Reported Jul 22, 2026 · Ongoing · Updated Sep 16, 2026
Rapid Refill Continuous Injection System, UPN M00566001
Boston Scientific Corporation
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Boston Scientific Corporation · 100 Boston Scientific Way · Marlborough, MA · 01752-1234
Is this the product you have?
- Rapid Refill Continuous Injection System, UPN M00566001
- Lot codes and dates
299 of 299 codes
UDI-DI (GTIN) 08714729285151 Lots 337866113382594933826026339499163396857133968575340799813415310434153413341534153420307534203077341534113420307934203115343866053438660934386613344296563442965834595249346935593461661334616615347124333476342734763967348057233480572534805729350069953500699935056793352089463518684535208950353973143520895235305436354980303544831635498028355515233562693935574463356881183568846035828714358317033584848335877768359952823604941536159194362198823629410036303614363322303117700631180206
- Amount recalled
- 153,921 (US); 119,274 (OUS)
Where it was sold
- Nationwide
Why it was 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.
This product could cause temporary or reversible health problems — stop using it.
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