1. DBD-MTS,3V,MAN,KIT, Medline Kit Number/SKU 60010195; 2. MTS-LEFT HEART,KIT, Medline Kit Number/SKU 60033123; 3. MTS,3 VALVE,KIT, Medline Kit Number/SKU 60050183; 4. MTS,LEFT HEART,KIT, Medline Kit Number/SKU 60080349; 5. MTS,3 VALVE,LEFT HEART,KIT, Medline Kit Number/SKU 60100338; 6. MTS LHK, Medline Kit Number/SKU 60101017; 7. DBD-MTS,3 VALVE,KIT, Medline Kit Number/SKU 60130506; 8. MTS,LEFT,HRT,KIT, Medline Kit Number/SKU 60131324; 9. MTS,LEFT HEART,KIT, Medline Kit Number/SKU 60132238; 10. MTS,3,PORT,KIT, Medline Kit Number/SKU 60138301; 11. MTS,LEFT HEART,KIT, Medline Kit Number/SKU 60140589; 12. MTS,3 VALVE,W/, Medline Kit Number/SKU 60192012; 13. DBD-MTS,4V,MANIFOLD,KIT, Medline Kit Number/SKU 60220488; 14. MTS,LHK, Medline Kit Number/SKU 60232091; 15. MTO,3 VALVE,MANIFOLD,KIT, Medline Kit Number/SKU 65010037; 16. MTO,LEFT HEART,KIT, Medline Kit Number/SKU 65012819; 17. DBD-MTO,2V,LEFT HEART,KIT, Medline Kit Number/SKU 65040421; 18. DBD-MTO,LEFT HEART,KIT, Medline Kit Number/SKU 65183482; 19. MTS KIM, Medline Kit Number/SKU 65660872; 20. LHK,-, Medline Kit Number/SKU 601006269; 21. DBD-MTS,MANIFOLD,KIT, Medline Kit Number/SKU 601203616; 22. MTO,4V,KIT, Medline Kit Number/SKU 650104611; 23. MTO,MANIFOLD,KIT, Medline Kit Number/SKU 651304116; 24. KIMAL 3 PORT RH OFF WITH CC PG, Medline Kit Number/SKU 656206837; 25. KIM MANIFOLD SET VER ONE - PG, Medline Kit Number/SKU 656608724; 26. CARDIAC MAN PG, Medline Kit Number/SKU 656608737; 27. MTO MANIFOLD, Medline Kit Number/SKU 656608739; 28. CARDIAC MANIFOLD SET, Medline Kit Number/SKU 656608749; 29. CARDIAC MAN SET, Medline Kit Number/SKU 656608753; 30. KIMAL 3 PORT MAN KIT, Medline Kit Number/SKU 656608755; 31. DBD-MTS,LHK, Medline Kit Number/SKU 6010236231; 32. LHK, Medline Kit Number/SKU 6561068101; 33. LHK, Medline Kit Number/SKU 60022681B; 34. CARDIAC CATH PACK-LF, Medline Kit Number/SKU DYNJ0376288O; 35. CARDIAC CATH PACK-LF, Medline Kit Nu
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 40193489040235, Lot Number: 24CBF820; Medline Kit Number/SKU 60010195: UDI/DI each 10193489040234, UDI/DI case 40193489040235, Lot Number: 24DBR149; Medline Kit Number/SKU 60010195: UDI/DI each 10193489040234, UDI/DI case 40193489040235, Lot Number: 24HBO437; Medline Kit Number/SKU 60010195: UDI/DI each 10193489040234, UDI/DI case 40193489040235, Lot Number: 24IBJ827; Medline Kit Number/SKU 60010195: UDI/DI each 10193489040234, UDI/DI case 40193489040235, Lot Number: 25ABI082; Medline Kit Number/SKU 60033123: UDI/DI each 10193489042436, UDI/DI case 40193489042437, Lot Number: 25BBI613; Medline Kit Number/SKU 60033123: UDI/DI each 10193489042436, UDI/DI case 40193489042437, Lot Number: 25BBR862; Medline Kit Number/SKU 60033123: UDI/DI each 10193489042436, UDI/DI case 40193489042437, Lot Number: 25DBC934; Medline Kit Number/SKU 60033123: UDI/DI each 10193489042436, UDI/DI case 40193489042437, Lot Number: 25DBT579; Medline Kit Number/SKU 60033123: UDI/DI each 10193489042436, UDI/DI case 40193489042437, Lot Number: 25FBF145; Medline Kit Number/SKU 60033123: UDI/DI each 10193489042436, UDI/DI case 40193489042437, Lot Number: 25GBJ123; Medline Kit Number/SKU 60033123: UDI/DI each 10193489042436, UDI/DI case 40193489042437, Lot Number: 25HBQ032; Medline Kit Number/SKU 60033123: UDI/DI each 10193489042436, UDI/DI case 40193489042437, Lot Number: 25IBF219; Medline Kit Number/SKU 60033123: UDI/DI each 10193489042436, UDI/DI case 40193489042437, Lot Number: 25JBS750; Medline Kit Number/SKU 60033123: UDI/DI each 10193489042436, UDI/DI case 40193489042437, Lot Number: 25LBD357; Medline Kit Number/SKU 60050183: UDI/DI each 10193489043273, UDI/DI case 40193489043274, Lot Number: 25ABW077; Medline Kit Number/SKU 60050183: UDI/DI each 10193489043273, UDI/DI case 40193489043274, Lot Number: 25CBO600; Medline Kit Number/SKU 60050183: UDI/DI each 10193489043273, UDI/DI case 40193489043274, Lot Number: 25DBR987; Medline Kit Number/SKU 60050183: UDI/DI each 10193489043273, UDI/DI case 40193489043274, Lot Number: 25FBH978; Medline Kit Number/SKU 60050183: UDI/DI each 10193489043273, UDI/DI case 40193489043274, Lot Number: 25IBF270; Medline Kit Number/SKU 60050183: UDI/DI each 10193489043273, UDI/DI case 40193489043274, Lot Number: 25KBJ395; Medline Kit Number/SKU 60080349: UDI/DI each 10193489044539, UDI/DI case 40193489044530, Lot Number: 24LBN469; Medline Kit Number/SKU 60080349: UDI/DI each 10193489044539, UDI/DI case 40193489044530, Lot Number: 25CBA408; Medline Kit Number/SKU 60080349: UDI/DI each 10193489044539, UDI/DI case 40193489044530, Lot Number: 25CBK717; Medline Kit Number/SKU 60080349: UDI/DI each 10193489044539, UDI/DI case 40193489044530, Lot Number: 25EBF843; Medline Kit Number/SKU 60080349: UDI/DI each 10193489044539, UDI/DI case 40193489044530, Lot Number: 25IBF307; Medline Kit Number/SKU 60080349: UDI/DI each 10193489044539, UDI/DI case 40193489044530, Lot Number: 25KBA752; Medline Kit Number/SKU 60080349: UDI/DI each 10193489044539, UDI/DI case 40193489044530, Lot Number: 26ABT007; Medline Kit Number/SKU 60100338: UDI/DI each 10193489045062, UDI/DI case 40193489045063, Lot Number: 24LBT840; Medline Kit Number/SKU 60100338: UDI/DI each 10193489045062, UDI/DI case 40193489045063, Lot Number: 25ABU494; Medline Kit Number/SKU 60100338: UDI/DI each 10193489045062, UDI/DI case 40193489045063, Lot Number: 25BBR313; Medline Kit Number/SKU 60100338: UDI/DI each 10193489045062, UDI/DI case 40193489045063, Lot Number: 25DBR517; Medline Kit Number/SKU 60100338: UDI/DI each 10193489045062, UDI/DI case 40193489045063, Lot Number: 25EBB825; Medline Kit Number/SKU 60100338: UDI/DI each 10193489045062, UDI/DI case 40193489045063, Lot Number: 25EBS427; Medline Kit Number/SKU 60100338: UDI/DI each 10193489045062, UDI/DI case 40193489045063, Lot Number: 25FBT465; Medline Kit Number/SKU 60100338: UDI/DI each
- Units affected
- 322460 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-2144-2026
- 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
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