CLASS I ONGOING Device recall · Reported 13 May 2026 · FDA Enforcement Report

Convenience kits containing Medline Namic Angiographic recalled

American Contract Systems is recalling Convenience kits containing Medline Namic Angiographic Control Syringes with Rotating, distributed in Minnesota. The recall was initiated on 19 Mar 2026 and the FDA has classified it as Class I.

Check your package

Lot, batch or date codesANCA80AP 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

Quantity recalled7,311 kits

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-1981-2026
FDA event ID: 98720
Recalling firm: American Contract Systems, Tiffin, OH
Classification: Class I
Status: Ongoing
Recall initiated: 19 Mar 2026
FDA classified: 6 May 2026
Reported: 13 May 2026
Type: Voluntary: Firm initiated
Customers notified by: E-Mail
Reason category: Other Reasons
Device type: Syringes & Needles

Timeline

19 Mar 2026	Recall initiated by company
6 May 2026	Classified by FDA	+48 days
13 May 2026	Published in enforcement report	+7 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

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.

Product as listed by the FDA

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

Where it was distributed

US distribution to MN. No OUS distribution.

Minnesota

Questions about this recall

Why was it recalled?

Which lots are affected?

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

Where was it sold?

US distribution to MN. No OUS distribution.

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class I mean?

Class I is the most serious FDA recall category: there is a reasonable probability that using the product will cause serious health consequences or death.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

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