Medline Industries Recalls Dialysis On/Off Kits Due to Tego Connector Seal Issues
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Medline Industries, LP has issued a voluntary recall for 2,020 Dialysis On/Off Kits containing Tego Connectors due to defective silicone seals that may cause therapy interruptions or contamination.
What this FDA recall tells you, and what most readers miss
This notice was issued by FDA on April 6, 2026 and geographically references United States. Its severity classification of "high" signals how the issuing agency weighs the risk of harm if no action is taken - "critical" and "high" tier alerts typically carry direct consumer actions, while "medium" and "low" tend toward informational guidance or monitoring advisories. The category it belongs to - FDA Recalls - determines the consumer-protection framework behind it, which shapes what remedies (refunds, replacements, repairs, or the recall itself) are available to affected consumers and which agency holds statutory responsibility for enforcement.
Most readers skim a notice like this, check whether they are personally affected, and move on. The more useful lens is to verify its scope, source, and timestamp, then compare related notices without assuming that one record proves a broader trend.
Areazine pairs this record with the original agency URL so you can check the primary source before acting. Its related labels are recall, product-safety, fda, medical-device.
What Happened
Medline Industries, LP has initiated a voluntary recall of specific dialysis kits following reports of issues with the silicone seals on Tego Connectors included in the kits. The affected seals may exhibit "doming" or tearing. These defects can result in an occluded fluid path, preventing users from injecting or withdrawing blood products. Additionally, damaged seals may lead to fluid leakage, therapy delays or interruptions, exposure to biological contaminants, or the infusion of air into the patient's body.
Which Products Are Affected
The recall involves the Medline DIALYSIS ON/OFF KIT (SKU EBSI1746) containing Tego Connectors. A total of 2,020 units are affected by this recall.
Identification Details:
- UDI-DI (ea): 10653160373582
- UDI-DI (case): 00653160373585
- Affected Kit Lots: 2024051380, 2024052080, 2024052180, 2024052280, 2024071580, 2025061790, 2025072990
These products were distributed nationwide across the United States.
What You Should Do
Medline Industries, LP notified customers of the issue via a formal letter initiated on January 8, 2026. Healthcare providers and facilities should immediately check their inventory for the affected lot numbers listed above. If affected products are found, users should follow the specific instructions provided in the firm's notification letter regarding the return or disposal of the kits.
Why This Matters
This recall is significant because defective seals in dialysis equipment can lead to serious medical complications, including the inability to perform necessary blood transfers, potential exposure to contaminants, or the life-threatening risk of air being infused into the body during treatment.
Source
Information provided by the FDA under Recall Number Z-1464-2026.
Original source: FDA Official Notice ↗
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