Medline Industries, LP recalls 1. 3 VALVE MAN KIT

Recalling company

Medline Industries, LP

Product

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 HEART,KIT, Medline Kit Number/SKU 60040424; 17. MTS,3,VAVLE,KIT, Medline Kit Number/SKU 60041082; 18. MTS,2V,KIT, Medline Kit Number/SKU 60042453; 19. MTO,3V,KIT, Medline Kit Number/SKU 60042454; 20. MTS,LEFT HEART,KIT, Medline Kit Number/SKU 60042721; 21. MTS,3 VALVE,KIT, Medline Kit Number/SKU 60050183; 22. MTS,3 VALVE,MANIFOLD,KIT, Medline Kit Number/SKU 60060268; 23. MTO,RT,HRT,KIT, Medline Kit Number/SKU 60060564; 24. MTO,LEFT HEART,KIT, Medline Kit Number/SKU 60060569; 25. MTS, Medline Kit Number/SKU 60062021; 26. MTS,LEFT HEART,KIT, Medline Kit Number/SKU 60071232; 27. MTO,CATH,LAB,KIT, Medline Kit Number/SKU 60080221; 28. MTO,RIGHT, Medline Kit Number/SKU 60080347; 29. MTS,LEFT HEART,KIT, Medline Kit Number/SKU 60080349; 30. MTS,MANIFOLD,KIT, Medline Kit Number/SKU 60080716; 31. MTS,LEFT,HRT,KIT, Medline Kit Number/SKU 60081001; 32. MTS,RIGHT HEART,KIT, Medline Kit Number/SKU 60081002; 33. MTO,LEFT,HRT(RT,HANDED), Medline Kit Number/SKU 60081168; 34. MTO,RIGHT HEART,KIT, Medline Kit Number/SKU 60090123; 35. MTS,LEFT HEART,KIT, Medline Kit Number/SKU 60091111; 36. MTS,EP,KIT, Medline Kit Number/SKU 60100056; 37. MTS,3 VALVE,LEFT HEART,KIT, Medline Kit Number/SKU 60100338; 38. MTO,RIGHT HEART,KIT, Medline Kit Number/SKU 60100339; 39. DBD-MTO,LEFT HEART,KIT, Medline Kit Number/SKU 60110273; 40. MTO,RIGHT HEART,KIT, Medline Kit Number/SKU 60110701; 41. MTS,3 VALVE,KIT, Medline Kit Number/SKU 60120693; 42. MTS,LEFT HEART,KIT, Medline Kit Number/SKU 60121817; 43. MTO,CATH,KIT, Medline Kit Number/SKU 60130124; 44. MTO,LEFT HEART,KIT, Medline Kit Number/SKU 60130318; 45. DBD-MTS,3 VALVE,KIT, Medline Kit Number/SKU 60130506; 46. MTO,RT HEART,KIT, Medline Kit Number/SKU 60131323; 47. MTS,LEFT,HRT,KIT, Medline Kit Number/SKU 60131324; 48. DBD-MTS,LEFT HEART,KIT, Medline Kit Number/SKU 60131554; 49. MTS,LEFT HEART,KIT, Medline Kit Number/SKU 60131815; 50. MTO,RT,HRT,KIT, Medline Kit Number/SKU 60

Reason

Medline has identified the presence of particulate within the fluid path of the Manifolds.

Classification

Class I – a reasonable probability that use will cause serious adverse health consequences or death

Recall date

Mar 24, 2026

Reported

May 20, 2026

Distribution

US (nationwide) and AE, AU, CA, JP, KR, NL, SG, SK.

Status

Ongoing

Quantity

567675 kits

Lot / codes

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

Company location

Northfield, IL

Recall type

Voluntary: Firm initiated

Recall number

Z-2145-2026

Agency

U.S. Food and Drug Administration (FDA)

View official FDA notice ↗ Search recall number Z-2145-2026 in the FDA Enforcement Report. Also see FDA recall press releases.