1. 3 VALVE MAN KIT, Medline Kit SKU Number: 65101544; 2. 3V MANIFOLD KIT, Medline Kit SKU Number: 65110351; 3. HEART CATH PACK-LF, Medline Kit SKU Number: DYNJ0373285M; 4. ANGIO DRAPE CARDIAC PACK, Medline Kit SKU Number: DYNJ51615P; 5. ANGIO DRAPE CARDIAC PACK, Medline Kit SKU Number: DYNJ51615R; 6. HEART RADIAL LAB PACK, Medline Kit SKU Number: DYNJ61982C; 7. HEART RADIAL LAB PACK, Medline Kit SKU Number: DYNJ61982D; 8. HEART ABLATION DRAPE PACK, Medline Kit SKU Number: DYNJ61984C; 9. TAVR PACK, Medline Kit SKU Number: DYNJ62310B; 10. HEART TAVR PACK, Medline Kit SKU Number: DYNJ65174G; 11. FEMORAL CARDIAC CATH, Medline Kit SKU Number: DYNJ66343A; 12. CARDIAC CATH PACK, Medline Kit SKU Number: DYNJ66693C; 13. TAVR PACK, Medline Kit SKU Number: DYNJ67225C; 14. AFIB TRAY, Medline Kit SKU Number: DYNJ85069; 15. AFIB TRAY, Medline Kit SKU Number: DYNJ85069A; 16. AFIB TRAY, Medline Kit SKU Number: DYNJ85069B; 17. MTO,LEFT HEART,KIT, Medline Kit SKU Number: VASC1811. Namic medical convenience kits, containing Namic Manifold, Labeled as: 1. DBD-MTS,3V,MAN,KIT, Medline Kit Number/SKU 60010195; 2. MTS,4 VALVE,LFT,HRT,KIT, Medline Kit Number/SKU 60010468; 3. MTO,ADD,ON,KIT, Medline Kit Number/SKU 60010469; 4. MTS,RT,HANDED/LFT,HRT,KIT, Medline Kit Number/SKU 60010508; 5. MTS,LFT,HRT,KIT, Medline Kit Number/SKU 60012911; 6. MTO,RIGHT HEART,KIT, Medline Kit Number/SKU 60012912; 7. DBD-MTS,LEFT HEART,KIT, Medline Kit Number/SKU 60013001; 8. MTS,LEFT HEART,KIT, Medline Kit Number/SKU 60013101; 9. MTS,LFT,HRT,W/WIRE, Medline Kit Number/SKU 60013112; 10. MTS,-,3V,KIT, Medline Kit Number/SKU 60020608; 11. MTO,ANGIO,KIT, Medline Kit Number/SKU 60032681; 12. MTS-LEFT HEART,KIT, Medline Kit Number/SKU 60033123; 13. MTS,RIGHT HEART,KIT, Medline Kit Number/SKU 60033124; 14. MTO,LEFT HEART,KIT, Medline Kit Number/SKU 60034644; 15. MTS,LEFT HEART,KIT, Medline Kit Number/SKU 60040273; 16. MTO,2V,LEFT
Class I
- Recalling firm
- Medline Industries, LP
- Reason for recall
- Medline has identified the presence of particulate within the fluid path of the Manifolds.
- Affected products (lot / model / serial)
- Medline Kit Number/SKU 60010195: UDI/DI each 10193489040234, UDI/DI case 30193489040238, Lot Number: 91637; Medline Kit Number/SKU 60010195: UDI/DI each 10193489040234, UDI/DI case 30193489040238, Lot Number: 91667; Medline Kit Number/SKU 60010195: UDI/DI each 10193489040234, UDI/DI case 30193489040238, Lot Number: 92995; Medline Kit Number/SKU 60010195: UDI/DI each 10193489040234, UDI/DI case 30193489040238, Lot Number: 95615; Medline Kit Number/SKU 60010195: UDI/DI each 10193489040234, UDI/DI case 30193489040238, Lot Number: 97091; Medline Kit Number/SKU 60010195: UDI/DI each 10193489040234, UDI/DI case 30193489040238, Lot Number: 102177; Medline Kit Number/SKU 60010195: UDI/DI each 10193489040234, UDI/DI case 30193489040238, Lot Number: 104282; Medline Kit Number/SKU 60010195: UDI/DI each 10193489040234, UDI/DI case 30193489040238, Lot Number: 108922; Medline Kit Number/SKU 60010195: UDI/DI each 10193489040234, UDI/DI case 30193489040238, Lot Number: 110250; Medline Kit Number/SKU 60010468: UDI/DI each 10193489040319, UDI/DI case 30193489040313, Lot Number: 89290; Medline Kit Number/SKU 60010468: UDI/DI each 10193489040319, UDI/DI case 30193489040313, Lot Number: 91926; Medline Kit Number/SKU 60010468: UDI/DI each 10193489040319, UDI/DI case 30193489040313, Lot Number: 98742; Medline Kit Number/SKU 60010468: UDI/DI each 10193489040319, UDI/DI case 30193489040313, Lot Number: 100867; Medline Kit Number/SKU 60010468: UDI/DI each 10193489040319, UDI/DI case 30193489040313, Lot Number: 103336; Medline Kit Number/SKU 60010468: UDI/DI each 10193489040319, UDI/DI case 30193489040313, Lot Number: 112524; Medline Kit Number/SKU 60010468: UDI/DI each 10193489040319, UDI/DI case 30193489040313, Lot Number: 120251; Medline Kit Number/SKU 60010468: UDI/DI each 10193489040319, UDI/DI case 30193489040313, Lot Number: 123676; Medline Kit Number/SKU 60010468: UDI/DI each 10193489040319, UDI/DI case 30193489040313, Lot Number: 126203; Medline Kit Number/SKU 60010468: UDI/DI each 10193489040319, UDI/DI case 30193489040313, Lot Number: 133960; Medline Kit Number/SKU 60010468: UDI/DI each 10193489040319, UDI/DI case 30193489040313, Lot Number: 135744; Medline Kit Number/SKU 60010468: UDI/DI each 10193489040319, UDI/DI case 30193489040313, Lot Number: 140099; Medline Kit Number/SKU 60010468: UDI/DI each 10193489040319, UDI/DI case 30193489040313, Lot Number: 142801; Medline Kit Number/SKU 60010468: UDI/DI each 10193489040319, UDI/DI case 30193489040313, Lot Number: 144713; Medline Kit Number/SKU 60010468: UDI/DI each 10193489040319, UDI/DI case 30193489040313, Lot Number: 146930; Medline Kit Number/SKU 60010468: UDI/DI each 10193489040319, UDI/DI case 30193489040313, Lot Number: 149252; Medline Kit Number/SKU 60010468: UDI/DI each 10193489040319, UDI/DI case 30193489040313, Lot Number: 152505; Medline Kit Number/SKU 60010468: UDI/DI each 10193489040319, UDI/DI case 30193489040313, Lot Number: 155032; Medline Kit Number/SKU 60010468: UDI/DI each 10193489040319, UDI/DI case 30193489040313, Lot Number: 159209; Medline Kit Number/SKU 60010468: UDI/DI each 10193489040319, UDI/DI case 30193489040313, Lot Number: 163547; Medline Kit Number/SKU 60010468: UDI/DI each 10193489040319, UDI/DI case 30193489040313, Lot Number: 168371; Medline Kit Number/SKU 60010468: UDI/DI each 10193489040319, UDI/DI case 30193489040313, Lot Number: 173236; Medline Kit Number/SKU 60010468: UDI/DI each 10193489040319, UDI/DI case 30193489040313, Lot Number: 173695; Medline Kit Number/SKU 60010468: UDI/DI each 10193489040319, UDI/DI case 30193489040313, Lot Number: 177889; Medline Kit Number/SKU 60010468: UDI/DI each 10193489040319, UDI/DI case 30193489040313, Lot Number: 180765; Medline Kit Number/SKU 60010468: UDI/DI each 10193489040319, UDI/DI case 30193489040313, Lot Number: 185246; Medline Kit Number/SKU 60010469: UDI/DI each 10193489040326, UDI/DI case 30193489040320, Lot Number: 103509; Medline Kit
- Units affected
- 567675 kits
- Distribution pattern
- US (nationwide) and AE, AU, CA, JP, KR, NL, SG, SK.
- Firm location
- Northfield, IL, United States
- Recall type
- Voluntary: Firm initiated
- How the firm notified customers
- Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
- Product type
- Devices
- Status
- Ongoing
- Recall number
- Z-2145-2026
- Recall initiated
- March 24, 2026
- FDA classification date
- May 8, 2026
- FDA report date
- May 20, 2026
- FDA event ID
- 98735
- Last updated on HTM Vibe
- July 24, 2026
View on openFDA