Official recall notice
FDA DeviceClass INotable
Medline medical convenience kits Recall (May 2026)
Product: Medline medical convenience kits, containing Namic Manifold, Labeled as: TAVI, Medline Kit Number/SKU DYNJ904981C
- 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.