Medline Kits containing Tego Connectors recallZ-1464-2026 · Medline Industries, LP · initiated Jan 8, 2026
Open, Classified
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Medline Industries, LP or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
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.
FDA root cause category: Process control
What the company is doing
On January 8, 2026, the firm notified affected customers of the product issue through email and first class mail. Customers were instructed to request stickers to over-label affected convenience kits with a warning label indicating to remove the affected component and replace it with product from supply. No kits are to returned.
Recall details
- Recall number
- Z-1464-2026
- Status
- Open, Classified
- Initiated by the company
- Jan 8, 2026
- Posted by the FDA
- Feb 24, 2026
- Recalling firm
- Medline Industries, LP
- Quantity
- 2020
- Product code
- FKG
- Distribution
- US Nationwide distribution.
Product description
Medline Kits containing Tego Connectors Medline DIALYSIS ON/OFF KIT SKU EBSI1746
Code information (models, lots, serial numbers)
UDI-DI (ea) 10653160373582 UDI-DI (case) 00653160373585 Kit lots 2024051380 2024052080 2024052180 2024052280 2024071580 2025061790 2025072990
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- MEDLINE EBSI1746Medline Industries, Inc. · TRAY, START/STOP (INCLUDING CONTENTS), DIALYSIS1 recall0 reports
Other products in the same recall event
The FDA groups related products into one recall event (event 98333).
- Z-1463-2026 · Open, ClassifiedMedline Kits containing Tego Connectors: Medline IR Pack, SKU DYNJ67205C Medline NO CATHETER DIALYSIS INSERTION, SKU CVI5200
- Z-1465-2026 · Open, ClassifiedConvenience kits used for dialysis maintenance Medline ADD A CATH DIALYSIS KIT SKU ECVC8415A Centurion CENTRAL LINE INSERTION TRAY SKU DT19810 Centurion DIALYSIS BUNDLE WITH NO …
- Z-1466-2026 · Open, ClassifiedMedline kits containing Tego Connectors Medline APHERESIS SUBQPORT ACCESS KIT SKU DYNDA2705 Medline CENTRAL LINE INSERTION SKU DYNJ63347A
- Z-1467-2026 · Open, ClassifiedConvenience kits containing Tego Connectors: Medline DIALYSIS DRESSING CHANGE SKU EBSI1498 Medline DIALYSIS DRESSING CHANGE KIT SKU EBSI1107 EBSI1596 EBSI1781 EBSI1812 Centurion…
- Z-1468-2026 · Open, ClassifiedConvenience kits containing Tego Connectors Medline DIALYSIS DRSNG CHNG SKU DYNDC3167
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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