Official recall notice
FDA DeviceClass INotable
Namic Angiographic Manifold custom Recall (May 2026)
Product: Namic Angiographic Manifold, custom, Medline Product Number/SKU 64038301; Cardiopulmonary bypass adaptor, stopcock, manifold, or fitting.
- Recall date
- 2026-05-20
- Category
- Medical Device
- FDA class
- Class I
Why it was recalled
Hazard
Medline has identified the presence of particulate within the fluid path of the Manifolds.
Product description
Medline has identified the presence of particulate within the fluid path of the Manifolds.