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RecallWatchMedical Device Safety
Class IIOngoingZ-1465-2026

Medline Industries, LP recalls Convenience kits used for dialysis maintenance Medline ADD A CATH DIALYSIS KIT SKU…

Medline Industries, LPNorthfield, IL, United StatesReported Mar 4, 2026 · 4 months ago
Legal News Analyst ·

Reason for recall

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.

Affected product

Check your device

Enter a lot, serial, REF, or UDI number from your device's label to check it against this recall's listed codes.

Affected products & lots

  • 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 SKUEBSI1741
    50 affected lots
    20241213902025033190DT1981010653160368755006531603687582025041090CVI4310A10653160374978
    +42 more006531603749712024051490202502129020250513902025091090DYNDC2425106531603758450065316037584820240606902024101690202410319020250108902025040190EBSI1453A106531603834750065316038347820240507902024051390202408229020241119902025013090202503209020250501902025062790DT12970106531603689220065316036892520250404012025081401EBSI174110653160374527006531603745202024061780202407018020240812802024111290202501249020250326902025051390202506179020250714902025072190

What the firm is doing

On January 8, 2026, the firm notified affected customers of the product issue through email and first class mail. Customers were instructed to request stickers to over-label affected convenience kits with a warning label indicating to remove the affected component and replace it with product from supply. No kits are to returned.

DistributionShow details

US Nationwide distribution.

Class IIWhat this means

Use of the product may cause temporary or medically reversible adverse health consequences.

Sources & references

Source: U.S. FDA openFDA device enforcement reports. This summary is informational and may lag or differ from the official record. Always verify against the FDA before acting.

Taylor Coteus
Legal News Analyst

Taylor Coteus is RecallWatch's Legal News Analyst, covering FDA medical-device enforcement and patient-safety litigation. He reviews every recall against the FDA's official openFDA record before it is published and is responsible for corrections and editorial accuracy.

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