Halyard CARDIAC CATH PACK Kits Recall Issued

Source: FDA · United States

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AVID Medical, Inc. is recalling 222 Halyard CARDIAC CATH PACK kits distributed to seven U.S. states due to potential syringe disconnection risk.

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.

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What Happened

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

Which Products Are Affected

  • Product: Halyard CARDIAC CATH PACK kit
  • Model Numbers: EAMC1000-05, WAFB208-02
  • Quantity: 222 kits
  • Distribution: US distribution to FL, IL, MO, MS, NC, NE, TX
  • Lot details:
    • EAMC1000-05: UDI-DI 10809160377314 (lots 1573593, 1583827, 1609541, 1609725, 1612134, 1612516, 1619132, 1623384, 1627013, 1635459, 1672306, 1675159)
    • WAFB208-02: UDI-DI 10809160424759 (lots 1615954, 1653009)
  • Recall Number: Z-1970-2026
  • Classification: Class I
  • Recall Initiation Date: March 13, 2026

What You Should Do

Consumers in possession of the affected kits should stop using them and follow instructions provided by AVID Medical, Inc. regarding return or disposal.

Why This Matters

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

Source

FDA Enforcement Report, Recall Number Z-1970-2026 (https://www.fda.gov)

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 222 Halyard CARDIAC CATH PACK kits distributed to seven U.S. states due to potential syringe disconnection risk.
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.