Halyard CATH LAB Kit Recall Issued by AVID Medical

Source: FDA · United States

Areazine synthesizes this FDA recall directly from FDA's official public data feed. See our methodology for full source attribution and refresh cadence.

AVID Medical, Inc. is recalling 172 Halyard CATH LAB kits (model SACL75-01) distributed to seven U.S. 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, medical-device) 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 CATH LAB 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 172 kits of the Halyard CATH LAB kit, model number SACL75-01. Affected UDI (Kit Lot Numbers) include: (01)20809160481377(17)280520(10)341730(30)004(241)UINR44-01 (341730), (01)20809160481377(17)280623(10)341742(30)004(241)SACL75-01 (341742), (01)20809160481377(17)280609(10)345855(30)004(241)SACL75-01 (345855), and (01)20809160481377(17)280609(10)345863(30)004(241)SACL75-01 (345863). Distribution was limited to Florida, Illinois, Missouri, Mississippi, North Carolina, Nebraska, and Texas.

What You Should Do

The recall was initiated voluntarily by the firm via email on March 13, 2026. Customers with affected products should follow instructions provided by AVID Medical, Inc.

Why This Matters

This is an FDA Class I recall, indicating a reasonable probability of serious adverse health consequences from the potential device disconnection during use.

Source

FDA Enforcement Report, recall number Z-1974-2026. https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

Original source: FDA Official Notice ↗

All FDA Recalls →

Frequently Asked Questions

Common questions about this FDA recall.

What is this FDA recall about?
AVID Medical, Inc. is recalling 172 Halyard CATH LAB kits (model SACL75-01) distributed to seven U.S. 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.