HIGHFDA DEVICE

Medline Dialysis Kits Recalled Over Silicone Seal Issues

Official notice
Medline Industries, LPHealth & Personal CareMedical DevicesMedline 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 BOREDIALYSISENHANCED SECUREMENT SKU EBSI1741 UDI-DI (ea) 10653160374527 UDI-DI (case) 00653160374520 Kit lots 2024061780 2024070180 2024081280 2024111290 2025012490 2025032690 2025051390 2025061790 2025071490 2025072190

Source-backed recall notice

No product image was available from the source feed.

Official source
FDA DEVICE
Recall date
January 8, 2026
Status
ACTIVE
Severity
8/10

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

What to Do Now

Use this page like a recall checklist: verify the product first, then act on the official remedy.

Immediate steps

  1. 1Stop using the product until you confirm whether it is included in the recall.
  2. 2Compare the product label, model number, UPC, color, size, and purchase location against the identifiers below.
  3. 3Follow the official remedy from FDA - Medical Devices; save photos, receipts, labels, and correspondence before contacting the company.
  4. 4If the product could harm a child, older adult, pet, or patient, move it out of reach immediately.

Check these identifiers

Brand
Medline Industries, LP
Product type
Dialysis Kits
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
Sold at
Multiple Retailers
Where affected
ALL

Recall Timeline

Key dates and source checks for this recall record.

  1. Recall announced

    January 8, 2026

  2. Reported by FDA DEVICE

    March 4, 2026

  3. RecallRadar source check

    March 11, 2026

  4. Consumer action

    Use the official remedy and keep documentation.

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

About This Product

These dialysis kits are used in medical settings for maintaining dialysis therapy. They are essential for patients undergoing hemodialysis and require reliable performance to ensure safety during treatment.

Industry Context

This recall is not part of a broader industry pattern.

Real-World Impact

Patients and healthcare providers must stop using the affected kits immediately, which may cause interruptions in therapy and require sourcing alternative supplies.

Practical Guidance

How to identify if yours is affected

  1. Locate the SKU and lot number on the product packaging.
  2. Compare your kit's SKU and lot numbers with the recall notice.
  3. If they match, stop using the product immediately.

Where to find product info

The SKU and lot numbers can typically be found on the box or packaging of the dialysis kit.

What timeline to expect

Expect a refund or replacement process to take approximately 4-6 weeks after product return.

If the manufacturer is unresponsive

  • Document all communication attempts with Medline.
  • Consider reaching out to your healthcare provider for assistance.

How to prevent similar issues

  • Always check for recalls before using medical devices.
  • Ensure that devices have current safety certifications.
  • Consult healthcare professionals for alternative products when in doubt.

Documentation advice

Keep records of your communication with the manufacturer, receipts of purchase, and any documentation related to the recall.

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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.

Key Facts

  • Recall date: January 8, 2026
  • 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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