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Open, Classified

Convenience kits containing Tego Connectors Medline DIALYSIS DRSNG CHNG SKU DYNDC3167

FDA Recall Z-1468-2026 · Posted 2026-02-24

Recall StatusOpen, Classified
Product CodeOXQ
Date Initiated2026-01-08
Product Quantity150

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.

Firm Action

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.

Root Cause

Process control

Distribution Pattern

US Nationwide distribution.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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