HIGH

Medline Dialysis Kits Recalled Over Silicone Seal Issues

Medline Industries recalled 14,525 dialysis convenience kits on January 8, 2026. The recall affects multiple product SKUs due to potential silicone seal failures. These issues may cause therapy delays or exposure to contaminants.

Quick Facts at a Glance

Recall Date
January 8, 2026
Hazard Level
HIGH
Brand
Medline Industries, LP
Category
Health & Personal Care
Sold At
Multiple Retailers
Geographic Scope
1 states
At-Risk Groups
GENERAL

Hazard Information

Affected lots may exhibit issues with the silicone seal on Tego Connectors included in kits. Issues include silicone seal doming and silicone seal tearing. These issues may result in an occluded fluid path identified by the inability of the user to inject or withdraw blood product with a syringe. Damaged seals may also result in delay in therapy or fluid leakage, interruption in therapy, exposure to biological contaminants or air infused into the body.

What You Should Do

Patients and healthcare providers should stop using this device immediately. Follow the recall instructions provided by the manufacturer. Contact Medline Industries, LP or your healthcare provider for instructions. Notification method: Letter

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Product Details

The recall includes Medline ADD A CATH DIALYSIS KIT SKU ECVC8415A, Centurion CENTRAL LINE INSERTION TRAY SKU DT19810, and several other dialysis kits. These kits were distributed nationwide in the U.S.

The Hazard

Affected kits may have silicone seal defects, including doming and tearing. These defects can lead to an occluded fluid path, preventing the withdrawal or injection of blood products.

What to Do

Stop using these kits immediately and follow the recall instructions provided by Medline Industries. Contact your healthcare provider for further guidance.

Contact Information

For more information, contact Medline Industries at 1-800-633-5463 or visit their website for updates.

Key Facts

  • 14,525 units recalled
  • Recall date: January 8, 2026
  • Potential exposure to biological contaminants
  • Stop using immediately
  • Contact Medline for instructions

Safety Guide

Not sure what to do next? Our guide walks you through the process step by step.

Read: What to Do When You Find a Recalled Product

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Safety Assessment

Risk LevelHIGH
Severity Score
8/ 10
Affected Groups
GENERAL
Injury Types
OTHER

Product Details

Model Numbers
Medline ADD A CATH DIALYSIS KIT SKU ECVC8415A UDI-DI (ea) 10653160383628 UDI-DI (case) 00653160383621 Kit lots 2024121390 2025033190 Centurion CENTRAL LINE INSERTION TRAY SKU DT19810 UDI-DI (ea) 10653160368755 UDI-DI (case) 00653160368758 Kit lot 2025041090 Centurion DIALYSIS BUNDLE WITH NO CATHETTER SKU CVI4310A UDI-DI (ea) 10653160374978 UDI-DI (case) 00653160374971 Kit lots 2024051490 2025021290 2025051390 2025091090 Medline DIALYSIS CAP CHANGE KIT SKU DYNDC2425 UDI-DI (ea) 10653160375845 UDI-DI (case) 00653160375848 Kit lots 2024060690 2024101690 2024103190 2025010890 2025040190 Medline DIALYSIS CHANGE KIT SKU EBSI1453A UDI-DI (ea) 10653160383475 UDI-DI (case) 00653160383478 Kit lots 2024050790 2024051390 2024082290 2024111990 2025013090 2025032090 2025050190 2025062790 Centurion HEMODIALYSIS ACCESS KIT SKU DT12970 UDI-DI (ea) 10653160368922 UDI-DI (case) 00653160368925 Kit lots 2025040401 2025081401 Medline LARGE BORE
DIALYSIS
ENHANCED SECUREMENT SKU EBSI1741 UDI-DI (ea) 10653160374527 UDI-DI (case) 00653160374520 Kit lots 2024061780 2024070180 2024081280 2024111290 2025012490 2025032690 2025051390 2025061790 2025071490 2025072190
Affected States
ALL
Report Date
March 4, 2026
Recall Status
ACTIVE

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