Halyard HEART CATH — Class I medical device recall Z-1975-2026
Ongoing recall by AVID Medical, Inc., reported 2026-05-13, distributed in FL, IL, MO, MS, NC, NE, TX. Potential risk for Medline syringe rotating adaptor unwinding during use, which may result in a loose connecti
| Recall number | Z-1975-2026 |
|---|---|
| Product type | Medical device |
| Classification | Class I |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | AVID Medical, Inc., Toano, VA, United States |
| Recall initiated | 2026-03-13 |
| Classified | 2026-05-01 |
| Reported by FDA | 2026-05-13 |
| Distributed | FL, IL, MO, MS, NC, NE, TX |
| Quantity | 2,932 kits |
| UPC / GTIN / UDI-DI | 10809160408650 |
| Lot numbers | 1611689, 1618351, 1621441, 1627930, 1635908, 1644501, 1646021, 1651957, 1654887, 1656581, 1656582, 1659713, 1670884, 1670885 |
| Model numbers | SELF131-05 |
Product
Halyard HEART CATH, SELF REGIONAL kit. Model Number: SELF131-05.
Reason for recall
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1975-2026. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.