FDA Device recall Z-2139-2026
Namic Angiographic Manifold, custom, Medline Product Number/SKU 64038301
- FDA Device
- Class I
- ongoing
- Published 2026-05-20
On 2026-05-20 the FDA classified a Class I recall of Namic Angiographic Manifold, custom, Medline Product Number/SKU 64038301 by Medline Industries, citing medline has identified the presence of particulate within the fluid path of the Manifolds.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2139-2026 |
| Classification | Class I |
| Status | ongoing |
| Initiated | 2026-03-24 |
| Published | 2026-05-20 |
| Last updated | 2026-09-13 11:58 UTC |
| Company | Medline Industries |
| Distribution | US |
Product
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.
Identifiers
| code_info | UDI/DI each 10193489059168, UDI/DI case 30193489059162, Lot Numbers: 89631, 92244, 92464, 93148, 94033, 94851, 101093,…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, |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:58 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2139-2026%22
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