Medline Industries recalled 31,848 dialysis dressing change kits on January 8, 2026. The recall follows reports of defective silicone seals on Tego Connectors that may occlude fluid paths. This defect can delay therapy and expose patients to biological contaminants.
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.
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
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The recall includes several models of dialysis dressing change kits, specifically SKU EBSI1498, EBSI1107, EBSI1596, EBSI1781, EBSI1812, DT22630, EBSI1470, and DT22845. These kits were distributed nationwide in the U.S. and sold at multiple retailers.
Defective silicone seals on Tego Connectors may dome or tear, leading to occluded fluid paths. This defect can prevent users from injecting or withdrawing blood products, potentially delaying treatment and exposing patients to harmful biological contaminants.
There are no specific reports of injuries or deaths associated with this recall. However, the potential for serious health risks exists if fluid pathways are compromised.
Patients and healthcare providers should stop using the affected products immediately. Contact Medline Industries or your healthcare provider for further instructions and follow the recall instructions provided.
For more details, contact Medline Industries at [insert phone number]. Visit the FDA's website for further information: https://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Product-Tabs.cfm?recall_number=Z-1467-2026.
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