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Medline Apheresis and Dialysis Kits
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MEDICAL DEVICE RECALLMODERATE

Medline Apheresis and Dialysis Kits

Medline is recalling kits containing Tego Connectors due to potential silicone seal defects that may cause fluid leakage or therapy delays.

What to do

Immediately stop using the affected kits and contact Medline Industries, LP for further instructions regarding the return or disposal of the product.

Recalled
Listed
Updated
Recall No.
Z-1464-2026
Agency
FDA
Firm
Medline Industries, LP
Recall ID
98333
Status
ONGOING

Why it was recalled

Medline is recalling specific kits containing Tego Connectors due to potential silicone seal doming or tearing. These defects can cause fluid path occlusion, therapy delays, fluid leakage, or the risk of air infusion and biological contamination. The affected kits are distributed nationwide.

Is mine affected?

Check the model, lot, or serial number on the device or its packaging. Yours is affected if it matches one below.

ProductRecall #UDI-DI
Medline Kits containing Tego Connectors Medline DIALYSIS ON/OFF KIT SKU EBSI1746Z-1464-202610653160373582, 00653160373585, 2024051380, 2024052080, 2024052180, 2024052280, 2024071580, 2025061790, 2025072990
Convenience kits containing Tego Connectors Medline DIALYSIS DRSNG CHNG SKU DYNDC3167Z-1468-202610195327015954, 40195327015955
Convenience kits used for dialysis maintenance Medline ADD A CATH DIALYSIS KIT SKU ECVC8415A Centurion CENTRAL LINE INSERTION TRAY SKU DT19810 Centurion DIALYSIS BUNDLE WITH NO CATHETTER SKU CVI4310A Medline DIALYSIS CAP CHANGE KIT SKU DYNDC2425 Medline DIALYSIS CHANGE KIT SKU EBSI1453A Centurion HEMODIALYSIS ACCESS KIT SKU DT12970 Medline LARGE BORE, DIALYSIS, ENHANCED SECUREMENT SKU EBSI1741Z-1465-202610653160383628, 00653160383621, 2024121390, 2025033190, 10653160368755, 00653160368758, 2025041090, 10653160374978, 00653160374971, 2024051490, 2025021290, 2025051390, 2025091090, 10653160375845, 00653160375848, 2024060690, 2024101690, 2024103190, 2025010890, 2025040190
Medline kits containing Tego Connectors Medline APHERESIS SUBQPORT ACCESS KIT SKU DYNDA2705 Medline CENTRAL LINE INSERTION SKU DYNJ63347AZ-1466-202610193489468632, 40193489468633, 10193489278064, 40193489278065
Medline Kits containing Tego ConnectorsZ-1463-202610195327621780, 40195327621781, 10195327675219, 40195327675210
Convenience kits containing Tego ConnectorsZ-1467-202610193489111538, 20193489111535, 2024052090, 2024072690, 2024100390, 2024121290, 2025020490, 2025041590, 2025062790, 2025090890, 10889942723508, 40889942723509, 2024051690, 2024073190, 2024092490, 2024121190, 2025020790, 2025032790, 2025052990, 10653160357162

Where it was sold

Distributed nationwide.

Timeline

  1. Firm initiated recall
  2. Publicly announced
  3. Listed on Recall Canary
  4. Summary updated

Other recent recalls from Medline Industries, LP

All recalls from Medline Industries, LP

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Editorial summary by Recall Canary · summary updated 2026-07-06 · primary source: U.S. Food and Drug Administration · severity reflects the agency's published classification