Reported May 20, 2026 · Ongoing
Medline medical convenience kits, containing Namic Manifold, Labeled as: TAVI, Medline Kit Number/SKU DYNJ904981C
Medline Industries, LP
High riskUsing this product could cause serious injury, illness or death — stop using it now.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Medline Industries, LP · 3 Lakes Dr · Northfield, IL · 60093-2753
Is this the product you have?
- Medline medical convenience kits, containing Namic Manifold
- Labeled asTAVI, Medline Kit Number/SKU DYNJ904981C
- Lot codes and dates
UDI/DI each 10193489475135UDI/DI case 40193489475136
- Lot Numbers
23GBR74223IBC95123JBM55423LBK50624BBO67024GBM624
- Amount recalled
- 107 kits
This recall covers 11 products
The agency filed one notice per product. You are reading one of them; the other 10 are below.
Where it was sold
- Nationwide
- CA
Why it was recalled
Stop using this product now
Medline has identified the presence of particulate within the fluid path of the Manifolds.
Using this product could cause serious injury, illness or death — stop using it now.
Want the full recall guide?
The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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