Agency classClass IOur severity:Severe FDA (Devices)·Z-1981-2026·Announced 2026-05-13

Coronary angio packs recalled over Medline syringe rotating adaptor defect

Coronary angio convenience kits are being recalled because they contain Medline Namic syringes whose rotating adaptor may unwind, risking disconnection from the manifold.

The agency’s classification

FDA (Devices): Class I

Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 4/5 (Severe).

The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: FDA Class I recall, which the rubric floors at Severe; no death is reported in the source, so it does not escalate to Critical.

Plain-English summary

Convenience kits containing Medline Namic Angiographic Control Syringes with Rotating Adaptor, sold as CORONARY ANGIO PACK under model numbers ANCA80AP and ANCA80AQ, are being recalled. The action covers 7,311 kits.

The impacted kits contain syringes recalled by Medline Industries. The syringe rotating adaptor may unwind during use, which may result in a loose connection or full disconnection between the syringe and the manifold. According to the notice, this creates a potential risk for biohazard exposure, blood loss, infection or air embolism. The FDA classified the action as Class I, its most serious classification.

Distribution was within the United States, to Minnesota. There was no distribution outside the United States. The kits are supplied to healthcare facilities rather than sold to consumers.

Facilities should identify affected kits using the model numbers, UDI-DI codes and lot numbers in the recall notice, quarantine any stock on hand, and follow the instructions issued by the manufacturer.

The recalled product

Product: Convenience kits containing Medline Namic Angiographic Control Syringes with Rotating Adaptor CORONARY ANGIO PACK Model numbers ANCA80AP ANCA80AQ
Manufacturer: American Contract Systems Inc
Category: Medical Device — Angiography convenience kit
Hazard: disconnection-risk
syringe-adaptor
class-i
air-embolism-risk
blood-loss
Affected units: 7,311

Distribution

Distributed in 1 state:

Same manufacturer · American Contract Systems Inc

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Same hazard · disconnection risk