FDA Device recall Z-2138-2026
Namic Angiographic Manifold, custom, Medline Product Number/SKU 64038200
- 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 64038200 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-2138-2026 |
| 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 64038200; 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 10193489059144, UDI/Di case 30193489059148, Lot Numbers: 90184, 94779, 97786, 106351, 108597, 109876, 1140…UDI/DI each 10193489059144, UDI/Di case 30193489059148, Lot Numbers: 90184, 94779, 97786, 106351, 108597, 109876, 114056, 114989, 115459, 115931, 116358, 116865, 118245, 122974, 126077, 127795, 129531, 130557, 136114, 150501, 151591, 152772, 154514, 156045, 160318, 163255, 168053. |
|---|
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-2138-2026%22
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