FDA Medical devices recall ·
Convenience kits containing Medline Namic Angiographic Control Syringes… recall
This is an FDA Class I recall — the most serious type.
- Recall number
- Z-1981-2026
- Date
- (initiated March 19, 2026)
- Company / brand
- American Contract Systems Inc
85 Shaffer Park Dr, Tiffin, OH, United States - Category
- Medical devices › Class I
- Classification
- Class I
- Status
- Ongoing
- Units affected
- 7,311 kits
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
Product
Convenience kits containing Medline Namic Angiographic Control Syringes with Rotating Adaptor CORONARY ANGIO PACK Model numbers ANCA80AP ANCA80AQ
Why was it recalled?
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.
What should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
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.
States: Minnesota
What does Class I mean?
Class I is the most serious FDA recall class: there is a reasonable probability that using or being exposed to the product will cause serious adverse health consequences or death.
Source: FDA (medical devices), recall Z-1981-2026. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.