Class IOngoingZ-2145-2026

Medline Industries, LP recalls 1. 3 VALVE MAN KIT

Medline Industries, LPNorthfield, IL, United StatesReported May 20, 2026 · 1 month ago

By Taylor Coteus

Legal News Analyst · May 20, 2026

Reason for recall

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

Affected product

Check your device

Enter a lot, serial, REF, or UDI number from your device's label to check it against this recall's listed codes.

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

Lot / code information

Lot #: 91637; Medline Kit Number/SKU 60010195: UDI/DI each 10193489040234, UDI/DI case 30193489040238
Lot #: 91667; Medline Kit Number/SKU 60010195: UDI/DI each 10193489040234, UDI/DI case 30193489040238
Lot #: 92995; Medline Kit Number/SKU 60010195: UDI/DI each 10193489040234, UDI/DI case 30193489040238
Lot #: 95615; Medline Kit Number/SKU 60010195: UDI/DI each 10193489040234, UDI/DI case 30193489040238
Lot #: 97091; Medline Kit Number/SKU 60010195: UDI/DI each 10193489040234, UDI/DI case 30193489040238
Lot #: 102177; Medline Kit Number/SKU 60010195: UDI/DI each 10193489040234, UDI/DI case 30193489040238
Lot #: 104282; Medline Kit Number/SKU 60010195: UDI/DI each 10193489040234, UDI/DI case 30193489040238
Lot #: 108922; Medline Kit Number/SKU 60010195: UDI/DI each 10193489040234, UDI/DI case 30193489040238
Lot #: 110250; Medline Kit Number/SKU 60010468: UDI/DI each 10193489040319, UDI/DI case 30193489040313
Lot #: 89290; Medline Kit Number/SKU 60010468: UDI/DI each 10193489040319, UDI/DI case 30193489040313

Additional code information

SKU 60060268: UDI/DI each 10193489043648, UDI/DI case 30193489043642, Lot Number: 160090; Medline Kit Number/SKU 60060268: UDI/DI each 10193489043648, UDI/DI case 30193489043642, Lot Number: 161117; Medline Kit Number/SKU 60060268: UDI/DI each 10193489043648, UDI/DI case 30193489043642, Lot Number: 166925; Medline Kit Number/SKU 60060268: UDI/DI each 10193489043648, UDI/DI case 30193489043642, Lot Number: 170076; Medline Kit Number/SKU 60060268: UDI/DI each 10193489043648, UDI/DI case 30193489043642, Lot Number: 180887; Medline Kit Number/SKU 60060268: UDI/DI each 10193489043648, UDI/DI case 30193489043642, Lot Number: 184722; Medline Kit Number/SKU 60060268: UDI/DI each 10193489043648, UDI/DI case 30193489043642, Lot Number: 190126; Medline Kit Number/SKU 60060268: UDI/DI each 10193489043648, UDI/DI case 30193489043642, Lot Number: 193748; Medline Kit Number/SKU 60060564: UDI/DI each 10193489043785, UDI/DI case 30193489043789, Lot Number: 103990; Medline Kit Number/SKU 60060569: UDI/DI each 10193489043808, UDI/DI case 30193489043802, Lot Number: 88242; Medline Kit Number/SKU 60060569: UDI/DI each 10193489043808, UDI/DI case 30193489043802, Lot Number: 90780; Medline Kit Number/SKU 60060569: UDI/DI each 10193489043808, UDI/DI case 30193489043802, Lot Number: 103093; Medline Kit Number/SKU 60060569: UDI/DI each 10193489043808, UDI/DI case 30193489043802, Lot Number: 104695; Medline Kit Number/SKU 60060569: UDI/DI each 10193489043808, UDI/DI case 30193489043802, Lot Number: 107656; Medline Kit Number/SKU 60060569: UDI/DI each 10193489043808, UDI/DI case 30193489043802, Lot Number: 111209; Medline Kit Number/SKU 60060569: UDI/DI each 10193489043808, UDI/DI case 30193489043802, Lot Number: 114196; Medline Kit Number/SKU 60060569: UDI/DI each 10193489043808, UDI/DI case 30193489043802, Lot Number: 120010; Medline Kit Number/SKU 60060569: UDI/DI each 10193489043808, UDI/DI case 30193489043802, Lot Number: 122243; Medline Kit Number/SKU 60060569: UDI/DI each 10193489043808, UDI/DI case 30193489043802, Lot Number: 123717; Medline Kit Number/SKU 60060569: UDI/DI each 10193489043808, UDI/DI case 30193489043802, Lot Number: 140235; Medline Kit Number/SKU 60060569: UDI/DI each 10193489043808, UDI/DI case 30193489043802, Lot Number: 152102; Medline Kit Number/SKU 60060569: UDI/DI each 10193489043808, UDI/DI case 30193489043802, Lot Number: 175648; Medline Kit Number/SKU 60060569: UDI/DI each 10193489043808, UDI/DI case 30193489043802, Lot Number: 181448; Medline Kit Number/SKU 60060569: UDI/DI each 10193489043808, UDI/DI case 30193489043802, Lot Number: 184715; Medline Kit Number/SKU 60060569: UDI/DI each 10193489043808, UDI/DI case 30193489043802, Lot Number: 186911; Medline Kit Number/SKU 60060569: UDI/DI each 10193489043808, UDI/DI case 30193489043802, Lot Number: 190137; Medline Kit Number/SKU 60060569: UDI/DI each 10193489043808, UDI/DI case 30193489043802, Lot Number: 193277; Medline Kit Number/SKU 60062021: UDI/DI each 10193489043952, UDI/DI case 30193489043956, Lot Number: 87649; Medline Kit Number/SKU 60062021: UDI/DI each 10193489043952, UDI/DI case 30193489043956, Lot Number: 89265; Medline Kit Number/SKU 60062021: UDI/DI each 10193489043952, UDI/DI case 30193489043956, Lot Number: 94877; Medline Kit Number/SKU 60062021: UDI/DI each 10193489043952, UDI/DI case 30193489043956, Lot Number: 97758; Medline Kit Number/SKU 60062021: UDI/DI each 10193489043952, UDI/DI case 30193489043956, Lot Number: 105585; Medline Kit Number/SKU 60062021: UDI/DI each 10193489043952, UDI/DI case 30193489043956, Lot Number: 110924; Medline Kit Number/SKU 60062021: UDI/DI each 10193489043952, UDI/DI case 30193489043956, Lot Number: 115830; Medline Kit Number/SKU 60062021: UDI/DI each 10193489043952, UDI/DI case 30193489043956, Lot Number: 123872; Medline Kit Number/SKU 60062021: UDI/DI each 10193489043952, UDI/DI case 30193489043956, Lot Number: 126648; Medline Kit Number/SKU 60062021: UDI/DI each 10193489043952, UDI/DI case 30193489043956, Lot Number: 129619; Medline Kit Number/SKU 60062021: UDI/DI each 10193489043952, UDI/DI case 30193489043956, Lot Number: 133585; Medline Kit Number/SKU 60062021: UDI/DI each 10193489043952, UDI/DI case 30193489043956, Lot Number: 148078; Medline Kit Number/SKU 60062021: UDI/DI each 10193489043952, UDI/DI case 30193489043956, Lot Number: 150632; Medline Kit Number/SKU 60062021: UDI/DI each 10193489043952, UDI/DI case 30193489043956, Lot Number: 153356; Medline Kit Number/SKU 60062021: UDI/DI each 10193489043952, UDI/DI case 30193489043956, Lot Number: 156877; Medline Kit Number/SKU 60062021: UDI/DI each 10193489043952, UDI/DI case 30193489043956, Lot Number: 166259; Medline Kit Number/SKU 60062021: UDI/DI each 10193489043952, UDI/DI case 30193489043956, Lot Number: 170025; Medline Kit Number/SKU 60062021: UDI/DI each 10193489043952, UDI/DI case 30193489043956, Lot Number: 181558; Medline Kit Number/SKU 60071232: UDI/DI each 10193489044317, UDI/DI case 30193489044311, Lot Number: 88571; Medline Kit Number/SKU 60071232: UDI/DI each 10193489044317, UDI/DI case 30193489044311, Lot Number: 91924; Medline Kit Number/SKU 60071232: UDI/DI each 10193489044317, UDI/DI case 30193489044311, Lot Number: 92272; Medline Kit Number/SKU 60071232: UDI/DI each 10193489044317, UDI/DI case 30193489044311, Lot Number: 101088; Medline Kit Number/SKU 60071232: UDI/DI each 10193489044317, UDI/DI case 30193489044311, Lot Number: 101115; Medline Kit Number/SKU 60071232: UDI/DI each 10193489044317, UDI/DI case 30193489044311, Lot Number: 105942; Medline Kit Number/SKU 60071232: UDI/DI each 10193489044317, UDI/DI case 30193489044311, Lot Number: 135310; Medline Kit Number/SKU 60071232: UDI/DI each 10193489044317, UDI/DI case 30193489044311, Lot Number: 151096; Medline Kit Number/SKU 60071232: UDI/DI each 10193489044317, UDI/DI case 30193489044311, Lot Number: 152050; Medline Kit Number/SKU 60071232: UDI/DI each 10193489044317, UDI/DI case 30193489044311, Lot Number: 157870; Medline Kit Number/SKU 60071232: UDI/DI each 10193489044317, UDI/DI case 30193489044311, Lot Number: 157872; Medline Kit Number/SKU 60071232: UDI/DI each 10193489044317, UDI/DI case 30193489044311, Lot Number: 160093; Medline Kit Number/SKU 60071232: UDI/DI each 10193489044317, UDI/DI case 30193489044311, Lot Number: 160414; Medline Kit Number/SKU 60071232: UDI/DI each 10193489044317, UDI/DI case 30193489044311, Lot Number: 163941; Medline Kit Number/SKU 60071232: UDI/DI each 10193489044317, UDI/DI case 30193489044311, Lot Number: 165264; Medline Kit Number/SKU 60071232: UDI/DI each 10193489044317, UDI/DI case 30193489044311, Lot Number: 181384; Medline Kit Number/SKU 60071232: UDI/DI each 10193489044317, UDI/DI case 30193489044311, Lot Number: 182298; Medline Kit Number/SKU 60071232: UDI/DI each 10193489044317, UDI/DI case 30193489044311, Lot Number: 183032; Medline Kit Number/SKU 60071232: UDI/DI each 10193489044317, UDI/DI case 30193489044311, Lot Number: 184050; Medline Kit Number/SKU 60071232: UDI/DI each 10193489044317, UDI/DI case 30193489044311, Lot Number: 192624; Medline Kit Number/SKU 60080221: UDI/DI each 10193489044508, UDI/DI case 30193489044502, Lot Number: 123063; Medline Kit Number/SKU 60080221: UDI/DI each 10193489044508, UDI/DI case 30193489044502, Lot Number: 130969; Medline Kit Number/SKU 60080221: UDI/DI each 10193489044508, UDI/DI case 30193489044502, Lot Number: 132326; Medline Kit Number/SKU 60080221: UDI/DI each 10193489044508, UDI/DI case 30193489044502, Lot Number: 154569; Medline Kit Number/SKU 60080221: UDI/DI each 10193489044508, UDI/DI case 30193489044502, Lot Number: 156481; Medline Kit Number/SKU 60080221: UDI/DI each 10193489044508, UDI/DI case 30193489044502, Lot Number: 179809; Medline Kit Number/SKU 60080221: UDI/DI each 10193489044508, UDI/DI case 30193489044502, Lot Number: 181820; Medline Kit Number/SKU 60080221: UDI/DI each 10193489044508, UDI/DI case 30193489044502, Lot Number: 188733; Medline Kit Number/SKU 60080347: UDI/DI each 10193489044515, UDI/DI case 20193489044512, Lot Number: 105309; Medline Kit Number/SKU 60080347: UDI/DI each 10193489044515, UDI/DI case 20193489044512, Lot Number: 115441; Medline Kit Number/SKU 60080347: UDI/DI each 10193489044515, UDI/DI case 20193489044512, Lot Number: 127003; Medline Kit Number/SKU 60080347: UDI/DI each 10193489044515, UDI/DI case 20193489044512, Lot Number: 127750; Medline Kit Number/SKU 60080347: UDI/DI each 10193489044515, UDI/DI case 20193489044512, Lot Number: 131348; Medline Kit Number/SKU 60080347: UDI/DI each 10193489044515, UDI/DI case 20193489044512, Lot Number: 133116; Medline Kit Number/SKU 60080347: UDI/DI each 10193489044515, UDI/DI case 20193489044512, Lot Number: 139409; Medline Kit Number/SKU 60080347: UDI/DI each 10193489044515, UDI/DI case 20193489044512, Lot Number: 142786; Medline Kit Number/SKU 60080347: UDI/DI each 10193489044515, UDI/DI case 20193489044512, Lot Number: 146292; Medline Kit Number/SKU 60080347: UDI/DI each 10193489044515, UDI/DI case 20193489044512, Lot Number: 153926; Medline Kit Number/SKU 60080347: UDI/DI each 10193489044515, UDI/DI case 20193489044512, Lot Number: 155320; Medline Kit Number/SKU 60080347: UDI/DI each 10193489044515, UDI/DI case 20193489044512, Lot Number: 157925; Medline Kit Number/SKU 60080347: UDI/DI each 10193489044515, UDI/DI case 20193489044512, Lot Number: 164334; Medline Kit Number/SKU 60080347: UDI/DI each 10193489044515, UDI/DI case 20193489044512, Lot Number: 168619; Medline Kit Number/SKU 60080347: UDI/DI each 10193489044515, UDI/DI case 20193489044512, Lot Number: 175662; Medline Kit Number/SKU 60080347: UDI/DI each 10193489044515, UDI/DI case 20193489044512, Lot Number: 179502; Medline Kit Number/SKU 60080347: UDI/DI each 10193489044515, UDI/DI case 20193489044512, Lot Number: 181788; Medline Kit Number/SKU 60080347: UDI/DI each 10193489044515, UDI/DI case 20193489044512, Lot Number: 182251; Medline Kit Number/SKU 60080347: UDI/DI each 10193489044515, UDI/DI case 20193489044512, Lot Number: 182928; Medline Kit Number/SKU 60080347: UDI/DI each 10193489044515, UDI/DI case 20193489044512, Lot Number: 184022; Medline Kit Number/SKU 60080347: UDI/DI each 10193489044515, UDI/DI case 20193489044512, Lot Number: 185081; Medline Kit Number/SKU 60080347: UDI/DI each 10193489044515, UDI/DI case 20193489044512, Lot Number: 186824; Medline Kit Number/SKU 60080349: UDI/DI each 10193489044539, UDI/DI case 30193489044533, Lot Number: 92279; Medline Kit Number/SKU 60080349: UDI/DI each 10193489044539, UDI/DI case 30193489044533, Lot Number: 93452; Medline Kit Number/SKU 60080349: UDI/DI each 10193489044539, UDI/DI case 30193489044533, Lot Number: 95963; Medline Kit Number/SKU 60080349: UDI/DI each 10193489044539, UDI/DI case 30193489044533, Lot Number: 101955; Medline Kit Number/SKU 60080349: UDI/DI each 10193489044539, UDI/DI case 30193489044533, Lot Number: 105358; Medline Kit Number/SKU 60080349: UDI/DI each 10193489044539, UDI/DI case 30193489044533, Lot Number: 105526; Medline Kit Number/SKU 60080349: UDI/DI each 10193489044539, UDI/DI case 30193489044533, Lot Number: 109025; Medline Kit Number/SKU 60080349: UDI/DI each 10193489044539, UDI/DI case 30193489044533, Lot Number: 110885; Medline Kit Number/SKU 60080349: UDI/DI each 10193489044539, UDI/DI case 30193489044533, Lot Number: 115514; Medline Kit Number/SKU 60080349: UDI/DI each 10193489044539, UDI/DI case 30193489044533, Lot Number: 116413; Medline Kit Number/SKU 60080349: UDI/DI each 10193489044539, UDI/DI case 30193489044533, Lot Number: 124314; Medline Kit Number/SKU 60080349: UDI/DI each 10193489044539, UDI/DI case 30193489044533, Lot Number: 129174; Medline Kit Number/SKU 60080349: UDI/DI each 10193489044539, UDI/DI case 30193489044533, Lot Number: 131592; Medline Kit Number/SKU 60080349: UDI/DI ea …

What the firm is doing

Medline Industries, LP issued an URGENT MEDICAL DEVICE notice to its consignees on 3/24/2026 via email and mail. The notice explained the issue, potential risk and requested the following: "REQUIRED ACTION: 1. Immediately check your stock for the affected item number(s) and the affected lot number(s) listed within the recall portal. Quarantine all affected product. Upon completion of the below actions, please destroy affected product. 2. Please use the link and the information below to complete your response form. Please list the quantity of affected product you have in inventory on the form. Even if you do not have any affected product in inventory, please complete and submit the response form. Website link: https://recalls.medline.com Recall Reference #: R-26-046 Recall Code: 3. Upon receipt of your submitted response form, your account will receive over-labels to place on affected inventory, with instructions for your staff to remove and discard the affected component prior to using the kit. These labels will be provided via FedEx overnight, if applicable. 4. If you are a distributor or have resold or transferred this product to another company or individual, you are required by FDA regulations to notify them of this recall communication. Please include your customers quantities on your response form. Upon receipt of your submitted response form, you will receive over-labels to provide to your customers to affix to their affected product." For questions, contact the Recall Department at 866-359-1704 or recalls@medline.com.

DistributionShow details

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

Class IWhat this means

A reasonable probability that use of the product will cause serious adverse health consequences or death.

Sources & references

Source: U.S. FDA openFDA device enforcement reports. This summary is informational and may lag or differ from the official record. Always verify against the FDA before acting.

Taylor Coteus

Legal News Analyst

Taylor Coteus is RecallWatch's Legal News Analyst, covering FDA medical-device enforcement and patient-safety litigation. He reviews every recall against the FDA's official openFDA record before it is published and is responsible for corrections and editorial accuracy.

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