1. 3 VALVE MAN KIT, Medline Kit SKU Number: 65101544; 2. 3V MANIFOLD KIT, Medline Kit SKU Numb...
FDA Device Recall #Z-2145-2026 - Class I, March 24, 2026
Recall Summary
| Recall Number | Z-2145-2026 |
| 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 | 567675 kits |
Product Description
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 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 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 Number/SKU 60010469: UDI/DI each 10193489040326, UDI/DI case 30193489040320, Lot Number: 105131; Medline Kit Number/SKU 60010469: UDI/DI each 10193489040326, UDI/DI case 30193489040320, Lot Number: 141748; Medline Kit Number/SKU 60010469: UDI/DI each 10193489040326, UDI/DI case 30193489040320, Lot Number: 146031; Medline Kit Number/SKU 60010469: UDI/DI each 10193489040326, UDI/DI case 30193489040320, Lot Number: 172932; Medline Kit Number/SKU 60010469: UDI/DI each 10193489040326, UDI/DI case 30193489040320, Lot Number: 180179; Medline Kit Number/SKU 60010469: UDI/DI each 10193489040326, UDI/DI case 30193489040320, Lot Number: 180226; Medline Kit Number/SKU 60010469: UDI/DI each 10193489040326, UDI/DI case 30193489040320, Lot Number: 185514; Medline Kit Number/SKU 60010508: UDI/DI each 10193489040340, UDI/DI case 30193489040344, Lot Number: 101553; Medline Kit Number/SKU 60010508: UDI/DI each 10193489040340, UDI/DI case 30193489040344, Lot Number: 103798; Medline Kit Number/SKU 60010508: UDI/DI each 10193489040340, UDI/DI case 30193489040344, Lot Number: 122264; Medline Kit Number/SKU 60012911: UDI/DI each 10193489040685, UDI/DI case 30193489040689, Lot Number: 91220; Medline Kit Number/SKU 60012911: UDI/DI each 10193489040685, UDI/DI case 30193489040689, Lot Number: 91833; Medline Kit Number/SKU 60012911: UDI/DI each 10193489040685, UDI/DI case 30193489040689, Lot Number: 95789; Medline Kit Number/SKU 60012911: UDI/DI each 10193489040685, UDI/DI case 30193489040689, Lot Number: 97737; Medline Kit Number/SKU 60012911: UDI/DI each 10193489040685, UDI/DI case 30193489040689, Lot Number: 104805; Medline Kit Number/SKU 60012911: UDI/DI each 10193489040685, UDI/DI case 30193489040689, Lot Number: 106258; Medline Kit Number/SKU 60012911: UDI/DI each 10193489040685, UDI/DI case 30193489040689, Lot Number: 114948; Medline Kit Number/SKU 60012911: UDI/DI each 10193489040685, UDI/DI case 30193489040689, Lot Number: 115856; Medline Kit Number/SKU 60012911: UDI/DI each 10193489040685, UDI/DI case 30193489040689, Lot Number: 129215; Medline Kit Number/SKU 60012911: UDI/DI each 10193489040685, UDI/DI case 30193489040689, Lot Number: 129501; Medline Kit Number/SKU 60012911: UDI/DI each 10193489040685, UDI/DI case 30193489040689, Lot Number: 131536; Medline Kit Number/SKU 60012911: UDI/DI each 10193489040685, UDI/DI case 30193489040689, Lot Number: 138730; Medline Kit Number/SKU 60012911: UDI/DI each 10193489040685, UDI/DI case 30193489040689, Lot Number: 143661; Medline Kit Number/SKU 60012911: UDI/DI each 10193489040685, UDI/DI case 30193489040689, Lot Number: 144820; Medline Kit Number/SKU 60012911: UDI/DI each 10193489040685, UDI/DI case 30193489040689, Lot Number: 145579; Medline Kit Number/SKU 60012911: UDI/DI each 10193489040685, UDI/DI case 30193489040689, Lot Number: 148112; Medline Kit Number/SKU 60012911: UDI/DI each 10193489040685, UDI/DI case 30193489040689, Lot Number: 150651; Medline Kit Number/SKU 60012911: UDI/DI each 10193489040685, UDI/DI case 30193489040689, Lot Number: 176144; Medline Kit Number/SKU 60012911: UDI/DI each 10193489040685, UDI/DI case 30193489040689, Lot Number: 188261; Medline Kit Number/SKU 60012912: UDI/DI each 10193489040692, UDI/DI case 30193489040696, Lot Number: 104011; Medline Kit Number/SKU 60012912: UDI/DI each 10193489040692, UDI/DI case 30193489040696, Lot Number: 119986; Medline Kit Number/SKU 60012912: UDI/DI each 10193489040692, UDI/DI case 30193489040696, Lot Number: 120336; Medline Kit Number/SKU 60012912: UDI/DI each 10193489040692, UDI/DI case 30193489040696, Lot Number: 122652; Medline Kit Number/SKU 60012912: UDI/DI each 10193489040692, UDI/DI case 30193489040696, Lot Number: 130946; Medline Kit Number/SKU 60012912: UDI/DI each 10193489040692, UDI/DI case 30193489040696, Lot Number: 149576; Medline Kit Number/SKU 60012912: UDI/DI each 10193489040692, UDI/DI case 30193489040696, Lot Number: 152390; Medline Kit Number/SKU 60012912: UDI/DI each 10193489040692, UDI/DI case 30193489040696, Lot Number: 153237; Medline Kit Number/SKU 60012912: UDI/DI each 10193489040692, UDI/DI case 30193489040696, Lot Number: 162759; Medline Kit Number/SKU 60012912: UDI/DI each 10193489040692, UDI/DI case 30193489040696, Lot Number: 164896; Medline Kit Number/SKU 60012912: UDI/DI each 10193489040692, UDI/DI case 30193489040696, Lot Number: 188361; Medline Kit Number/SKU 60013001: UDI/DI each 10193489040715, UDI/DI case 30193489040719, Lot Number: 93782; Medline Kit Number/SKU 60013001: UDI/DI each 10193489040715, UDI/DI case 30193489040719, Lot Number: 96363; Medline Kit Number/SKU 60013001: UDI/DI each 10193489040715, UDI/DI case 30193489040719, Lot Number: 97380; Medline Kit Number/SKU 60013001: UDI/DI each 10193489040715, UDI/DI case 30193489040719, Lot Number: 98743; Medline Kit Number/SKU 60013001: UDI/DI each 10193489040715, UDI/DI case 30193489040719, Lot Number: 105137; Medline Kit Number/SKU 60013001: UDI/DI each 10193489040715, UDI/DI case 30193489040719, Lot Number: 106046; Medline Kit Number/SKU 60013001: UDI/DI each 10193489040715, UDI/DI case 30193489040719, Lot Number: 111206; Medline Kit Number/SKU 60013001: UDI/DI each 10193489040715, UDI/DI case 30193489040719, Lot Number: 114190; Medline Kit Number/SKU 60013001: UDI/DI each 10193489040715, UDI/DI case 30193489040719, Lot Number: 115831; Medline Kit Number/SKU 60013001: UDI/DI each 10193489040715, UDI/DI case 30193489040719, Lot Number: 118695; Medline Kit Number/SKU 60013001: UDI/DI each 10193489040715, UDI/DI case 30193489040719, Lot Number: 123787; Medline Kit Number/SKU 60013001: UDI/DI each 10193489040715, UDI/DI case 30193489040719, Lot Number: 128251; Medline Kit Number/SKU 60013001: UDI/DI each 10193489040715, UDI/DI case 30193489040719, Lot Number: 133072; Medline Kit Number/SKU 60013001: UDI/DI each 10193489040715, UDI/DI case 30193489040719, Lot Number: 138228; Medline Kit Number/SKU 60013001: UDI/DI each 10193489040715, UDI/DI case 30193489040719, Lot Number: 140367; Medline Kit Number/SKU 60013001: UDI/DI each 10193489040715, UDI/DI case 30193489040719, Lot Number: 144535; Medline Kit Number/SKU 60013001: UDI/DI each 10193489040715, UDI/DI case 30193489040719, Lot Number: 149547; Medline Kit Number/SKU 60013001: UDI/DI each 10193489040715, UDI/DI case 30193489040719, Lot Number: 152488; Medline Kit Number/SKU 60013001: UDI/DI each 10193489040715, UDI/DI case 30193489040719, Lot Number: 155300; Medline Kit Number/SKU 60013001: UDI/DI each 10193489040715, UDI/DI case 30193489040719, Lot Number: 162783; Medline Kit Number/SKU 60013001: UDI/DI each 10193489040715, UDI/DI case 30193489040719, Lot Number: 166461; Medline Kit Number/SKU 60013001: UDI/DI each 10193489040715, UDI/DI case 30193489040719, Lot Number: 168363; Medline Kit Number/SKU 60013001: UDI/DI each 10193489040715, UDI/DI case 30193489040719, Lot Number: 168433; Medline Kit Number/SKU 60013101: UDI/DI each 10193489040746, UDI/DI case 30193489040740, Lot Number: 88809; Medline Kit Number/SKU 60013101: UDI/DI each 10193489040746, UDI/DI case 30193489040740, Lot Number: 93807; Medline Kit Number/SKU 60013101: UDI/DI each 10193489040746, UDI/DI case 30193489040740, Lot Number: 98370; Medline Kit Number/SKU 60013101: UDI/DI each 10193489040746, UDI/DI case 30193489040740, Lot Number: 102015; Medline Kit Number/SKU 60013101: UDI/DI each 10193489040746, UDI/DI case 30193489040740, Lot Number: 104687; Medline Kit Number/SKU 60013101: UDI/DI each 10193489040746, UDI/DI case 30193489040740, Lot Number: 107324; Medline Kit Number/SKU 60013101: UDI/DI each 10193489040746, UDI/DI case 30193489040740, Lot Number: 109984; Medline Kit Number/SKU 60013101: UDI/DI each 10193489040746, UDI/DI case 30193489040740, Lot Number: 116869; Medline Kit Number/SKU 60013101: UDI/DI each 10193489040746, UDI/DI case 30193489040740, Lot Number: 124230; Medline Kit Number/SKU 60013101: UDI/DI each 10193489040746, UDI/DI case 30193489040740, Lot Number: 129398; Medline Kit Number/SKU 60013101: UDI/DI each 10193489040746, UDI/DI case 30193489040740, Lot Number: 133867; Medline Kit Number/SKU 60013101: UDI/DI each 10193489040746, UDI/DI case 30193489040740, Lot Number: 156445; Medline Kit Number/SKU 60013101: UDI/DI each 10193489040746, UDI/DI case 30193489040740, Lot Number: 156915; Medline Kit Number/SKU 60013101: UDI/DI each 10193489040746, UDI/DI case 30193489040740, Lot Number: 160817; Medline Kit Number/SKU 60013112: UDI/DI each 10193489040753, UDI/DI case 30193489040757, Lot Number: 110228; Medline Kit Number/SKU 60013112: UDI/DI each 10193489040753, UDI/DI case 30193489040757, Lot Number: 112533; Medline Kit Number/SKU 60013112: UDI/DI each 10193489040753, UDI/DI case 30193489040757, Lot Number: 161094; Medline Kit Number/SKU 60020608: UDI/DI each 10193489091236, UDI/DI case 30193489091230, Lot Number: 91836; Medline Kit Number/SKU 60020608: UDI/DI each 10193489091236, UDI/DI case 30193489091230, Lot Number: 97142; Medline Kit Number/SKU 60020608: UDI/DI each 10193489091236, UDI/DI case 30193489091230, Lot Number: 98744; Medline Kit Number/SKU 60020608: UDI/DI each 10193489091236, UDI/DI case 30193489091230, Lot Number: 102810; Medline Kit Number/SKU 60020608: UDI/DI each 10193489091236, UDI/DI case 30193489091230, Lot Number: 105641; Medline Kit Number/SKU 60020608: UDI/DI each 10193489091236, UDI/DI case 30193489091230, Lot Number: 110931; Medline Kit Number/SKU 60020608: UDI/DI each 10193489091236, UDI/DI case 30193489091230, Lot Number: 114188; Medline Kit Number/SKU 60020608: UDI/DI each 10193489091236, UDI/DI case 30193489091230, Lot Number: 119364; Medline Kit Number/SKU 60020608: UDI/DI each 10193489091236, UDI/DI case 30193489091230, Lot Number: 122277; Medline Kit Number/SKU 60020608: UDI/DI each 10193489091236, UDI/DI case 30193489091230, Lot Number: 123026; Medline Kit Number/SKU 60020608: UDI/DI each 10193489091236, UDI/DI case 30193489091230, Lot Number: 130849; Medline Kit Number/SKU 60020608: UDI/DI each 10193489091236, UDI/DI case 30193489091230, Lot Number: 131983; Medline Kit Number/SKU 60020608: UDI/DI each 10193489091236, UDI/DI case 30193489091230, Lot Number: 136561; Medline Kit Number/SKU 60020608: UDI/DI each 10193489091236, UDI/DI case 30193489091230, Lot Number: 138724; Medline Kit Number/SKU 60020608: UDI/DI each 10193489091236, UDI/DI case 30193489091230, Lot Number: 140812; Medline Kit Number/SKU 60020608: UDI/DI each 10193489091236, UDI/DI case 30193489091230, Lot Number: 148499; Medline Kit Number/SKU 60020608: UDI/DI each 10193489091236, UDI/DI case 30193489091230, Lot Number: 151382; Medline Kit Number/SKU 60020608: UDI/DI each 10193489091236, UDI/DI case 30193489091230, Lot Number: 154050; Medline Kit Number/SKU 60020608: UDI/DI each 10193489091236, UDI/DI case 30193489091230, Lot Number: 159730; Medline Kit Number/SKU 60020608: UDI/DI each 10193489091236, UDI/DI case 30193489091230, Lot Number: 161133; Medline Kit Number/SKU 60020608: UDI/DI each 10193489091236, UDI/DI case 30193489091230, Lot Number: 165637; Medline Kit Number/SKU 60020608: UDI/DI each 10193489091236, UDI/DI case 30193489091230, Lot Number: 168673; Medline Kit Number/SKU 60020608: UDI/DI each 10193489091236, UDI/DI case 30193489091230, Lot Number: 169864; Medline Kit Number/SKU 60020608: UDI/DI each 10193489091236, UDI/DI case 30193489091230, Lot Number: 174919; Medline Kit Number/SKU 60020608: UDI/DI each 10193489091236, UDI/DI case 30193489091230, Lot Number: 178181; Medline Kit Number/SKU 60020608: UDI/DI each 10193489091236, UDI/DI case 30193489091230, Lot Number: 179538; Medline Kit Number/SKU 60020608: UDI/DI each 10193489091236, UDI/DI case 30193489091230, Lot Number: 182044; Medline Kit Number/SKU 60020608: UDI/DI each 10193489091236, UDI/DI case 30193489091230, Lot Number: 188260; Medline Kit Number/SKU 60032681: UDI/DI each 10193489042351, UDI/DI case 30193489042355, Lot Number: 91621; Medline Kit Number/SKU 60033123: UDI/DI each 10193489042436, UDI/DI case 30193489042430, Lot Number: 90165; Medline Kit Number/SKU 60033123: UDI/DI each 10193489042436, UDI/DI case 30193489042430, Lot Number: 92346; Medline Kit Number/SKU 60033123: UDI/DI each 10193489042436, UDI/DI case 30193489042430, Lot Number: 94178; Medline Kit Number/SKU 60033123: UDI/DI each 10193489042436, UDI/DI case 30193489042430, Lot Number: 95748; Medline Kit Number/SKU 60033123: UDI/DI each 10193489042436, UDI/DI case 30193489042430, Lot Number: 97899; Medline Kit Number/SKU 60033123: UDI/DI each 10193489042436, UDI/DI case 30193489042430, Lot Number: 98731; Medline Kit Number/SKU 60033123: UDI/DI each 10193489042436, UDI/DI case 30193489042430, Lot Number: 101209; Medline Kit Number/SKU 60033123: UDI/DI each 10193489042436, UDI/DI case 30193489042430, Lot Number: 104020; Medline Kit Number/SKU 60033123: UDI/DI each 10193489042436, UDI/DI case 30193489042430, Lot Number: 105502; Medline Kit Number/SKU 60033123: UDI/DI each 10193489042436, UDI/DI case 30193489042430, Lot Number: 109602; Medline Kit Number/SKU 60033123: UDI/DI each 10193489042436, UDI/DI case 30193489042430, Lot Number: 114204; Medline Kit Number/SKU 60033123: UDI/DI each 10193489042436, UDI/DI case 30193489042430, Lot Number: 118543; Medline Kit Number/SKU 60033123: UDI/DI each 10193489042436, UDI/DI case 30193489042430, Lot Number: 118554; Medline Kit Number/SKU 60033123: UDI/DI each 10193489042436, UDI/DI case 30193489042430, Lot Number: 118685; Medline Kit Number/SKU 60033123: UDI/DI each 10193489042436, UDI/DI case 30193489042430, Lot Number: 124471; Medline Kit Number/SKU 60033123: UDI/DI each 10193489042436, UDI/DI case 30193489042430, Lot Number: 127944; Medline Kit Number/SKU 60033123: UDI/DI each 10193489042436, UDI/DI case 30193489042430, Lot Number: 131860; Medline Kit Number/SKU 60033123: UDI/DI each 10193489042436, UDI/DI case 30193489042430, Lot Number: 133868; Medline Kit Number/SKU 60033123: UDI/DI each 10193489042436, UDI/DI case 30193489042430, Lot Number: 139244; Medline Kit Number/SKU 60033123: UDI/DI each 10193489042436, UDI/DI case 30193489042430, Lot Number: 141280; Medline Kit Number/SKU 60033123: UDI/DI each 10193489042436, UDI/DI case 30193489042430, Lot Number: 145234; Medline Kit Number/SKU 60033123: UDI/DI each 10193489042436, UDI/DI case 30193489042430, Lot Number: 149064; Medline Kit Number/SKU 60033124: UDI/DI each 10193489042443, UDI/DI case 30193489042447, Lot Number: 98710; Medline Kit Number/SKU 60033124: UDI/DI each 10193489042443, UDI/DI case 30193489042447, Lot Number: 114002; Medline Kit Number/SKU 60033124: UDI/DI each 10193489042443, UDI/DI case 30193489042447, Lot Number: 117653; Medline Kit Number/SKU 60033124: UDI/DI each 10193489042443, UDI/DI case 30193489042447, Lot Number: 152098; Medline Kit Number/SKU 60033124: UDI/DI each 10193489042443, UDI/DI case 30193489042447, Lot Number: 156448; Medline Kit Number/SKU 60033124: UDI/DI each 10193489042443, UDI/DI case 30193489042447, Lot Number: 157222; Medline Kit Number/SKU 60033124: UDI/DI each 10193489042443, UDI/DI case 30193489042447, Lot Number: 161918; Medline Kit Number/SKU 60034644: UDI/DI each 10193489042580, UDI/DI case 30193489042584, Lot Number: 89558; Medline Kit Number/SKU 60034644: UDI/DI each 10193489042580, UDI/DI case 30193489042584, Lot Number: 109996; Medline Kit Number/SKU 60034644: UDI/DI each 10193489042580, UDI/DI case 30193489042584, Lot Number: 118697; Medline Kit Number/SKU 60034644: UDI/DI each 10193489042580, UDI/DI case 30193489042584, Lot Number: 132131; Medline Kit Number/SKU 60034644: UDI/DI each 10193489042580, UDI/DI case 30193489042584, Lot Number: 145960; Medline Kit Number/SKU 60034644: UDI/DI each 10193489042580, UDI/DI case 30193489042584, Lot Number: 154989; Medline Kit Number/SKU 60034644: UDI/DI each 10193489042580, UDI/DI case 30193489042584, Lot Number: 176185; Medline Kit Number/SKU 60034644: UDI/DI each 10193489042580, UDI/DI case 30193489042584, Lot Number: 192611; Medline Kit Number/SKU 60040273: UDI/DI each 10193489042832, UDI/DI case 30193489042836, Lot Number: 93733; Medline Kit Number/SKU 60040273: UDI/DI each 10193489042832, UDI/DI case 30193489042836, Lot Number: 95366; Medline Kit Number/SKU 60040273: UDI/DI each 10193489042832, UDI/DI case 30193489042836, Lot Number: 97021; Medline Kit Number/SKU 60040273: UDI/DI each 10193489042832, UDI/DI case 30193489042836, Lot Number: 97144; Medline Kit Number/SKU 60040273: UDI/DI each 10193489042832, UDI/DI case 30193489042836, Lot Number: 98758; Medline Kit Number/SKU 60040273: UDI/DI each 10193489042832, UDI/DI case 30193489042836, Lot Number: 100158; Medline Kit Number/SKU 60040273: UDI/DI each 10193489042832, UDI/DI case 30193489042836, Lot Number: 100285; Medline Kit Number/SKU 60040273: UDI/DI each 10193489042832, UDI/DI case 30193489042836, Lot Number: 103508; Medline Kit Number/SKU 60040273: UDI/DI each 10193489042832, UDI/DI case 30193489042836, Lot Number: 106037; Medline Kit Number/SKU 60040273: UDI/DI each 10193489042832, UDI/DI case 30193489042836, Lot Number: 115791; Medline Kit Number/SKU 60040273: UDI/DI each 10193489042832, UDI/DI case 30193489042836, Lot Number: 115938; Medline Kit Number/SKU 60040273: UDI/DI each 10193489042832, UDI/DI case 30193489042836, Lot Number: 118192; Medline Kit Number/SKU 60040273: UDI/DI each 10193489042832, UDI/DI case 30193489042836, Lot Number: 123857; Medline Kit Number/SKU 60040273: UDI/DI each 10193489042832, UDI/DI case 30193489042836, Lot Number: 128244; Medline Kit Number/SKU 60040273: UDI/DI each 10193489042832, UDI/DI case 30193489042836, Lot Number: 132367; Medline Kit Number/SKU 60040273: UDI/DI each 10193489042832, UDI/DI case 30193489042836, Lot Number: 133069; Medline Kit Number/SKU 60040273: UDI/DI each 10193489042832, UDI/DI case 30193489042836, Lot Number: 137490; Medline Kit Number/SKU 60040273: UDI/DI each 10193489042832, UDI/DI case 30193489042836, Lot Number: 140896; Medline Kit Number/SKU 60040273: UDI/DI each 10193489042832, UDI/DI case 30193489042836, Lot Number: 145545; Medline Kit Number/SKU 60040273: UDI/DI each 10193489042832, UDI/DI case 30193489042836, Lot Number: 148439; Medline Kit Number/SKU 60040273: UDI/DI each 10193489042832, UDI/DI case 30193489042836, Lot Number: 149175; Medline Kit Number/SKU 60040273: UDI/DI each 10193489042832, UDI/DI case 30193489042836, Lot Number: 153015; Medline Kit Number/SKU 60040273: UDI/DI each 10193489042832, UDI/DI case 30193489042836, Lot Number: 154538; Medline Kit Number/SKU 60040273: UDI/DI each 10193489042832, UDI/DI case 30193489042836, Lot Number: 162383; Medline Kit Number/SKU 60040273: UDI/DI each 10193489042832, UDI/DI case 30193489042836, Lot Number: 169029; Medline Kit Number/SKU 60040273: UDI/DI each 10193489042832, UDI/DI case 30193489042836, Lot Number: 171860; Medline Kit Number/SKU 60040273: UDI/DI each 10193489042832, UDI/DI case 30193489042836, Lot Number: 172058; Medline Kit Number/SKU 60040273: UDI/DI each 10193489042832, UDI/DI case 30193489042836, Lot Number: 179872; Medline Kit Number/SKU 60040273: UDI/DI each 10193489042832, UDI/DI case 30193489042836, Lot Number: 183375; Medline Kit Number/SKU 60040273: UDI/DI each 10193489042832, UDI/DI case 30193489042836, Lot Number: 187369; Medline Kit Number/SKU 60040273: UDI/DI each 10193489042832, UDI/DI case 30193489042836, Lot Number: 188866; Medline Kit Number/SKU 60040273: UDI/DI each 10193489042832, UDI/DI case 30193489042836, Lot Number: 189915; Medline Kit Number/SKU 60040424: UDI/DI each 10193489042900, UDI/DI case 20193489042907, Lot Number: 96014; Medline Kit Number/SKU 60040424: UDI/DI each 10193489042900, UDI/DI case 20193489042907, Lot Number: 97846; Medline Kit Number/SKU 60040424: UDI/DI each 10193489042900, UDI/DI case 20193489042907, Lot Number: 116943; Medline Kit Number/SKU 60040424: UDI/DI each 10193489042900, UDI/DI case 20193489042907, Lot Number: 119653; Medline Kit Number/SKU 60040424: UDI/DI each 10193489042900, UDI/DI case 20193489042907, Lot Number: 137248; Medline Kit Number/SKU 60040424: UDI/DI each 10193489042900, UDI/DI case 20193489042907, Lot Number: 141314; Medline Kit Number/SKU 60040424: UDI/DI each 10193489042900, UDI/DI case 20193489042907, Lot Number: 160096; Medline Kit Number/SKU 60040424: UDI/DI each 10193489042900, UDI/DI case 20193489042907, Lot Number: 169412; Medline Kit Number/SKU 60040424: UDI/DI each 10193489042900, UDI/DI case 20193489042907, Lot Number: 170710; Medline Kit Number/SKU 60040424: UDI/DI each 10193489042900, UDI/DI case 20193489042907, Lot Number: 176826; Medline Kit Number/SKU 60040424: UDI/DI each 10193489042900, UDI/DI case 20193489042907, Lot Number: 179557; Medline Kit Number/SKU 60040424: UDI/DI each 10193489042900, UDI/DI case 20193489042907, Lot Number: 181885; Medline Kit Number/SKU 60040424: UDI/DI each 10193489042900, UDI/DI case 20193489042907, Lot Number: 188252; Medline Kit Number/SKU 60040424: UDI/DI each 10193489042900, UDI/DI case 20193489042907, Lot Number: 188731; Medline Kit Number/SKU 60040424: UDI/DI each 10193489042900, UDI/DI case 20193489042907, Lot Number: 194036; Medline Kit Number/SKU 60041082: UDI/DI each 10193489043006, UDI/DI case 30193489043000, Lot Number: 89747; Medline Kit Number/SKU 60041082: UDI/DI each 10193489043006, UDI/DI case 30193489043000, Lot Number: 90431; Medline Kit Number/SKU 60041082: UDI/DI each 10193489043006, UDI/DI case 30193489043000, Lot Number: 93432; Medline Kit Number/SKU 60041082: UDI/DI each 10193489043006, UDI/DI case 30193489043000, Lot Number: 95362; Medline Kit Number/SKU 60041082: UDI/DI each 10193489043006, UDI/DI case 30193489043000, Lot Number: 99945; Medline Kit Number/SKU 60041082: UDI/DI each 10193489043006, UDI/DI case 30193489043000, Lot Number: 99946; Medline Kit Number/SKU 60041082: UDI/DI each 10193489043006, UDI/DI case 30193489043000, Lot Number: 102173; Medline Kit Number/SKU 60041082: UDI/DI each 10193489043006, UDI/DI case 30193489043000, Lot Number: 111165; Medline Kit Number/SKU 60041082: UDI/DI each 10193489043006, UDI/DI case 30193489043000, Lot Number: 113255; Medline Kit Number/SKU 60041082: UDI/DI each 10193489043006, UDI/DI case 30193489043000, Lot Number: 115375; Medline Kit Number/SKU 60041082: UDI/DI each 10193489043006, UDI/DI case 30193489043000, Lot Number: 115727; Medline Kit Number/SKU 60041082: UDI/DI each 10193489043006, UDI/DI case 30193489043000, Lot Number: 118600; Medline Kit Number/SKU 60042453: UDI/DI each 10193489043150, UDI/DI case 30193489043154, Lot Number: 90432; Medline Kit Number/SKU 60042453: UDI/DI each 10193489043150, UDI/DI case 30193489043154, Lot Number: 114640; Medline Kit Number/SKU 60042453: UDI/DI each 10193489043150, UDI/DI case 30193489043154, Lot Number: 114693; Medline Kit Number/SKU 60042453: UDI/DI each 10193489043150, UDI/DI case 30193489043154, Lot Number: 156827; Medline Kit Number/SKU 60042453: UDI/DI each 10193489043150, UDI/DI case 30193489043154, Lot Number: 162761; Medline Kit Number/SKU 60042453: UDI/DI each 10193489043150, UDI/DI case 30193489043154, Lot Number: 184028; Medline Kit Number/SKU 60042453: UDI/DI each 10193489043150, UDI/DI case 30193489043154, Lot Number: 184433; Medline Kit Number/SKU 60042454: UDI/DI each 10193489043167, UDI/DI case 20193489043164, Lot Number: 103077; Medline Kit Number/SKU 60042454: UDI/DI each 10193489043167, UDI/DI case 20193489043164, Lot Number: 105514; Medline Kit Number/SKU 60042454: UDI/DI each 10193489043167, UDI/DI case 20193489043164, Lot Number: 129200; Medline Kit Number/SKU 60042454: UDI/DI each 10193489043167, UDI/DI case 20193489043164, Lot Number: 130614; Medline Kit Number/SKU 60042454: UDI/DI each 10193489043167, UDI/DI case 20193489043164, Lot Number: 161885; Medline Kit Number/SKU 60042454: UDI/DI each 10193489043167, UDI/DI case 20193489043164, Lot Number: 163536; Medline Kit Number/SKU 60042454: UDI/DI each 10193489043167, UDI/DI case 20193489043164, Lot Number: 174742; Medline Kit Number/SKU 60042454: UDI/DI each 10193489043167, UDI/DI case 20193489043164, Lot Number: 175617; Medline Kit Number/SKU 60042454: UDI/DI each 10193489043167, UDI/DI case 20193489043164, Lot Number: 181137; Medline Kit Number/SKU 60042721: UDI/DI each 10193489043174, UDI/DI case 30193489043178, Lot Number: 91826; Medline Kit Number/SKU 60042721: UDI/DI each 10193489043174, UDI/DI case 30193489043178, Lot Number: 94859; Medline Kit Number/SKU 60042721: UDI/DI each 10193489043174, UDI/DI case 30193489043178, Lot Number: 109994; Medline Kit Number/SKU 60042721: UDI/DI each 10193489043174, UDI/DI case 30193489043178, Lot Number: 115796; Medline Kit Number/SKU 60042721: UDI/DI each 10193489043174, UDI/DI case 30193489043178, Lot Number: 118026; Medline Kit Number/SKU 60042721: UDI/DI each 10193489043174, UDI/DI case 30193489043178, Lot Number: 124170; Medline Kit Number/SKU 60042721: UDI/DI each 10193489043174, UDI/DI case 30193489043178, Lot Number: 137944; Medline Kit Number/SKU 60042721: UDI/DI each 10193489043174, UDI/DI case 30193489043178, Lot Number: 145441; Medline Kit Number/SKU 60042721: UDI/DI each 10193489043174, UDI/DI case 30193489043178, Lot Number: 153696; Medline Kit Number/SKU 60042721: UDI/DI each 10193489043174, UDI/DI case 30193489043178, Lot Number: 158858; Medline Kit Number/SKU 60042721: UDI/DI each 10193489043174, UDI/DI case 30193489043178, Lot Number: 162927; Medline Kit Number/SKU 60042721: UDI/DI each 10193489043174, UDI/DI case 30193489043178, Lot Number: 167645; Medline Kit Number/SKU 60042721: UDI/DI each 10193489043174, UDI/DI case 30193489043178, Lot Number: 173222; Medline Kit Number/SKU 60050183: UDI/DI each 10193489043273, UDI/DI case 30193489043277, Lot Number: 87997; Medline Kit Number/SKU 60050183: UDI/DI each 10193489043273, UDI/DI case 30193489043277, Lot Number: 91709; Medline Kit Number/SKU 60050183: UDI/DI each 10193489043273, UDI/DI case 30193489043277, Lot Number: 93429; Medline Kit Number/SKU 60050183: UDI/DI each 10193489043273, UDI/DI case 30193489043277, Lot Number: 98728; Medline Kit Number/SKU 60050183: UDI/DI each 10193489043273, UDI/DI case 30193489043277, Lot Number: 99066; Medline Kit Number/SKU 60050183: UDI/DI each 10193489043273, UDI/DI case 30193489043277, Lot Number: 106096; Medline Kit Number/SKU 60050183: UDI/DI each 10193489043273, UDI/DI case 30193489043277, Lot Number: 108172; Medline Kit Number/SKU 60050183: UDI/DI each 10193489043273, UDI/DI case 30193489043277, Lot Number: 115717; Medline Kit Number/SKU 60050183: UDI/DI each 10193489043273, UDI/DI case 30193489043277, Lot Number: 115718; Medline Kit Number/SKU 60050183: UDI/DI each 10193489043273, UDI/DI case 30193489043277, Lot Number: 116439; Medline Kit Number/SKU 60050183: UDI/DI each 10193489043273, UDI/DI case 30193489043277, Lot Number: 120538; Medline Kit Number/SKU 60050183: UDI/DI each 10193489043273, UDI/DI case 30193489043277, Lot Number: 126638; Medline Kit Number/SKU 60050183: UDI/DI each 10193489043273, UDI/DI case 30193489043277, Lot Number: 128698; Medline Kit Number/SKU 60050183: UDI/DI each 10193489043273, UDI/DI case 30193489043277, Lot Number: 130991; Medline Kit Number/SKU 60050183: UDI/DI each 10193489043273, UDI/DI case 30193489043277, Lot Number: 131369; Medline Kit Number/SKU 60050183: UDI/DI each 10193489043273, UDI/DI case 30193489043277, Lot Number: 135363; Medline Kit Number/SKU 60050183: UDI/DI each 10193489043273, UDI/DI case 30193489043277, Lot Number: 148880; Medline Kit Number/SKU 60060268: UDI/DI each 10193489043648, UDI/DI case 30193489043642, Lot Number: 89836; Medline Kit Number/SKU 60060268: UDI/DI each 10193489043648, UDI/DI case 30193489043642, Lot Number: 101173; Medline Kit Number/SKU 60060268: UDI/DI each 10193489043648, UDI/DI case 30193489043642, Lot Number: 107517; Medline Kit Number/SKU 60060268: UDI/DI each 10193489043648, UDI/DI case 30193489043642, Lot Number: 114651; Medline Kit Number/SKU 60060268: UDI/DI each 10193489043648, UDI/DI case 30193489043642, Lot Number: 116405; Medline Kit Number/SKU 60060268: UDI/DI each 10193489043648, UDI/DI case 30193489043642, Lot Number: 120766; Medline Kit Number/SKU 60060268: UDI/DI each 10193489043648, UDI/DI case 30193489043642, Lot Number: 157701; Medline Kit Number/
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.