FDAFDA · Food and drugs·Recall number Z-2148-2026
Medline medical convenience kits, containing Namic Manifold, Labeled as: TAVI, Medline Kit Number/SKU DYNJ904981C
Published May 20, 2026 · Recall initiated: March 24, 2026
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Medline has identified the presence of particulate within the fluid path of the Manifolds.
What to do
Voluntary: Firm initiated · Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Recall details
- Manufacturer
- Medline Industries, LP
- Distributor
- US (nationwide) and AE, AU, CA, JP, KR, NL, SG, SK.
- Lot
- UDI/DI each 10193489475135, UDI/DI case 40193489475136, Lot Numbers: 23GBR742, 23IBC951, 23JBM554, 23LBK506, 24BBO670, 24GBM624.
- Risk classification
- Class I
- Area (FDA)
- device
- Country
- United States
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