FDAClass I · Medical device · Recalled May 13, 2026
Halyard CATH LAB 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-1974-2026
- Brand
- AVID Medical
- Classification
- Class I
- Units affected
- 172 kits
- Recall status
- Ongoing
- Initiated
- Voluntary: Firm initiated
Description
Halyard CATH LAB kit. Model Number: SACL75-01.
Affected products
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: SACL75-01. UDI (Kit Lot Numbers): (01)20809160481377(17)280520(10)341730(30)004(241)UINR44-01 (341730), (01)20809160481377(17)280623(10)341742(30)004(241)SACL75-01 (341742), (01)20809160481377(17)280609(10)345855(30)004(241)SACL75-01 (345855), (01)20809160481377(17)280609(10)345863(30)004(241)SACL75-01 (345863).
- 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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