FDA Medical devices recall ·
Halyard CATH LAB kit recall
This is an FDA Class I recall — the most serious type.
- Recall number
- Z-1974-2026
- Date
- (initiated March 13, 2026)
- Company / brand
- AVID Medical, Inc.
9000 Westmont Dr, Toano, VA, United States - Category
- Medical devices › Class I
- Classification
- Class I
- Status
- Ongoing
- Units affected
- 172 kits
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
Product
Halyard CATH LAB kit. Model Number: SACL75-01.
Why was it recalled?
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.
What should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
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.
States: Florida Illinois Missouri Mississippi North Carolina Nebraska Texas
What does Class I mean?
Class I is the most serious FDA recall class: there is a reasonable probability that using or being exposed to the product will cause serious adverse health consequences or death.
Source: FDA (medical devices), recall Z-1974-2026. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.