FDA recall Z-2148-2026

Medline Industries, LP · Class I · device

Product

Medline medical convenience kits, containing Namic Manifold, Labeled as: TAVI, Medline Kit Number/SKU DYNJ904981C

Reason for recall

Medline has identified the presence of particulate within the fluid path of the Manifolds.

Distribution

US (nationwide) and AE, AU, CA, JP, KR, NL, SG, SK.

Key facts

Status
Ongoing
Initiation date
2026-03-24
Report date
2026-05-20
Voluntary/Mandated
Voluntary: Firm initiated
Location
Northfield, IL, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2148-2026