FDA Medical devices recall ·
Halyard HEART CATH, SELF REGIONAL kit recall
This is an FDA Class I recall — the most serious type.
- Recall number
- Z-1975-2026
- 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
- 2,932 kits
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
Product
Halyard HEART CATH, SELF REGIONAL kit. Model Number: SELF131-05.
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: SELF131-05. UDI-DI (Kit Lot Numbers): 10809160408650 (1611688, 1611689, 1618351, 1621441, 1627930, 1635908, 1644501, 1646021, 1651957, 1654887, 1656582, 1656581, 1659713, 1670884, 1670885, 1671950).
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-1975-2026. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.