Halyard CARDIAC CATH PACK Recall Issued by AVID Medical

Source: FDA · United States

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AVID Medical, Inc. is recalling 180 Halyard CARDIAC CATH PACK SAN23CARDQ kits (model DRCC36) distributed to seven states due to a potential syringe disconnection hazard.

What this FDA recall tells you, and what most readers miss

This notice was issued by FDA on May 26, 2026 and geographically references United States. Its severity classification of "high" signals how the issuing agency weighs the risk of harm if no action is taken - "critical" and "high" tier alerts typically carry direct consumer actions, while "medium" and "low" tend toward informational guidance or monitoring advisories. The category it belongs to - FDA Recalls - determines the consumer-protection framework behind it, which shapes what remedies (refunds, replacements, repairs, or the recall itself) are available to affected consumers and which agency holds statutory responsibility for enforcement.

Most readers skim a notice like this, check whether they are personally affected, and move on. The more useful lens is to read it as a data point about the issuing system: how quickly FDA detected the hazard, how precise the geographic or product-identifier scope is, and whether similar notices have clustered in the same category or region in the last 90 days. Cluster patterns frequently precede a broader regulatory action, a single localized FDA recall is isolated; three of them within a quarter often indicate a supply-chain, infrastructure, or seasonal driver that will keep producing notices until something structural changes.

For decision-making, Areazine pairs each alert with the original agency URL, the full agency name, and a timestamp so you can verify the notice against the primary source before acting on it. Tags on this item (recall, product-safety, fda, Devices) map to related alerts in the same area of risk - browsing them together gives a clearer picture than any single notice alone, because the shape of an ongoing issue only becomes visible across multiple sequential alerts.

What Happened

AVID Medical, Inc. initiated a voluntary recall of Halyard CARDIAC CATH PACK SAN23CARDQ kits after identifying a potential risk that the Medline syringe rotating adaptor may unwind during use, resulting in a loose connection or full disconnection between the syringe and manifold.

Which Products Are Affected

The recall covers 180 kits of the Halyard CARDIAC CATH PACK SAN23CARDQ kit, model number DRCC36. Affected lot information includes UDI-DI 10809160469088 (lot 1659651). Distribution was limited to Florida, Illinois, Missouri, Mississippi, North Carolina, Nebraska, and Texas.

What You Should Do

Consumers and healthcare facilities should immediately stop using the affected kits and contact AVID Medical, Inc. for return or refund instructions. The recall was initiated via email on March 13, 2026.

Why This Matters

This Class I recall addresses a defect that could compromise device connections during cardiac catheterization procedures.

Source

FDA recall number Z-1971-2026 (event ID 98686).

Original source: FDA Official Notice ↗

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Frequently Asked Questions

Common questions about this FDA recall.

What is this FDA recall about?
AVID Medical, Inc. is recalling 180 Halyard CARDIAC CATH PACK SAN23CARDQ kits (model DRCC36) distributed to seven states due to a potential syringe disconnection hazard.
Which agency issued this alert?
This alert was issued by FDA. The original notice is available at the source link at the bottom of this article.
How severe is this alert?
This alert is classified as "high" severity. Take precautions and monitor for updates.
What area is affected?
This alert affects United States. Check with FDA for the most current geographic scope.
Where can I find more FDA Recalls updates?
Browse the full FDA Recalls feed on Areazine at areazine.com/recalls/fda/ for the latest updates from FDA and other agencies.