Halyard NEURO IR PERIPHERAL Kit Recall
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AVID Medical, Inc. recalls 204 Halyard NEURO IR PERIPHERAL kits due to potential syringe adaptor disconnection risk.
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.
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What Happened
AVID Medical, Inc. initiated a voluntary recall of Halyard NEURO IR PERIPHERAL (PS 64405) 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
Halyard NEURO IR PERIPHERAL (PS 64405) kit, Model Number: UINR44-01. 204 kits distributed to FL, IL, MO, MS, NC, NE, TX. Affected UDI (Kit Lot Numbers): (01)20809160484439(17)280201(10)340135(30)004(241)UINR44-01 (340135), (01)20809160484439(17)280201(10)340136(30)004(241)UINR44-01 (340136), (01)20809160454439(17)280201(10)340352(30)004(241)UINR44-01 (340352), (01)20809160484439(17)280201(10)349076(30)004(241)UINR44-01 (349076). Recall Number: Z-1976-2026. Class I recall.
What You Should Do
Consumers in possession of the affected products should follow instructions provided by the recalling firm.
Why This Matters
This Class I recall involves a medical device distributed across multiple U.S. states with a risk of device disconnection during use.
Source
FDA recall Z-1976-2026, https://www.fda.gov
Original source: FDA Official Notice ↗
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