Medline Dialysis Kits Recalled Over Tego Connector Seal Defects
Medline Industries is recalling dialysis dressing change kits containing Tego Connectors due to potential silicone seal doming or tearing that may block fluid flow during use.
What this means for you
Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: FDA Class II recall with potential for serious harm including therapy delay, fluid leakage, biological contaminant exposure, and air infusion, meeting the rubric criterion for FDA Class II with risk-of-harm products.
Plain-English summary
Medline Industries, LP is recalling convenience kits containing Tego Connectors used in dialysis dressing change procedures. The affected products include Medline DIALYSIS DRESSING CHANGE kits (SKUs EBSI1498, EBSI1107, EBSI1596, EBSI1781, EBSI1812, EBSI1470) and Centurion DIALYSIS/PHERESIS and VASCATH kits (SKUs DT22630, DT22845). A total of 31,848 units are included in the recall, which covers specific kit lots manufactured between May 2024 and August 2025.
The recall is being issued because the silicone seals on the Tego Connectors included in these kits may exhibit doming or tearing. These defects can result in an occluded fluid path, meaning users may be unable to inject or withdraw blood products using a syringe. Damaged seals may also cause delays in therapy, fluid leakage, interruption of treatment, exposure to biological contaminants, or air being infused into the body.
The products were distributed nationwide in the United States. Healthcare facilities and providers that use these dialysis kits should immediately check their inventory against the affected lot numbers listed in the recall notice and remove any affected units from use. Customers should contact Medline Industries, LP for replacement products or further instructions. No illnesses or injuries have been reported in connection with this recall at this time.
Consumers or healthcare providers with questions should contact Medline Industries, LP directly. The FDA has classified this recall as Class II, indicating that use of or exposure to the product may cause temporary or medically reversible adverse health consequences.
The recalled product
- Product
- Convenience kits containing Tego Connectors: Medline DIALYSIS DRESSING CHANGE SKU EBSI1498 Medline DIALYSIS DRESSING CHANGE KIT SKU EBSI1107 EBSI1596 EBSI1781 EBSI1812 Centurion DIALYSIS/PHERESUS CVC DRSG CHANGE KIT SKU DT22630 Medline DIALYSIS/PHERESIS DRESSING
- Manufacturer
- Medline Industries, LP
- Affected units
- 31,848
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 6 recalled by Medline Industries, LP under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 6 products in this recall →Related recalls
Same manufacturer · Medline Industries, LP
See all →- HighMedline IVS Blood Culture Kits Recalled for Sterility Breach
FDA (Devices) · 2026-09-09
- HighMedline Blood Culture Kits Recalled Due to Potential Seal Defects
FDA (Devices) · 2026-09-09
- HighMedline Convenience Kits Recalled for Potential Sterility Breach
FDA (Devices) · 2026-09-09
- SevereMedline Eye and Cataract Kits Recalled for Potential Sterility Breach
FDA (Devices) · 2026-09-09
- SevereMedline Ultrasound Breast Pack Recalled for Potential Sterility Breach
FDA (Devices) · 2026-09-09
Same hazard · fluid leakage
See all →- HighHalyard STANDARD LINE INSERTION PACK Recall for Silicone Seal Defect
FDA (Devices) · 2026-07-29
- SevereAbiomed Impella Introducer Kit recalled for potential fluid leakage
FDA (Devices) · 2026-07-22
- SevereABIOMED Insertion Kit heart pump accessories introducer sheath leakage
FDA (Devices) · 2026-07-22
- HighMedline Kits with Tego Connectors Recalled Due to Silicone Seal Defects
FDA (Devices) · 2026-03-04
- HighBlood Pump Recalled for Potential Fluid Leakage During Clinical Use
FDA (Devices) · 2025-03-19