Medline medical convenience kits recall (Medline Industries, LP)
Medical deviceClass IOngoing
Summary: Medline Industries, LP is recalling Medline medical convenience kits, containing Namic Manifold, Labeled as: TAVI, Medline Kit Number/SKU DYNJ904981C. Reason: Medline has identified the presence of particulate within the fluid path of the Manifolds.
What is being recalled
Medline medical convenience kits, containing Namic Manifold, Labeled as: TAVI, Medline Kit Number/SKU DYNJ904981C
Why
Medline has identified the presence of particulate within the fluid path of the Manifolds.
How serious is it
Class I is the most serious level: FDA considers there is a reasonable probability that using or being exposed to this product will cause serious health problems or death.
Where it was sold
US (nationwide) and AE, AU, CA, JP, KR, NL, SG, SK. (states named: California)
How to tell if yours is affected
UDI/DI each 10193489475135, UDI/DI case 40193489475136, Lot Numbers: 23GBR742, 23IBC951, 23JBM554, 23LBK506, 24BBO670, 24GBM624.
What to do
Check the model, lot or serial numbers above against your device. If yours is affected, contact the manufacturer or your healthcare provider before you stop using a device you rely on.
Recall facts
| Recall number | Z-2148-2026 |
| Category | Medical device |
| Agency | U.S. Food and Drug Administration (FDA) |
| Severity | Class I |
| Status | Ongoing |
| Recall started | March 24, 2026 |
| Reported | May 20, 2026 |
| Company | Medline Industries, LP |
| Company location | Northfield, IL, United States |
| Initiated by | Voluntary: Firm initiated |
| Quantity | 107 kits |
More recalls from Medline Industries, LP · all medical device recalls · recalls from March 2026