Class II

Medical Device Recall: Rapid Refill Continuous Injection System, UPN M00566001

Boston Scientific Corporation · June 30, 2026

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.

Distribution

US Nationwide distribution. OUS consignee list pending.

States Affected

NATIONWIDE

Quantity Affected

153,921 (US); 119,274 (OUS)

Source: FDA (openFDA Device Enforcement)

Recall number: Z-2725-2026

Status: ongoing

SafeCheck provides drug interaction information from FDA-approved product labeling (openFDA). This is for informational purposes only and is not medical advice. Always consult your healthcare provider before making medication decisions.