Halyard CARDIAC CATH TRAY SHANDS JAX Kits Recall
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 6,956 Halyard CARDIAC CATH TRAY SHANDS JAX kits 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 25, 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 TRAY SHANDS JAX kits due to a potential risk for Medline syringe rotating adaptor unwinding 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 TRAY SHANDS JAX kit
- Model Numbers: SHND401-04, SHND401-05
- Quantity: 6,956 kits
- Distribution: US distribution to FL, IL, MO, MS, NC, NE, TX
- Recall Number: Z-1972-2026
- Specific lot details are listed in the FDA recall entry under UDI-DI codes 10809160395615 and 10809160491294.
What You Should Do
Consumers and healthcare facilities should follow guidance from the recalling firm regarding the affected kits.
Why This Matters
This is a Class I recall, indicating a reasonable probability of serious adverse health consequences from use of the affected devices.
Source
FDA recall Z-1972-2026 (https://www.fda.gov)
Original source: FDA Official Notice ↗
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