FDA Medical devices recall ·
Medline medical convenience kits, containing Namic Manifold… recall
This is an FDA Class I recall — the most serious type.
- Recall number
- Z-2147-2026
- Date
- (initiated March 24, 2026)
- Company / brand
- Medline Industries, LP
3 Lakes Dr, Northfield, IL, United States - Category
- Medical devices › Class I
- Classification
- Class I
- Status
- Ongoing
- Units affected
- 21119 kits
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
Product
Medline medical convenience kits, containing Namic Manifold, Labeled as: 1. MTS,RT,HANDED/LFT,HRT,KIT, Medline Kit Number/SKU 60010508; 2. DBD-MTS,LEFT HEART,KIT, Medline Kit Number/SKU 60160075; 3. CARDIAC CATH PACK, Medline Kit Number/SKU DYNJ04636N; 4. CATH LAB TRAY, Medline Kit Number/SKU DYNJ24250G; 5. CATH LAB PACK-LF, Medline Kit Number/SKU DYNJ38333D; 6. CATH LAB PACK-LF, Medline Kit Number/SKU DYNJ38333F; 7. CATH LAB ANGIOGRAPHY PACK, Medline Kit Number/SKU DYNJ50779G; 8. CATH LAB ANGIOGRAPHY PACK, Medline Kit Number/SKU DYNJ50779I; 9. CLOT RETRIEVAL PACK, Medline Kit Number/SKU DYNJ56140C; 10. TAVR PACK NO SYR, Medline Kit Number/SKU DYNJ62310C; 11. TAVR PACK, Medline Kit Number/SKU DYNJ62310D; 12. TAVR PACK, Medline Kit Number/SKU DYNJ62310F; 13. DIAGNOSTIC 2 PACK, Medline Kit Number/SKU DYNJ81911; 14. DIAGNOSTIC 2 PACK, Medline Kit Number/SKU DYNJ81911A; 15. CATH PACK, Medline Kit Number/SKU DYNJT6544; 16. LHK, Medline Kit Number/SKU NAM0015; 17. SLU LHK, Medline Kit Number/SKU SAMPC0706.
Why was it recalled?
Medline has identified the presence of particulate within the fluid path of the Manifolds.
What should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
Medline Kit Number/SKU 60010508: UDI/DI each 10193489040340, UDI/DI case 40193489040341, Lot Number: 23KBN009; Medline Kit Number/SKU 60010508: UDI/DI each 10193489040340, UDI/DI case 40193489040341, Lot Number: 23LBI829; Medline Kit Number/SKU 60010508: UDI/DI each 10193489040340, UDI/DI case 40193489040341, Lot Number: 24ABH036; Medline Kit Number/SKU 60010508: UDI/DI each 10193489040340, UDI/DI case 40193489040341, Lot Number: 24BBG055; Medline Kit Number/SKU 60010508: UDI/DI each 10193489040340, UDI/DI case 40193489040341, Lot Number: 24EBO156; Medline Kit Number/SKU 60010508: UDI/DI each 10193489040340, UDI/DI case 40193489040341, Lot Number: 24GBS605; Medline Kit Number/SKU 60010508: UDI/DI each 10193489040340, UDI/DI case 40193489040341, Lot Number: 24IBK765; Medline Kit Number/SKU 60010508: UDI/DI each 10193489040340, UDI/DI case 40193489040341, Lot Number: 25ABR102; Medline Kit Number/SKU 60010508: UDI/DI each 10193489040340, UDI/DI case 40193489040341, Lot Number: 25CBK686; Medline Kit Number/SKU 60010508: UDI/DI each 10193489040340, UDI/DI case 40193489040341, Lot Number: 25DBR341; Medline Kit Number/SKU 60010508: UDI/DI each 10193489040340, UDI/DI case 40193489040341, Lot Number: 25EBB568; Medline Kit Number/SKU 60010508: UDI/DI each 10193489040340, UDI/DI case 40193489040341, Lot Number: 25FBB624; Medline Kit Number/SKU 60010508: UDI/DI each 10193489040340, UDI/DI case 40193489040341, Lot Number: 25GBC747; Medline Kit Number/SKU 60010508: UDI/DI each 101934890403
Distribution
US (nationwide) and AE, AU, CA, JP, KR, NL, SG, SK.
States: California
What does Class I mean?
Class I is the most serious FDA recall class: there is a reasonable probability that using or being exposed to the product will cause serious adverse health consequences or death.
Source: FDA (medical devices), recall Z-2147-2026. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.