Class I U.S. Food and Drug Administration

1. DBD-MTS,3V,MAN,KIT, Medline Kit Number/SKU 60010195 recall: Medline has identified the presence of particulate within the fluid path

Recall published 5 months ago

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

The hazard: Device safety concern

This is a device enforcement record. Check whether the remedy is a correction, a software update or a removal before changing anything.

What the notice says: Medline has identified the presence of particulate within the fluid path of the Manifolds.

Why it matters: The FDA recorded an enforcement action against this device. Most device recalls are corrections rather than removals, so the device often stays in use while the manufacturer issues a fix.

Recall details

Recall number
Z-2144-2026
Published
May 20, 2026
Risk level
Class I
Status
Ongoing
Issued by
U.S. Food and Drug Administration
Brand
Medline Industries, LP
Product type
Medical devices
Units affected
322460 kits
Distribution
Nationwide
Made in
United States
Lot / code info
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; Med…
UPC codes
10193489040234, 40193489040235, 10193489042436, 40193489042437, 10193489043273, 40193489043274, 10193489044539, 40193489044530, 10193489045062, 40193489045063

Products covered by this recall

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

Check your product

The notice names 50 codes you can read straight off the package. Type the one printed on yours and the list below narrows to it.

UPC / barcode

Read the twelve digits under the barcode on the package.

  • 10193489040234
  • 40193489040235
  • 10193489042436
  • 40193489042437
  • 10193489043273
  • 40193489043274
  • 10193489044539
  • 40193489044530
  • 10193489045062
  • 40193489045063

Lot or batch code

Usually ink-stamped near the seam, the cap or the bottom of the pack.

  • 24CBF820
  • 24DBR149
  • 24HBO437
  • 24IBJ827
  • 25ABI082
  • 25BBI613
  • 25BBR862
  • 25DBC934
  • 25DBT579
  • 25FBF145
  • 25GBJ123
  • 25HBQ032
  • 25IBF219
  • 25JBS750
  • 25LBD357
  • 25ABW077
  • 25CBO600
  • 25DBR987
  • 25FBH978
  • 25IBF270

Model or item number

On the rating label, the box or the instruction sheet.

  • 60010195
  • 60033123
  • 60050183
  • 60080349
  • 60100338
  • 60101017
  • 60130506
  • 60131324
  • 60132238
  • 60138301
  • 60140589
  • 60192012
  • 60220488
  • 60232091
  • 65010037
  • 65012819
  • 65040421
  • 65183482
  • 65660872
  • 601006269

Codes are lifted verbatim from the FDA — Device enforcement notice. A code that is missing here may still be covered — the official notice is the complete list.

What to do about Device

Medline Industries, LP — This is a device enforcement record. Check whether the remedy is a correction, a software update or a removal before changing anything.

  1. Match the model, catalogue, lot and serial numbers on your device against the identifiers on this page.
  2. If you are a facility, quarantine affected stock and log the correction.
  3. Report device problems to the FDA through MedWatch.
  4. If the device is implanted or you depend on it daily, speak to your clinician before changing how you use it.

Replacements, repairs and reimbursement

Device remedies run through the supply chain, so the route depends on who sold you the unit.

  • Contact the distributor or clinic named on your paperwork and quote the recall number on this page. They will tell you whether the remedy is a repair, a replacement or an instruction update.
  • If the device was billed to insurance or Medicare, the replacement is usually billed the same way; you should not face a second deductible for a recall.
  • Keep every piece of correspondence. If a recalled device caused harm, that paper trail is what a claim rests on.
  • Consumer-purchased devices such as monitors and test kits are normally replaced free, with return shipping paid.

Company contact: Medline Industries, LP — 3 Lakes Dr, Northfield, IL, 60093-2753

The official notice

This page summarises a notice published by U.S. Food and Drug Administration. The agency notice is the authoritative version — read it before you act, and treat it as the final word if anything here looks different.

Open the FDA — Device enforcement record U.S. Food and Drug Administration recalls

Questions people ask about this recall

Why was Medline Industries, LP medical devices recalled?

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

How do I know if I have the recalled product?

Match the codes printed on your package against the notice: UPC 10193489040234, 40193489040235, 10193489042436; lot code 24CBF820, 24DBR149, 24HBO437; model number 60010195, 60033123, 60050183. If the code on your package is not on that list, your unit is outside the recall.

What should I do with it right now?

Match the model, catalogue, lot and serial numbers on your device against the identifiers on this page.

Can I get my money back?

Contact the distributor or clinic named on your paperwork and quote the recall number on this page. They will tell you whether the remedy is a repair, a replacement or an instruction update.

Where was the recalled product sold?

It was distributed nationwide.

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