Medline Industries Recalls IR Packs and Dialysis Insertion Kits Due to Faulty Tego Connectors

What Happened

Medline Industries, LP has initiated a voluntary Class II recall of specific medical kits containing Tego Connectors. The recall was prompted by reports that the silicone seals on these connectors may exhibit issues such as “doming” or tearing. These defects can result in an occluded fluid path, making it impossible for healthcare providers to inject or withdraw blood products using a syringe. Additionally, damaged seals may lead to fluid leakage, therapy interruptions, exposure to biological contaminants, or the infusion of air into a patient’s body.

Which Products Are Affected

The recall affects a total of 516 units distributed nationwide across the United States. The following products and lot numbers are included:

Medline IR Pack (SKU: DYNJ67205C)

• UDI-DI (ea): 10195327621780
• UDI-DI (case): 40195327621781
• Affected Lots: 24BBP627, 24DBO029, 24FBI148, 24JBA858, 24KBD925, 24LBG978, 25ABQ002, 25EBV162

Medline NO CATHETER DIALYSIS INSERTION (SKU: CVI5200)

• UDI-DI (ea): 10195327675219
• UDI-DI (case): 40195327675210
• Affected Lots: 24EBM915, 24GBC287

What You Should Do

Medline Industries, LP notified affected customers via letter starting on January 8, 2026. Healthcare facilities and distributors should immediately check their inventory for the SKU and lot numbers listed above. Affected products should be quarantined and handled according to the instructions provided in the firm’s notification letter. For questions regarding the return or replacement of these kits, contact Medline Industries, LP directly at their Northfield, IL headquarters.

Why This Matters

The failure of the silicone seal in these connectors poses a significant risk to patient safety, as it can lead to the infusion of air into the body or exposure to harmful biological contaminants during critical medical procedures.

Source

FDA Recall Notice Z-1463-2026