FDAClass I · Medical device · Recalled May 13, 2026

Halyard NEURO IR PERIPHERAL (PS 64405) kit recall — AVID Medical, Inc.

Hazard: 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.

Class I: most serious — reasonable probability of serious health consequences or death.

View the official FDA enforcement record (openFDA) ↗

Official recall ID: Z-1976-2026
Brand: AVID Medical
Classification: Class I
Units affected: 204 kits
Recall status: Ongoing
Initiated: Voluntary: Firm initiated

Description

Halyard NEURO IR PERIPHERAL (PS 64405) kit. Model Number: UINR44-01.

Affected products

Halyard NEURO IR PERIPHERAL (PS 64405) kit

Companies & origin

Recalling firm location: Toano, VA, United States
Firm address: 9000 Westmont Dr, 23168-9351

Identifying details (verbatim from the notice)

Product codes / lots: Model Number: UINR44-01. UDI (Kit Lot Number): (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).
Distribution: US distribution to FL, IL, MO, MS, NC, NE, TX.
Firm notified the public via: E-Mail
FDA event ID: 98686
Recall initiated: March 13, 2026
FDA classified: May 1, 2026
FDA report date: May 13, 2026

Source: U.S. Food & Drug Administration. This page mirrors the official public-domain record verbatim; the linked government source is authoritative. Source last checked July 24, 2026 at 3:00 AM UTC.

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