Halyard Cardiac Cath Pack Recall Due to Particulates
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 5,168 Halyard convenience kits containing Medline Namic Angiographic Star Off Handle Manifolds due to potential particulates in the fluid path.
What this FDA recall tells you, and what most readers miss
This notice was issued by FDA on August 19, 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 verify its scope, source, and timestamp, then compare related notices without assuming that one record proves a broader trend.
Areazine pairs this record with the original agency URL so you can check the primary source before acting. Its related labels are recall, product-safety, fda, medical-device.
What Happened
AVID Medical, Inc. initiated a voluntary recall of Halyard convenience kits after determining they contain Medline Namic Angiographic Star Off Handle Manifolds recalled by the manufacturer due to the presence of particulates within the fluid path of the manifolds. Particulates have the potential to be introduced into blood circulation and become lodged within blood vessels.
Which Products Are Affected
The recall affects CARDIAC CATH PACK EAMC1000-05 kits (UDI-DI 10809160377314) with lots 1573593, 1583827, 1609541, 1612134, 1612516, 1619132, 1623384, 1627013, 1635459, 1672306, and 1675159. A total of 5,168 kits were distributed nationwide in the United States, including the states of NC and TX. The recall number is Z-2796-2026 and it is classified as Class I.
What You Should Do
Consumers and healthcare facilities should follow guidance from AVID Medical, Inc. regarding the recalled kits.
Why This Matters
Class I recalls indicate a reasonable probability that use of the device could cause serious adverse health consequences or death.
Source
FDA recall Z-2796-2026 (event ID 99339), https://www.fda.gov
Original source: FDA Official Notice ↗
Related FDA Recalls
All FDA Recalls →Nationwide notices with similar length or severity timing 8
Two Areazine-derived peer sets for this FDA recall: nearest notices by body length and by same severity near the same agency date. Peers come from other categories so they are not the same-feed Related list above.
Similar body length
Nearest notices by article body length (1,148 characters here).
Similar severity timing
Same severity (high) notices issued closest in time to August 19, 2026.
Frequently Asked Questions
Common questions about this FDA recall.