Halyard Convenience 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 5,168 Halyard convenience kits due to particulates in contained Medline Namic Angiographic Star Off Handle Manifolds.
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, Devices.
What Happened
AVID Medical, Inc. initiated a voluntary recall of Halyard convenience kits containing recalled Medline Namic Angiographic Star Off Handle Manifolds. The manifolds were recalled due to the presence of particulates within the fluid path, which has the potential to be introduced into blood circulation and become lodged within blood vessels.
Which Products Are Affected
The recall involves Halyard convenience kits (product description: HEART CATH, SELF REGIONAL SELF131-05) with UDI-DI 10809160408650 and the following lots: 1618351, 1621441, 1627930, 1635908, 1644501, 1646021, 1651957, 1654887, 1656581, 1656582, 1659713, 1670884, 1670885, 1671950. A total of 5,168 kits were distributed nationwide in the United States, specifically in the states of NC and TX. The FDA recall number is Z-2798-2026 and the event ID is 99339. This is a Class I recall.
What You Should Do
Consumers and healthcare providers should follow the recalling firm's instructions regarding the affected kits. The recall was initiated by AVID Medical, Inc. of Toano, VA.
Why This Matters
Class I recalls indicate a reasonable probability that use of the device could cause serious adverse health consequences or death due to the risk of particulates entering the bloodstream.
Source
FDA Recall Z-2798-2026 - AVID Medical, Inc.
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 (1,357 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.