FDA Device recall Z-2143-2026
Medline medical convenience kits, containing Namic Manifold, Labeled as: 1. ANGIOGRAPHY CATH LAB, Medline Kit Number/SKUDYNJ23532C
- FDA Device
- Class I
- ongoing
- Published 2026-05-20
On 2026-05-20 the FDA classified a Class I recall of Medline medical convenience kits, containing Namic Manifold, Labeled as: 1. ANGIOGRAPHY CATH LAB, Medline Kit Number/SKUDYNJ23532C 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-2143-2026 |
| 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
Medline medical convenience kits, containing Namic Manifold, Labeled as: 1. ANGIOGRAPHY CATH LAB, Medline Kit Number/SKUDYNJ23532C; 2. CATH LAB PACK, Medline Kit Number/SKUDYNJ65185; 3. ANGIO KIT, Medline Kit Number/SKUVASC1057.
Reason
Medline has identified the presence of particulate within the fluid path of the Manifolds.
Identifiers
| code_info | Medline Kit Number/SKU DYNJ23532C: UDI/DI each 10193489460872, UDI/DI case 40193489460873, Lot Number: 25DMA809; Medl…Medline Kit Number/SKU DYNJ23532C: UDI/DI each 10193489460872, UDI/DI case 40193489460873, Lot Number: 25DMA809; Medline Kit Number/SKU DYNJ65185: UDI/DI each 10193489253146, UDI/DI case 40193489253147, Lot Number: 23GBA252; Medline Kit Number/SKU DYNJ65185: UDI/DI each 10193489253146, UDI/DI case 40193489253147, Lot Number: 23HBI873; Medline Kit Number/SKU DYNJ65185: UDI/DI each 10193489253146, UDI/DI case 40193489253147, Lot Number: 23IBR043; Medline Kit Number/SKU DYNJ65185: UDI/DI each 10193489253146, UDI/DI case 40193489253147, Lot Number: 23KBF277; Medline Kit Number/SKU DYNJ65185: UDI/DI each 10193489253146, UDI/DI case 40193489253147, Lot Number: 24ABQ959; Medline Kit Number/SKU VASC1057: UDI/DI each 10889942431922, UDI/DI case 40889942431923, Lot Number: 25KMF194. |
|---|
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-2143-2026%22
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