Data Foundry

Medical device recalls 2026

Halyard convenience kits containing recalled Medline Namic… — Class I medical device recall Z-2798-2026

Ongoing recall by AVID Medical, Inc., reported 2026-08-12, distributed nationwide. Affected kits contain Medline Namic Angiographic Star Off Handle Manifolds, which were recalled by the manufac

Recall numberZ-2798-2026
Product typeMedical device
ClassificationClass I
StatusOngoing
Voluntary or mandatedVoluntary
Recalling firmAVID Medical, Inc., Toano, VA, United States
Recall initiated2026-04-30
Classified2026-07-31
Reported by FDA2026-08-12
DistributedNationwide (US)
Quantity5,168 kits
Reason classesspecification failure
UPC / GTIN / UDI-DI10809160408650
Lot numbers1618351, 1621441, 1627930, 1635908, 1644501, 1646021, 1651957, 1654887, 1656581, 1656582, 1659713, 1670884, 1670885, 1671950

Product

Halyard convenience kits containing recalled Medline Namic Angiographic Star Off Handle Manifolds. HEART CATH, SELF REGIONAL SELF131-05

Reason for recall

Affected kits contain Medline Namic Angiographic Star Off Handle Manifolds, which were recalled by the manufacturer due to presence of particulates within fluid path of the Manifolds. Particulate within the fluid path has the potential to be introduced into blood circulation and become lodged within blood vessels.

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-2798-2026. 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.