Recall archive / FDA device enforcement
1. 3 VALVE MAN KIT, Medline Kit SKU Number: 65101544; 2. 3V MANIFOLD KIT, Medline Kit SKU Number: 65110351; 3. HEART ... — FDA record Z-2145-2026
Reported ongoing
Status as reported in the agency record. FDA warns that enforcement status may not track the current recall lifecycle; check the current official notice.
Source date Mar 24, 2026. Retrieved Oct 1, 2026. Last updated Oct 1, 2026.
Archive changed Oct 1, 2026. USDA FSIS records are unavailable; check FSIS directly. Source coverage and dates.
What the record says
- Product
- 1. 3 VALVE MAN KIT, Medline Kit SKU Number: 65101544; 2. 3V MANIFOLD KIT, Medline Kit SKU Number: 65110351; 3. HEART CATH PACK-LF, Medline Kit SKU Number: DYNJ0373285M; 4. ANGIO DRAPE CARDIAC PACK, Medline Kit SKU Number: DYNJ51615P; 5. ANGIO DRAPE CARDIAC PACK, Medline Kit SKU Number: DYNJ51615R; 6. HEART RADIAL LAB PACK, Medline Kit SKU Number: DYNJ61982C; 7. HEART RADIAL LAB PACK, Medline Kit SKU Number: DYNJ61982D; 8. HEART ABLATION DRAPE PACK, Medline Kit SKU Number: DYNJ61984C; 9. TAVR PACK, Medline Kit SKU Number: DYNJ62310B; 10. HEART TAVR PACK, Medline Kit SKU Number: DYNJ65174G; 11. FEMORAL CARDIAC CATH, Medline Kit SKU Number: DYNJ66343A; 12. CARDIAC CATH PACK, Medline Kit SKU Number: DYNJ66693C; 13. TAVR PACK, Medline Kit SKU Number: DYNJ67225C; 14. AFIB TRAY, Medline Kit SKU Number: DYNJ85069; 15. AFIB TRAY, Medline Kit SKU Number: DYNJ85069A; 16. AFIB TRAY, Medline Kit SKU Number: DYNJ85069B; 17. MTO,LEFT HEART,KIT, Medline Kit SKU Number: VASC1811. Namic medical convenience kits, containing Namic Manifold, Labeled as: 1. DBD-MTS,3V,MAN,KIT, Medline Kit Number/SKU 60010195; 2. MTS,4 VALVE,LFT,HRT,KIT, Medline Kit Number/SKU 60010468; 3. MTO,ADD,ON,KIT, Medline Kit Number/SKU 60010469; 4. MTS,RT,HANDED/LFT,HRT,KIT, Medline Kit Number/SKU 60010508; 5. MTS,LFT,HRT,KIT, Medline Kit Number/SKU 60012911; 6. MTO,RIGHT HEART,KIT, Medline Kit Number/SKU 60012912; 7. DBD-MTS,LEFT HEART,KIT, Medline Kit Number/SKU 60013001; 8. MTS,LEFT HEART,KIT, Medline Kit Number/SKU 60013101; 9. MTS,LFT,HRT,W/WIRE, Medline Kit Number/SKU 60013112; 10. MTS,-,3V,KIT, Medline Kit Number/SKU 60020608; 11. MTO,ANGIO,KIT, Medline Kit Number/SKU 60032681; 12. MTS-LEFT HEART,KIT, Medline Kit Number/SKU 60033123; 13. MTS,RIGHT HEART,KIT, Medline Kit Number/SKU 60033124; 14. MTO,LEFT HEART,KIT, Medline Kit Number/SKU 60034644; 15. MTS,LEFT HEART,KIT, Medline Kit Number/SKU 60040273; 16. MTO,2V,LEFT HEART,KIT, Medline Kit Number/SKU 60040424; 17. MTS,3,VAVLE,KIT, Medline Kit Number/SKU 60041082; 18. MTS,2V,KIT, Medline Kit Number/SKU 60042453; 19. MTO,3V,KIT, Medline Kit Number/SKU 60042454; 20. MTS,LEFT HEART,KIT, Medline Kit Number/SKU 60042721; 21. MTS,3 VALVE,KIT, Medline Kit Number/SKU 60050183; 22. MTS,3 VALVE,MANIFOLD,KIT, Medline Kit Number/SKU 60060268; 23. MTO,RT,HRT,KIT, Medline Kit Number/SKU 60060564; 24. MTO,LEFT HEART,KIT, Medline Kit Number/SKU 60060569; 25. MTS, Medline Kit Number/SKU 60062021; 26. MTS,LEFT HEART,KIT, Medline Kit Number/SKU 60071232; 27. MTO,CATH,LAB,KIT, Medline Kit Number/SKU 60080221; 28. MTO,RIGHT, Medline Kit Number/SKU 60080347; 29. MTS,LEFT HEART,KIT, Medline Kit Number/SKU 60080349; 30. MTS,MANIFOLD,KIT, Medline Kit Number/SKU 60080716; 31. MTS,LEFT,HRT,KIT, Medline Kit Number/SKU 60081001; 32. MTS,RIGHT HEART,KIT, Medline Kit Number/SKU 60081002; 33. MTO,LEFT,HRT(RT,HANDED), Medline Kit Number/SKU 60081168; 34. MTO,RIGHT HEART,KIT, Medline Kit Number/SKU 60090123; 35. MTS,LEFT HEART,KIT, Medline Kit Number/SKU 60091111; 36...
- Reason
- Medline has identified the presence of particulate within the fluid path of the Manifolds.
- Classification
- Class I
- Recalling firm
- Medline Industries, LP
- Quantity
- 567675 kits
- Agency-reported status
- Ongoing
- Source record identifier
- Z-2145-2026
What the recall classes mean. Classification is an agency assessment, not individual medical advice.
Lot and product identifiers
| Label field | Details supplied by the agency |
|---|---|
| Lot, code or applicability | 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 600... |
The agency lot list is longer than this excerpt. Read the complete list at the official source.
Match all identifying details in the current notice. A brand name alone is not enough.
Distribution
US (nationwide) and AE, AU, CA, JP, KR, NL, SG, SK.
States below are derived from the distribution text, including nationwide wording. They are not inferred from the firm's address.
- Alaska
- Alabama
- Arkansas
- Arizona
- California
- Colorado
- Connecticut
- Delaware
- Florida
- Georgia
- Hawaii
- Iowa
- Idaho
- Illinois
- Indiana
- Kansas
- Kentucky
- Louisiana
- Massachusetts
- Maryland
- Maine
- Michigan
- Minnesota
- Missouri
- Mississippi
- Montana
- North Carolina
- North Dakota
- Nebraska
- New Hampshire
- New Jersey
- New Mexico
- Nevada
- New York
- Ohio
- Oklahoma
- Oregon
- Pennsylvania
- Rhode Island
- South Carolina
- South Dakota
- Tennessee
- Texas
- Utah
- Virginia
- Vermont
- Washington
- Wisconsin
- West Virginia
- Wyoming
Dates in the source
- Report date
- May 20, 2026
- Recall initiation date
- Mar 24, 2026
- Center classification date
- May 8, 2026
FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable.