Medline dialysis dressing change kits recalled over connector seal defects
Medline is recalling convenience kits containing Tego Connectors, sold as the Medline Dialysis Dressing Change kit, because the silicone seal may dome or tear and occlude the fluid path.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: Rubric level 3 covers risk-of-harm products where injury has not yet been reported: this is an FDA Class II recall describing potential therapy interruption and contamination, with no hospitalisations stated in the source.
Plain-English summary
Medline Industries, LP is recalling convenience kits containing Tego Connectors, sold as the Medline Dialysis Dressing Change kit (SKU DYNDC3167). About 150 units were distributed nationwide in the United States. The FDA has classified this recall as Class II.
Affected lots may exhibit issues with the silicone seal on the Tego Connectors, including 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, fluid leakage, interruption in therapy, exposure to biological contaminants, or air infused into the body.
Affected product carries UDI-DI 10195327015954 (each) and 40195327015955 (case), in kit lots 24IME953 and 25CMA708.
Facilities can identify affected kits by the SKU, UDI and lot codes above, and may contact Medline Industries, LP for further information.
The recalled product
- Product
- Convenience kits containing Tego Connectors Medline DIALYSIS DRSNG CHNG SKU DYNDC3167
- Manufacturer
- Medline Industries, LP
- Category
- Medical Device — Dialysis kit
- Affected units
- 150
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 →- ModerateMedline surgical convenience kits recalled for non-conforming cannula components
FDA (Devices) · 2026-10-21
- ModerateMedline Recalls Surgical Convenience Kits with Non-Conforming Cannula Components
FDA (Devices) · 2026-10-21
- SevereMedline Recalls Surgical Convenience Kits with Non-Conforming Cannula Components
FDA (Devices) · 2026-10-21
- ModerateMedline Foot Ankle Convenience Kit Recalled for Shelf-Life Discrepancy
FDA (Devices) · 2026-10-21
- ModerateMedline recalls CONMED AirSeal Access Port kits due to pressure alerts
FDA (Devices) · 2026-10-21
Same hazard · seal failure
See all →- SevereReprocessed Electrophysiology Catheter with Incomplete Sterile Seals Recalled
FDA (Devices) · 2026-05-20
- HighMedline dialysis kits recalled over damaged Tego connector silicone seals
FDA (Devices) · 2026-03-04
- HighMedline dialysis maintenance kits recalled over Tego connector seal defects
FDA (Devices) · 2026-03-04
- HighMedline apheresis and central line kits recalled over connector seal defects
FDA (Devices) · 2026-03-04
- HighOxycodone blister cards recalled over seals that let tablets fall out
FDA (Drugs) · 2026-02-18
Similar recalls
- HighMedline Recalls Dialysis Convenience Kits Due to Syringe Quality Issues
FDA (Devices) · 2024-09-18
- HighMedline Convenience Kits Recalled Due to Defective Plastic Syringes
FDA (Devices) · 2024-09-18
- HighMedline Dialysis Pack Recalled Due to Potential Non-Sterile Product Risk
FDA (Devices) · 2024-10-30
- HighMedline Medical Convenience Kits with Defective Plastic Syringes Recalled
FDA (Devices) · 2024-09-18
- HighMedline Sterile Procedure Kits recalled for potential seal issues
FDA (Devices) · 2025-04-23
- HighMedline Convenience Kits Recalled Due to Weak Breather Pouch Seals
FDA (Devices) · 2025-04-23