FDAClass I · Medical device · Recalled May 13, 2026

Convenience kits containing Medline Namic Angiographic Control Syringes with Rotating Adap recall — American Contract Systems Inc

Hazard: Impacted kits contain syringes recalled by Medline Industries. Syringe rotating adaptor may unwind during use, which may result in a loose connection or full disconnection between the syringe and manifold. Potential risk for biohazard exposure, blood loss, infection, or air embolism.

Class I: most serious — reasonable probability of serious health consequences or death.

View the official FDA enforcement record (openFDA) ↗

Official recall ID: Z-1981-2026
Brand: American Contract Systems
Classification: Class I
Units affected: 7,311 kits
Recall status: Ongoing
Initiated: Voluntary: Firm initiated

Description

Convenience kits containing Medline Namic Angiographic Control Syringes with Rotating Adaptor CORONARY ANGIO PACK Model numbers ANCA80AP ANCA80AQ

Affected products

Convenience kits containing Medline Namic Angiographic Control Syringes with Rotating Adap

Companies & origin

Recalling firm location: Tiffin, OH, United States
Firm address: 85 Shaffer Park Dr, 44883-9290

Identifying details (verbatim from the notice)

Product codes / lots: ANCA80AP UDI-DI 191072232168 Lot 42-8146111 ANCA80AQ UDI-DI 191072236678 Lots 42-8207211 42-8267711 42-8311311 42-8337611 42-8353311 42-8379211 42-8407111 42-8510711 42-8575111 42-8611511 42-8718911 42-8718912 42-8722611 42-8805311 42-8820611 42-8870911
Distribution: US distribution to MN. No OUS distribution.
Firm notified the public via: E-Mail
FDA event ID: 98720
Recall initiated: March 19, 2026
FDA classified: May 6, 2026
FDA report date: May 13, 2026

Source: U.S. Food & Drug Administration. This page mirrors the official public-domain record verbatim; the linked government source is authoritative. Source last checked July 24, 2026 at 3:00 AM UTC.

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