FDA recall Z-2725-2026

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.

Distribution

US Nationwide distribution. OUS consignee list pending.

Key facts

Status

Ongoing

Initiation date

2026-06-30

Report date

2026-07-22

Voluntary/Mandated

Voluntary: Firm initiated

Location

Marlborough, MA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2725-2026