Halyard Convenience Kits Recall Due to Particulates
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AVID Medical, Inc. is recalling 5,168 Halyard convenience kits containing Medline Namic Angiographic Star Off Handle Manifolds due to particulates in the fluid path.
What this FDA recall tells you, and what most readers miss
This notice was issued by FDA on August 18, 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, Devices.
What Happened
AVID Medical, Inc. initiated a voluntary recall of Halyard convenience kits because they contain Medline Namic Angiographic Star Off Handle Manifolds recalled due to presence of particulates within the fluid path of the Manifolds. Particulate within the fluid path has the potential to be introduced into blood circulation and become lodged within blood vessels.
Which Products Are Affected
The affected products are Halyard convenience kits containing recalled Medline Namic Angiographic Star Off Handle Manifolds, specifically SAMMC ANGIOGRAPHY SAMM066-15. A total of 5,168 kits are involved. The kits have UDI-DI 10809160388495 and the following lots: 1561685, 1575926, 1583048, 1584017, 1589652, 1595715, 1599634, 1605749, 1611810, 1621476, 1637222, 1637224, 1637225, 1643118, 1645143, 1645637, 1663929, 1663930, 1663931, 1663932. Distribution was nationwide in the United States, including the states of NC and TX. Recall number Z-2797-2026. Classification: Class I.
What You Should Do
The recalling firm, AVID Medical, Inc., provided initial notification via email, fax, letter, press release, telephone, and visit. Consumers should refer to the FDA recall notice for further guidance.
Why This Matters
This Class I recall involves a device with the potential for particulates to lodge within blood vessels.
Source
FDA recall Z-2797-2026, event ID 99339.
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 (1,393 characters here).
Similar severity timing
Same severity (high) notices issued closest in time to August 18, 2026.
Frequently Asked Questions
Common questions about this FDA recall.