Namic Angiographic Manifold recall (Medline Industries, LP)
Medical deviceClass IOngoing
Summary: Medline Industries, LP is recalling Namic Angiographic Manifold, custom, Medline Product Number/SKU 64038301; Cardiopulmonary bypass adaptor, stopcock, manifold, or fitting.. Reason: Medline has identified the presence of particulate within the fluid path of the Manifolds.
What is being recalled
Namic Angiographic Manifold, custom, Medline Product Number/SKU 64038301; Cardiopulmonary bypass adaptor, stopcock, manifold, or fitting.
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 10193489059168, UDI/DI case 30193489059162, Lot Numbers: 89631, 92244, 92464, 93148, 94033, 94851, 101093, 101989, 103550, 109976, 112236, 112333, 114288, 115691, 121707, 126993, 137933, 142147, 162786, 191812,
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-2139-2026 |
| 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 | 38175 units |
More recalls from Medline Industries, LP · all medical device recalls · recalls from March 2026