1. DBD-MTS,3V,MAN,KIT, Medline Kit Number/SKU 60010195; 2. MTS-LEFT HEART,KIT, Medline Kit Numb...
FDA Device Recall #Z-2144-2026 - Class I, March 24, 2026
Recall Summary
| Recall Number | Z-2144-2026 |
| Classification | Class I - Serious risk |
| Date Initiated | March 24, 2026 |
| Status | Ongoing |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | Medline Industries, LP |
| Location | Northfield, IL |
| Product Type | Devices |
| Quantity | 322460 kits |
Product Description
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 Number/SKU DYNJ0376288P; 36. CARDIAC CATH PACK, Medline Kit Number/SKU DYNJ04636M; 37. CATH LAB PACK-LF, Medline Kit Number/SKU DYNJ0771922AA; 38. CATH LAB PACK-LF, Medline Kit Number/SKU DYNJ0771922Y; 39. CATH PACK, Medline Kit Number/SKU DYNJ21810L; 40. CATH PACK, Medline Kit Number/SKU DYNJ21810M; 41. CATH PACK, Medline Kit Number/SKU DYNJ21810N; 42. CARDIAC CATH PACK W/ADD ON, Medline Kit Number/SKU DYNJ22553F; 43. CATH LAB TRAY, Medline Kit Number/SKU DYNJ24250F; 44. HEART CATH, Medline Kit Number/SKU DYNJ27274J; 45. HEART CATH, Medline Kit Number/SKU DYNJ27274K; 46. HEART CATH, Medline Kit Number/SKU DYNJ27274L; 47. CARDIAC CATH PACK, Medline Kit Number/SKU DYNJ32376G; 48. CARDIAC CATH PACK, Medline Kit Number/SKU DYNJ32376I; 49. CATH/ANGIO PACK, Medline Kit Number/SKU DYNJ38087G; 50. CATH LAB PACK-LF, Medline Kit Number/SKU DYNJ38333C; 51. CATH PACK, Medline Kit Number/SKU DYNJ44473C; 52. CATH PACK, Medline Kit Number/SKU DYNJ44473D; 53. CATH LAB ANGIOGRAPHY PACK, Medline Kit Number/SKU DYNJ50779F; 54. ANGIO DRAPE CARDIAC PACK, Medline Kit Number/SKU DYNJ51615N; 55. ANGIO DRAPE CARDIAC PACK, Medline Kit Number/SKU DYNJ51615O; 56. ANGIO DRAPE CARDIAC PACK, Medline Kit Number/SKU DYNJ51615Q; 57. CARDIAC CATH IMF 86040- LF, Medline Kit Number/SKU DYNJ53947I; 58. CARDIAC CATH IMF 86040- LF, Medline Kit Number/SKU DYNJ53947J; 59. CARDIAC CATH LAB, Medline Kit Number/SKU DYNJ57748B; 60. PK CUST CATH LAB, Medline Kit Number/SKU DYNJ60584F; 61. PK CUST CATH LAB, Medline Kit Number/SKU DYNJ60584G; 62. PK CUST CATH LAB, Medline Kit Number/SKU DYNJ60584I; 63. HEART ABLATION DRAPE PACK, Medline Kit Number/SKU DYNJ61984B; 64. ANGIOGRAPHY PACK, Medline Kit Number/SKU DYNJ64525B; 65. HMSL ANGIOGRAPHY PACK, Medline Kit Number/SKU DYNJ64525C; 66. CATH LAB PACK, Medline Kit Number/SKU DYNJ64548D; 67. CATH LAB PACK, Medline Kit Number/SKU DYNJ64548F; 68. CATH LAB & E. P. PACK, Medline Kit Number/SKU DYNJ646
Reason for Recall
Medline has identified the presence of particulate within the fluid path of the Manifolds.
Distribution Pattern
US (nationwide) and AE, AU, CA, JP, KR, NL, SG, SK.
Lot / Code Information
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 10193489045062, UDI/DI case 40193489045063, Lot Number: 25IBJ517; Medline Kit Number/SKU 60100338: UDI/DI each 10193489045062, UDI/DI case 40193489045063, Lot Number: 25LBC673; Medline Kit Number/SKU 60100338: UDI/DI each 10193489045062, UDI/DI case 40193489045063, Lot Number: 26BBF073; Medline Kit Number/SKU 60101017: UDI/DI each 10193489045383, UDI/DI case 40193489045384, Lot Number: 23HBX390; Medline Kit Number/SKU 60101017: UDI/DI each 10193489045383, UDI/DI case 40193489045384, Lot Number: 23IBD647; Medline Kit Number/SKU 60101017: UDI/DI each 10193489045383, UDI/DI case 40193489045384, Lot Number: 23LBC207; Medline Kit Number/SKU 60101017: UDI/DI each 10193489045383, UDI/DI case 40193489045384, Lot Number: 24ABK892; Medline Kit Number/SKU 60101017: UDI/DI each 10193489045383, UDI/DI case 40193489045384, Lot Number: 24DBA937; Medline Kit Number/SKU 60101017: UDI/DI each 10193489045383, UDI/DI case 40193489045384, Lot Number: 24DBJ585; Medline Kit Number/SKU 60101017: UDI/DI each 10193489045383, UDI/DI case 40193489045384, Lot Number: 24EBE043; Medline Kit Number/SKU 60101017: UDI/DI each 10193489045383, UDI/DI case 40193489045384, Lot Number: 24IBN995; Medline Kit Number/SKU 60101017: UDI/DI each 10193489045383, UDI/DI case 40193489045384, Lot Number: 24IBO100; Medline Kit Number/SKU 60101017: UDI/DI each 10193489045383, UDI/DI case 40193489045384, Lot Number: 24LBO436; Medline Kit Number/SKU 60101017: UDI/DI each 10193489045383, UDI/DI case 40193489045384, Lot Number: 25CBH999; Medline Kit Number/SKU 60101017: UDI/DI each 10193489045383, UDI/DI case 40193489045384, Lot Number: 25CBT160; Medline Kit Number/SKU 60101017: UDI/DI each 10193489045383, UDI/DI case 40193489045384, Lot Number: 25DBR989; Medline Kit Number/SKU 60101017: UDI/DI each 10193489045383, UDI/DI case 40193489045384, Lot Number: 25FBD599; Medline Kit Number/SKU 60101017: UDI/DI each 10193489045383, UDI/DI case 40193489045384, Lot Number: 25HBN775; Medline Kit Number/SKU 60101017: UDI/DI each 10193489045383, UDI/DI case 40193489045384, Lot Number: 25JBM965; Medline Kit Number/SKU 60101017: UDI/DI each 10193489045383, UDI/DI case 40193489045384, Lot Number: 25LBH604; Medline Kit Number/SKU 60101017: UDI/DI each 10193489045383, UDI/DI case 40193489045384, Lot Number: 25LBS225; Medline Kit Number/SKU 60101017: UDI/DI each 10193489045383, UDI/DI case 40193489045384, Lot Number: 26BBJ154; Medline Kit Number/SKU 60130506: UDI/DI each 10193489046458, UDI/DI case 40193489046459, Lot Number: 23LBD402; Medline Kit Number/SKU 60130506: UDI/DI each 10193489046458, UDI/DI case 40193489046459, Lot Number: 23LBS016; Medline Kit Number/SKU 60130506: UDI/DI each 10193489046458, UDI/DI case 40193489046459, Lot Number: 24ABD855; Medline Kit Number/SKU 60130506: UDI/DI each 10193489046458, UDI/DI case 40193489046459, Lot Number: 24BBG034; Medline Kit Number/SKU 60130506: UDI/DI each 10193489046458, UDI/DI case 40193489046459, Lot Number: 24BBM144; Medline Kit Number/SKU 60130506: UDI/DI each 10193489046458, UDI/DI case 40193489046459, Lot Number: 24CBO038; Medline Kit Number/SKU 60130506: UDI/DI each 10193489046458, UDI/DI case 40193489046459, Lot Number: 24CBO214; Medline Kit Number/SKU 60130506: UDI/DI each 10193489046458, UDI/DI case 40193489046459, Lot Number: 24DBK642; Medline Kit Number/SKU 60130506: UDI/DI each 10193489046458, UDI/DI case 40193489046459, Lot Number: 24KBN940; Medline Kit Number/SKU 60130506: UDI/DI each 10193489046458, UDI/DI case 40193489046459, Lot Number: 25BBS815; Medline Kit Number/SKU 60130506: UDI/DI each 10193489046458, UDI/DI case 40193489046459, Lot Number: 25CBG643; Medline Kit Number/SKU 60130506: UDI/DI each 10193489046458, UDI/DI case 40193489046459, Lot Number: 25CBU110; Medline Kit Number/SKU 60130506: UDI/DI each 10193489046458, UDI/DI case 40193489046459, Lot Number: 25EBC252; Medline Kit Number/SKU 60130506: UDI/DI each 10193489046458, UDI/DI case 40193489046459, Lot Number: 25FBF616; Medline Kit Number/SKU 60130506: UDI/DI each 10193489046458, UDI/DI case 40193489046459, Lot Number: 25FBK959; Medline Kit Number/SKU 60131324: UDI/DI each 10193489046809, UDI/DI case 40193489046800, Lot Number: 24KBN354; Medline Kit Number/SKU 60131324: UDI/DI each 10193489046809, UDI/DI case 40193489046800, Lot Number: 24KBN941; Medline Kit Number/SKU 60131324: UDI/DI each 10193489046809, UDI/DI case 40193489046800, Lot Number: 24LBT120; Medline Kit Number/SKU 60132238: UDI/DI each 10193489047233, UDI/DI case 40193489047234, Lot Number: 24BBR657; Medline Kit Number/SKU 60132238: UDI/DI each 10193489047233, UDI/DI case 40193489047234, Lot Number: 24CBA189; Medline Kit Number/SKU 60132238: UDI/DI each 10193489047233, UDI/DI case 40193489047234, Lot Number: 24FBM887; Medline Kit Number/SKU 60132238: UDI/DI each 10193489047233, UDI/DI case 40193489047234, Lot Number: 25ABG502; Medline Kit Number/SKU 60132238: UDI/DI each 10193489047233, UDI/DI case 40193489047234, Lot Number: 25ABV176; Medline Kit Number/SKU 60132238: UDI/DI each 10193489047233, UDI/DI case 40193489047234, Lot Number: 25BBR314; Medline Kit Number/SKU 60132238: UDI/DI each 10193489047233, UDI/DI case 40193489047234, Lot Number: 25CBI001; Medline Kit Number/SKU 60132238: UDI/DI each 10193489047233, UDI/DI case 40193489047234, Lot Number: 25CBL913; Medline Kit Number/SKU 60132238: UDI/DI each 10193489047233, UDI/DI case 40193489047234, Lot Number: 25CBO416; Medline Kit Number/SKU 60132238: UDI/DI each 10193489047233, UDI/DI case 40193489047234, Lot Number: 25DBV071; Medline Kit Number/SKU 60132238: UDI/DI each 10193489047233, UDI/DI case 40193489047234, Lot Number: 25EBC051; Medline Kit Number/SKU 60132238: UDI/DI each 10193489047233, UDI/DI case 40193489047234, Lot Number: 25EBE549; Medline Kit Number/SKU 60132238: UDI/DI each 10193489047233, UDI/DI case 40193489047234, Lot Number: 25IBT687; Medline Kit Number/SKU 60132238: UDI/DI each 10193489047233, UDI/DI case 40193489047234, Lot Number: 25IBU966; Medline Kit Number/SKU 60132238: UDI/DI each 10193489047233, UDI/DI case 40193489047234, Lot Number: 25KBB948; Medline Kit Number/SKU 60132238: UDI/DI each 10193489047233, UDI/DI case 40193489047234, Lot Number: 26ABM807; Medline Kit Number/SKU 60132238: UDI/DI each 10193489047233, UDI/DI case 40193489047234, Lot Number: 26BBL416; Medline Kit Number/SKU 60132238: UDI/DI each 10193489047233, UDI/DI case 40193489047234, Lot Number: 26CBH011; Medline Kit Number/SKU 60138301: UDI/DI each 10193489047639, UDI/DI case 40193489047630, Lot Number: 25ABF936; Medline Kit Number/SKU 60138301: UDI/DI each 10193489047639, UDI/DI case 40193489047630, Lot Number: 25ABR903; Medline Kit Number/SKU 60138301: UDI/DI each 10193489047639, UDI/DI case 40193489047630, Lot Number: 25BBI319; Medline Kit Number/SKU 60138301: UDI/DI each 10193489047639, UDI/DI case 40193489047630, Lot Number: 25BBQ787; Medline Kit Number/SKU 60138301: UDI/DI each 10193489047639, UDI/DI case 40193489047630, Lot Number: 25DBO069; Medline Kit Number/SKU 60138301: UDI/DI each 10193489047639, UDI/DI case 40193489047630, Lot Number: 25EBP376; Medline Kit Number/SKU 60138301: UDI/DI each 10193489047639, UDI/DI case 40193489047630, Lot Number: 25HBC010; Medline Kit Number/SKU 60138301: UDI/DI each 10193489047639, UDI/DI case 40193489047630, Lot Number: 25JBA192; Medline Kit Number/SKU 60138301: UDI/DI each 10193489047639, UDI/DI case 40193489047630, Lot Number: 25LBA490; Medline Kit Number/SKU 60138301: UDI/DI each 10193489047639, UDI/DI case 40193489047630, Lot Number: 26BBJ144; Medline Kit Number/SKU 60140589: UDI/DI each 10193489048032, UDI/DI case 40193489048033, Lot Number: 24LBQ695; Medline Kit Number/SKU 60140589: UDI/DI each 10193489048032, UDI/DI case 40193489048033, Lot Number: 25ABQ318; Medline Kit Number/SKU 60140589: UDI/DI each 10193489048032, UDI/DI case 40193489048033, Lot Number: 25EBB629; Medline Kit Number/SKU 60140589: UDI/DI each 10193489048032, UDI/DI case 40193489048033, Lot Number: 25FBE410; Medline Kit Number/SKU 60140589: UDI/DI each 10193489048032, UDI/DI case 40193489048033, Lot Number: 25FBO675; Medline Kit Number/SKU 60140589: UDI/DI each 10193489048032, UDI/DI case 40193489048033, Lot Number: 25HBL092; Medline Kit Number/SKU 60140589: UDI/DI each 10193489048032, UDI/DI case 40193489048033, Lot Number: 25IBM684; Medline Kit Number/SKU 60140589: UDI/DI each 10193489048032, UDI/DI case 40193489048033, Lot Number: 25KBJ830; Medline Kit Number/SKU 60140589: UDI/DI each 10193489048032, UDI/DI case 40193489048033, Lot Number: 26ABN648; Medline Kit Number/SKU 60192012: UDI/DI each 10193489050929, UDI/DI case 40193489050920, Lot Number: 24LBL633; Medline Kit Number/SKU 60192012: UDI/DI each 10193489050929, UDI/DI case 40193489050920, Lot Number: 24LBT384; Medline Kit Number/SKU 60192012: UDI/DI each 10193489050929, UDI/DI case 40193489050920, Lot Number: 25CBQ237; Medline Kit Number/SKU 60192012: UDI/DI each 10193489050929, UDI/DI case 40193489050920, Lot Number: 25EBH401; Medline Kit Number/SKU 60192012: UDI/DI each 10193489050929, UDI/DI case 40193489050920, Lot Number: 25GBX825; Medline Kit Number/SKU 60192012: UDI/DI each 10193489050929, UDI/DI case 40193489050920, Lot Number: 25HBL094; Medline Kit Number/SKU 60192012: UDI/DI each 10193489050929, UDI/DI case 40193489050920, Lot Number: 26ABC178; Medline Kit Number/SKU 60192012: UDI/DI each 10193489050929, UDI/DI case 40193489050920, Lot Number: 26ABF962; Medline Kit Number/SKU 60192012: UDI/DI each 10193489050929, UDI/DI case 40193489050920, Lot Number: 26BBN954; Medline Kit Number/SKU 60192012: UDI/DI each 10193489050929, UDI/DI case 40193489050920, Lot Number: 26CBB706; Medline Kit Number/SKU 60220488: UDI/DI each 10193489052527, UDI/DI case 40193489052528, Lot Number: 23LBC519; Medline Kit Number/SKU 60220488: UDI/DI each 10193489052527, UDI/DI case 40193489052528, Lot Number: 23LBC520; Medline Kit Number/SKU 60220488: UDI/DI each 10193489052527, UDI/DI case 40193489052528, Lot Number: 23LBD120; Medline Kit Number/SKU 60220488: UDI/DI each 10193489052527, UDI/DI case 40193489052528, Lot Number: 24BBL703; Medline Kit Number/SKU 60220488: UDI/DI each 10193489052527, UDI/DI case 40193489052528, Lot Number: 24CBM350; Medline Kit Number/SKU 60220488: UDI/DI each 10193489052527, UDI/DI case 40193489052528, Lot Number: 24CBM351; Medline Kit Number/SKU 60220488: UDI/DI each 10193489052527, UDI/DI case 40193489052528, Lot Number: 24HBS750; Medline Kit Number/SKU 60220488: UDI/DI each 10193489052527, UDI/DI case 40193489052528, Lot Number: 24JBC085; Medline Kit Number/SKU 60232091: UDI/DI each 10193489053258, UDI/DI case 40193489053259, Lot Number: 25FBE411; Medline Kit Number/SKU 60232091: UDI/DI each 10193489053258, UDI/DI case 40193489053259, Lot Number: 25GBS552; Medline Kit Number/SKU 60232091: UDI/DI each 10193489053258, UDI/DI case 40193489053259, Lot Number: 25IBN368; Medline Kit Number/SKU 60232091: UDI/DI each 10193489053258, UDI/DI case 40193489053259, Lot Number: 25JBI441; Medline Kit Number/SKU 60232091: UDI/DI each 10193489053258, UDI/DI case 40193489053259, Lot Number: 25JBX630; Medline Kit Number/SKU 60232091: UDI/DI each 10193489053258, UDI/DI case 40193489053259, Lot Number: 25LBC407; Medline Kit Number/SKU 60232091: UDI/DI each 10193489053258, UDI/DI case 40193489053259, Lot Number: 26BBB138; Medline Kit Number/SKU 65010037: UDI/DI each 10193489059502, UDI/DI case 40193489059503, Lot Number: 25CBD801; Medline Kit Number/SKU 65010037: UDI/DI each 10193489059502, UDI/DI case 40193489059503, Lot Number: 25CBK055; Medline Kit Number/SKU 65010037: UDI/DI each 10193489059502, UDI/DI case 40193489059503, Lot Number: 25CBP471; Medline Kit Number/SKU 65010037: UDI/DI each 10193489059502, UDI/DI case 40193489059503, Lot Number: 25DBR961; Medline Kit Number/SKU 65010037: UDI/DI each 10193489059502, UDI/DI case 40193489059503, Lot Number: 25EBD424; Medline Kit Number/SKU 65010037: UDI/DI each 10193489059502, UDI/DI case 40193489059503, Lot Number: 25FBE633; Medline Kit Number/SKU 65010037: UDI/DI each 10193489059502, UDI/DI case 40193489059503, Lot Number: 25FBJ631; Medline Kit Number/SKU 65010037: UDI/DI each 10193489059502, UDI/DI case 40193489059503, Lot Number: 25GBC837; Medline Kit Number/SKU 65010037: UDI/DI each 10193489059502, UDI/DI case 40193489059503, Lot Number: 25GBN114; Medline Kit Number/SKU 65010037: UDI/DI each 10193489059502, UDI/DI case 40193489059503, Lot Number: 25GBW454; Medline Kit Number/SKU 65010037: UDI/DI each 10193489059502, UDI/DI case 40193489059503, Lot Number: 25HBD429; Medline Kit Number/SKU 65010037: UDI/DI each 10193489059502, UDI/DI case 40193489059503, Lot Number: 25IBF794; Medline Kit Number/SKU 65010037: UDI/DI each 10193489059502, UDI/DI case 40193489059503, Lot Number: 25JBL011; Medline Kit Number/SKU 65010037: UDI/DI each 10193489059502, UDI/DI case 40193489059503, Lot Number: 25KBO033; Medline Kit Number/SKU 65010037: UDI/DI each 10193489059502, UDI/DI case 40193489059503, Lot Number: 25KBT052; Medline Kit Number/SKU 65010037: UDI/DI each 10193489059502, UDI/DI case 40193489059503, Lot Number: 25LBC283; Medline Kit Number/SKU 65010037: UDI/DI each 10193489059502, UDI/DI case 40193489059503, Lot Number: 25LBF571; Medline Kit Number/SKU 65012819: UDI/DI each 10193489059687, UDI/DI case 40193489059688, Lot Number: 25CBL361; Medline Kit Number/SKU 65012819: UDI/DI each 10193489059687, UDI/DI case 40193489059688, Lot Number: 25DBQ337; Medline Kit Number/SKU 65012819: UDI/DI each 10193489059687, UDI/DI case 40193489059688, Lot Number: 25EBN624; Medline Kit Number/SKU 65012819: UDI/DI each 10193489059687, UDI/DI case 40193489059688, Lot Number: 25FBE412; Medline Kit Number/SKU 65012819: UDI/DI each 10193489059687, UDI/DI case 40193489059688, Lot Number: 25FBN083; Medline Kit Number/SKU 65012819: UDI/DI each 10193489059687, UDI/DI case 40193489059688, Lot Number: 25GBD061; Medline Kit Number/SKU 65012819: UDI/DI each 10193489059687, UDI/DI case 40193489059688, Lot Number: 25IBG953; Medline Kit Number/SKU 65012819: UDI/DI each 10193489059687, UDI/DI case 40193489059688, Lot Number: 25KBO724; Medline Kit Number/SKU 65012819: UDI/DI each 10193489059687, UDI/DI case 40193489059688, Lot Number: 25KBS323; Medline Kit Number/SKU 65012819: UDI/DI each 10193489059687, UDI/DI case 40193489059688, Lot Number: 26ABC753; Medline Kit Number/SKU 65012819: UDI/DI each 10193489059687, UDI/DI case 40193489059688, Lot Number: 26ABR022; Medline Kit Number/SKU 65040421: UDI/DI each 10193489060416, UDI/DI case 40193489060417, Lot Number: 24KBT591; Medline Kit Number/SKU 65040421: UDI/DI each 10193489060416, UDI/DI case 40193489060417, Lot Number: 24LBE978; Medline Kit Number/SKU 65040421: UDI/DI each 10193489060416, UDI/DI case 40193489060417, Lot Number: 25DBQ343; Medline Kit Number/SKU 65040421: UDI/DI each 10193489060416, UDI/DI case 40193489060417, Lot Number: 25DBT925; Medline Kit Number/SKU 65040421: UDI/DI each 10193489060416, UDI/DI case 40193489060417, Lot Number: 25EBJ331; Medline Kit Number/SKU 65040421: UDI/DI each 10193489060416, UDI/DI case 40193489060417, Lot Number: 25EBN550; Medline Kit Number/SKU 65040421: UDI/DI each 10193489060416, UDI/DI case 40193489060417, Lot Number: 25EBU247; Medline Kit Number/SKU 65040421: UDI/DI each 10193489060416, UDI/DI case 40193489060417, Lot Number: 25FBE413; Medline Kit Number/SKU 65040421: UDI/DI each 10193489060416, UDI/DI case 40193489060417, Lot Number: 25FBF761; Medline Kit Number/SKU 65040421: UDI/DI each 10193489060416, UDI/DI case 40193489060417, Lot Number: 25HBA587; Medline Kit Number/SKU 65040421: UDI/DI each 10193489060416, UDI/DI case 40193489060417, Lot Number: 25JBL132; Medline Kit Number/SKU 65040421: UDI/DI each 10193489060416, UDI/DI case 40193489060417, Lot Number: 25JBR927; Medline Kit Number/SKU 65183482: UDI/DI each 10193489062823, UDI/DI case 40193489062824, Lot Number: 23LBV434; Medline Kit Number/SKU 65183482: UDI/DI each 10193489062823, UDI/DI case 40193489062824, Lot Number: 24CBB755; Medline Kit Number/SKU 65660872: UDI/DI each 10193489989557, UDI/DI case 40193489989558, Lot Number: 23KBJ803; Medline Kit Number/SKU 65660872: UDI/DI each 10193489989557, UDI/DI case 40193489989558, Lot Number: 23LBC925; Medline Kit Number/SKU 65660872: UDI/DI each 10193489989557, UDI/DI case 40193489989558, Lot Number: 23LBP705; Medline Kit Number/SKU 65660872: UDI/DI each 10193489989557, UDI/DI case 40193489989558, Lot Number: 24BBK267; Medline Kit Number/SKU 65660872: UDI/DI each 10193489989557, UDI/DI case 40193489989558, Lot Number: 24DBU989; Medline Kit Number/SKU 65660872: UDI/DI each 10193489989557, UDI/DI case 40193489989558, Lot Number: 24GBT179; Medline Kit Number/SKU 65660872: UDI/DI each 10193489989557, UDI/DI case 40193489989558, Lot Number: 24IBL496; Medline Kit Number/SKU 65660872: UDI/DI each 10193489989557, UDI/DI case 40193489989558, Lot Number: 24JBA690; Medline Kit Number/SKU 65660872: UDI/DI each 10193489989557, UDI/DI case 40193489989558, Lot Number: 24KBI563; Medline Kit Number/SKU 65660872: UDI/DI each 10193489989557, UDI/DI case 40193489989558, Lot Number: 24KBN943; Medline Kit Number/SKU 65660872: UDI/DI each 10193489989557, UDI/DI case 40193489989558, Lot Number: 24KBQ269; Medline Kit Number/SKU 65660872: UDI/DI each 10193489989557, UDI/DI case 40193489989558, Lot Number: 24LBJ407; Medline Kit Number/SKU 65660872: UDI/DI each 10193489989557, UDI/DI case 40193489989558, Lot Number: 24LBO500; Medline Kit Number/SKU 65660872: UDI/DI each 10193489989557, UDI/DI case 40193489989558, Lot Number: 25ABB054; Medline Kit Number/SKU 65660872: UDI/DI each 10193489989557, UDI/DI case 40193489989558, Lot Number: 25BBI520; Medline Kit Number/SKU 65660872: UDI/DI each 10193489989557, UDI/DI case 40193489989558, Lot Number: 25CBL739; Medline Kit Number/SKU 65660872: UDI/DI each 10193489989557, UDI/DI case 40193489989558, Lot Number: 25CBT917; Medline Kit Number/SKU 65660872: UDI/DI each 10193489989557, UDI/DI case 40193489989558, Lot Number: 25DBA597; Medline Kit Number/SKU 65660872: UDI/DI each 10193489989557, UDI/DI case 40193489989558, Lot Number: 25FBQ181; Medline Kit Number/SKU 65660872: UDI/DI each 10193489989557, UDI/DI case 40193489989558, Lot Number: 25FBS611; Medline Kit Number/SKU 65660872: UDI/DI each 10193489989557, UDI/DI case 40193489989558, Lot Number: 25HBL493; Medline Kit Number/SKU 65660872: UDI/DI each 10193489989557, UDI/DI case 40193489989558, Lot Number: 25IBI773; Medline Kit Number/SKU 65660872: UDI/DI each 10193489989557, UDI/DI case 40193489989558, Lot Number: 25IBT228; Medline Kit Number/SKU 65660872: UDI/DI each 10193489989557, UDI/DI case 40193489989558, Lot Number: 25LBI277; Medline Kit Number/SKU 601006269: UDI/DI each 10193489189582, UDI/DI case 40193489189583, Lot Number: 23KBW790; Medline Kit Number/SKU 601006269: UDI/DI each 10193489189582, UDI/DI case 40193489189583, Lot Number: 24BBG011; Medline Kit Number/SKU 601006269: UDI/DI each 10193489189582, UDI/DI case 40193489189583, Lot Number: 24BBV062; Medline Kit Number/SKU 601006269: UDI/DI each 10193489189582, UDI/DI case 40193489189583, Lot Number: 24EBH524; Medline Kit Number/SKU 601006269: UDI/DI each 10193489189582, UDI/DI case 40193489189583, Lot Number: 24FBD353; Medline Kit Number/SKU 601006269: UDI/DI each 10193489189582, UDI/DI case 40193489189583, Lot Number: 24GBT409; Medline Kit Number/SKU 601006269: UDI/DI each 10193489189582, UDI/DI case 40193489189583, Lot Number: 24GBT418; Medline Kit Number/SKU 601006269: UDI/DI each 10193489189582, UDI/DI case 40193489189583, Lot Number: 24JBX239; Medline Kit Number/SKU 601006269: UDI/DI each 10193489189582, UDI/DI case 40193489189583, Lot Number: 24KBL357; Medline Kit Number/SKU 601006269: UDI/DI each 10193489189582, UDI/DI case 40193489189583, Lot Number: 24KBL665; Medline Kit Number/SKU 601006269: UDI/DI each 10193489189582, UDI/DI case 40193489189583, Lot Number: 24KBR053; Medline Kit Number/SKU 601006269: UDI/DI each 10193489189582, UDI/DI case 40193489189583, Lot Number: 24LBB805; Medline Kit Number/SKU 601006269: UDI/DI each 10193489189582, UDI/DI case 40193489189583, Lot Number: 25CBN927; Medline Kit Number/SKU 601006269: UDI/DI each 10193489189582, UDI/DI case 40193489189583, Lot Number: 25EBA296; Medline Kit Number/SKU 601006269: UDI/DI each 10193489189582, UDI/DI case 40193489189583, Lot Number: 25FBN589; Medline Kit Number/SKU 601006269: UDI/DI each 10193489189582, UDI/DI case 40193489189583, Lot Number: 25IBF118; Medline Kit Number/SKU 601006269: UDI/DI each 10193489189582, UDI/DI case 40193489189583, Lot Number: 25IBV472; Medline Kit Number/SKU 601006269: UDI/DI each 10193489189582, UDI/DI case 40193489189583, Lot Number: 26ABA296; Medline Kit Number/SKU 601006269: UDI/DI each 10193489189582, UDI/DI case 40193489189583, Lot Number: 26ABM374; Medline Kit Number/SKU 601006269: UDI/DI each 10193489189582, UDI/DI case 40193489189583, Lot Number: 26BBO252; Medline Kit Number/SKU 601203616: UDI/DI each 10193489070774, UDI/DI case 40193489070775, Lot Number: 23LBN507; Medline Kit Number/SKU 601203616: UDI/DI each 10193489070774, UDI/DI case 40193489070775, Lot Number: 24BBD883; Medline Kit Number/SKU 601203616: UDI/DI each 10193489070774, UDI/DI case 40193489070775, Lot Number: 24CBP951; Medline Kit Number/SKU 601203616: UDI/DI each 10193489070774, UDI/DI case 40193489070775, Lot Number: 24FBS128; Medline Kit Number/SKU 601203616: UDI/DI each 10193489070774, UDI/DI case 40193489070775, Lot Number: 24HBL889; Medline Kit Number/SKU 601203616: UDI/DI each 10193489070774, UDI/DI case 40193489070775, Lot Number: 24HBW911; Medline Kit Number/SKU 650104611: UDI/DI each 10193489074802, UDI/DI case 40193489074803, Lot Number: 24LBO506; Medline Kit Number/SKU 650104611: UDI/DI each 10193489074802, UDI/DI case 40193489074803, Lot Number: 25ABL641; Medline Kit Number/SKU 650104611: UDI/DI each 10193489074802, UDI/DI case 40193489074803, Lot Number: 25BBM277; Medline Kit Number/SKU 650104611: UDI/DI each 10193489074802, UDI/DI case 40193489074803, Lot Number: 25CBL017; Medline Kit Number/SKU 650104611: UDI/DI each 10193489074802, UDI/DI case 40193489074803, Lot Number: 25CBN644; Medline Kit Number/SKU 650104611: UDI/DI each 10193489074802, UDI/DI case 40193489074803, Lot Number: 25CBS021; Medline Kit Number/SKU 650104611: UDI/DI each 10193489074802, UDI/DI case 40193489074803, Lot Number: 25EBG284; Medline Kit Number/SKU 650104611: UDI/DI each 10193489074802, UDI/DI case 40193489074803, Lot Number: 25FBI559; Medline Kit Number/SKU 650104611: UDI/DI each 10193489074802, UDI/DI case 40193489074803, Lot Number: 25GBC062; Medline Kit Number/SKU 650104611: UDI/DI each 10193489074802, UDI/DI case 40193489074803, Lot Number: 25GBN092; Medline Kit Number/SKU 650104611: UDI/DI each 10193489074802, UDI/DI case 40193489074803, Lot Number: 25HBG211; Medline Kit Number/SKU 650104611: UDI/DI each 10193489074802, UDI/DI case 40193489074803, Lot Number: 25IBA166; Medline Kit Number/SKU 650104611: UDI/DI each 10193489074802, UDI/DI case 40193489074803, Lot Number: 25IBR553; Medline Kit Number/SKU 650104611: UDI/DI each 10193489074802, UDI/DI case 40193489074803, Lot Number: 25JBA722; Medline Kit Number/SKU 650104611: UDI/DI each 10193489074802, UDI/DI case 40193489074803, Lot Number: 25JBJ009; Medline Kit Number/SKU 650104611: UDI/DI each 10193489074802, UDI/DI case 40193489074803, Lot Number: 25JBL024; Medline Kit Number/SKU 650104611: UDI/DI each 10193489074802, UDI/DI case 40193489074803, Lot Number: 25JBX186; Medline Kit Number/SKU 650104611: UDI/DI each 10193489074802, UDI/DI case 40193489074803, Lot Number: 25KBH488; Medline Kit Number/SKU 650104611: UDI/DI each 10193489074802, UDI/DI case 40193489074803, Lot Number: 25LBM779; Medline Kit Number/SKU 650104611: UDI/DI each 10193489074802, UDI/DI case 40193489074803, Lot Number: 25LBM780; Medline Kit Number/SKU 650104611: UDI/DI each 10193489074802, UDI/DI case 40193489074803, Lot Number: 26ABG265; Medline Kit Number/SKU 650104611: UDI/DI each 10193489074802, UDI/DI case 40193489074803, Lot Number: 26ABR490; Medline Kit Number/SKU 650104611: UDI/DI each 10193489074802, UDI/DI case 40193489074803, Lot Number: 26ABR491; Medline Kit Number/SKU 650104611: UDI/DI each 10193489074802, UDI/DI case 40193489074803, Lot Number: 26ABR492; Medline Kit Number/SKU 650104611: UDI/DI each 10193489074802, UDI/DI case 40193489074803, Lot Number: 26ABU629; Medline Kit Number/SKU 650104611: UDI/DI each 10193489074802, UDI/DI case 40193489074803, Lot Number: 26BBF384; Medline Kit Number/SKU 650104611: UDI/DI each 10193489074802, UDI/DI case 40193489074803, Lot Number: 26BBI348; Medline Kit Number/SKU 650104611: UDI/DI each 10193489074802, UDI/DI case 40193489074803, Lot Number: 26BBL421; Medline Kit Number/SKU 650104611: UDI/DI each 10193489074802, UDI/DI case 40193489074803, Lot Number: 26BBT130; Medline Kit Number/SKU 650104611: UDI/DI each 10193489074802, UDI/DI case 40193489074803, Lot Number: 26CBA497; Medline Kit Number/SKU 651304116: UDI/DI each 10193489075892, UDI/DI case 40193489075893, Lot Number: 25BBD354; Medline Kit Number/SKU 651304116: UDI/DI each 10193489075892, UDI/DI case 40193489075893, Lot Number: 25BBI530; Medline Kit Number/SKU 651304116: UDI/DI each 10193489075892, UDI/DI case 40193489075893, Lot Number: 25CBD811; Medline Kit Number/SKU 651304116: UDI/DI each 10193489075892, UDI/DI case 40193489075893, Lot Number: 25CBL374; Medline Kit Number/SKU 651304116: UDI/DI each 10193489075892, UDI/DI case 40193489075893, Lot Number: 25DBQ359; Medline Kit Number/SKU 651304116: UDI/DI each 10193489075892, UDI/DI case 40193489075893, Lot Number: 25EBJ265; Medline Kit Number/SKU 651304116: UDI/DI each 10193489075892, UDI/DI case 40193489075893, Lot Number: 25EBU808; Medline Kit Number/SKU 651304116: UDI/DI each 10193489075892, UDI/DI case 40193489075893, Lot Number: 25EBV383; Medline Kit Number/SKU 651304116: UDI/DI each 10193489075892, UDI/DI case 40193489075893, Lot Number: 25GBG209; Medline Kit Number/SKU 651304116: UDI/DI each 10193489075892, UDI/DI case 40193489075893, Lot Number: 25GBH353; Medline Kit Number/SKU 651304116: UDI/DI each 10193489075892, UDI/DI case 40193489075893, Lot Number: 25GBN115; Medline Kit Number/SKU 651304116: UDI/DI each 10193489075892, UDI/DI case 40193489075893, Lot Number: 25GBV470; Medline Kit Number/SKU 651304116: UDI/DI each 10193489075892, UDI/DI case 40193489075893, Lot Number: 25GBW455; Medline Kit Number/SKU 651304116: UDI/DI each 10193489075892, UDI/DI case 40193489075893, Lot Number: 25GBX436; Medline Kit Number/SKU 651304116: UDI/DI each 10193489075892, UDI/DI case 40193489075893, Lot Number: 25JBU837; Medline Kit Number/SKU 651304116: UDI/DI each 10193489075892, UDI/DI case 40193489075893, Lot Number: 25KBR043; Medline Kit Number/SKU 651304116: UDI/DI each 10193489075892, UDI/DI case 40193489075893, Lot Number: 25LBT349; Medline Kit Number/SKU 651304116: UDI/DI each 10193489075892, UDI/DI case 40193489075893, Lot Number: 26ABE723; Medline Kit Number/SKU 656206837: UDI/DI each 10193489991376, UDI/DI case 40193489991377, Lot Number: 23JBN268; Medline Kit Number/SKU 656206837: UDI/DI each 10193489991376, UDI/DI case 40193489991377, Lot Number: 23KBJ916; Medline Kit Number/SKU 656206837: UDI/DI each 10193489991376, UDI/DI case 40193489991377, Lot Number: 23LBC919; Medline Kit Number/SKU 656206837: UDI/DI each 10193489991376, UDI/DI case 40193489991377, Lot Number: 23LBI119; Medline Kit Number/SKU 656206837: UDI/DI each 10193489991376, UDI/DI case 40193489991377, Lot Number: 24ABI603; Medline Kit Number/SKU 656206837: UDI/DI each 10193489991376, UDI/DI case 40193489991377, Lot Number: 24BBI553; Medline Kit Number/SKU 656206837: UDI/DI each 10193489991376, UDI/DI case 40193489991377, Lot Number: 24DBK464; Medline Kit Number/SKU 656206837: UDI/DI each 10193489991376, UDI/DI case 40193489991377, Lot Number: 24GBT178; Medline Kit Number/SKU 656206837: UDI/DI each 10193489991376, UDI/DI case 40193489991377, Lot Number: 24HBI912; Medline Kit Number/SKU 656206837: UDI/DI each 10193489991376, UDI/DI case 40193489991377, Lot Number: 24IBA808; Medline Kit Number/SKU 656206837: UDI/DI each 10193489991376, UDI/DI case 4019348999
Other Recalls from Medline Industries, LP
| Recall # | Classification | Product | Date |
|---|---|---|---|
| Z-2790-2026 | Class II | Medline medical convenience kits labeled as: ... | Jun 11, 2026 |
| Z-2788-2026 | Class II | Medline medical convenience kits labeled as: ... | Jun 11, 2026 |
| Z-2791-2026 | Class II | Medline medical convenience kits labeled as: ... | Jun 11, 2026 |
| Z-2789-2026 | Class II | Medline medical convenience kits labeled as: ... | Jun 11, 2026 |
| Z-2737-2026 | Class II | Medline Kits containing Zimmer Biomet mixing bo... | Jun 10, 2026 |
Frequently Asked Questions
Contact your healthcare provider and the device manufacturer immediately. Check whether your specific model number and lot number are included in the recall scope. For external devices, stop using the affected product and arrange a replacement. For implanted devices, do not panic, removal is typically not required unless the risk assessment clearly indicates it. Your physician will guide you based on your individual clinical situation and the FDA's recommended actions. Report any adverse effects you may have experienced to FDA MedWatch at 1-800-FDA-1088.
Class I recalls indicate a reasonable probability of serious adverse health consequences or death from the defect. Class II recalls involve products that may cause temporary or medically reversible adverse health consequences, or where serious consequences are remote. Class III recalls cover products not likely to cause any adverse health consequences, typically involving technical regulatory violations. The classification guides urgency, Class I recalls require immediate action, while Class III may simply involve returning a product or acknowledging a labeling change. Always read the specific recall notice for recommended patient actions.
Report problems with medical devices to the FDA through MedWatch at 1-800-FDA-1088 or online at FDA.gov/safety/medwatch. Healthcare facilities are required by law to report device-related serious injuries and deaths. Patients and consumers can also report voluntarily. Include the device name, manufacturer, model number, and a description of the problem and any patient outcome. Reports from patients and clinicians help the FDA identify emerging safety signals and may trigger investigations that lead to recalls of dangerous devices.
What Should You Do?
Stop using this device if you are affected by this recall. Contact your healthcare provider and the manufacturer immediately for guidance. Report adverse events to FDA MedWatch.