Class II mean?
Class II means use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or the probability of serious harm is remote.
Source: FDA (medical devices), recall Z-2725-2026. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.