Z-1464-2026Class II

Medline Kits containing Tego Connectors Medline DIALYSIS ON/OFF KIT SKU EBSI1746

Name: Z-1464-2026 Medline Kits containing Tego Connectors Medline DIALYSIS ON/OFF KIT SKU EBSI1746
Creator: Medline Industries, LP
Published: 2026-01-08
License: https://open.fda.gov/license/

MEDLINE INDUSTRIES, LP - Northfield / initiated 2026-01-08 / Open, Classified / root cause: manufacturing process

FDA source

Medline Industries, LP began a recall of Medline Kits containing Tego Connectors Medline DIALYSIS ON/OFF KIT SKU EBSI1746 on 2026-01-08. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1464-2026
Classification: Class II
Status: Open, Classified
Initiated: 2026-01-08
Posted: 2026-02-24
Recalling firm: MEDLINE INDUSTRIES, LP - Northfield
Product: Medline Kits containing Tego Connectors Medline DIALYSIS ON/OFF KIT SKU EBSI1746
Product code: FKG Tray, Start/Stop (Including Contents), Dialysis
Reason for recall: 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.
Root cause tag: manufacturing process
FDA root cause: Process control
Action: 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.
Quantity in commerce: 2020
Distribution: US Nationwide distribution.
Product codes and lots: UDI-DI (ea) 10653160373582 UDI-DI (case) 00653160373585 Kit lots 2024051380 2024052080 2024052180 2024052280 2024071580 2025061790 2025072990

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1464-2026
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1463-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-03-04	2026-02-24
Z-1464-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-03-04	2026-02-24
Z-1465-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-03-04	2026-02-24
Z-1466-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-03-04	2026-02-24
Z-1467-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-03-04	2026-02-24
Z-1468-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-03-04	2026-02-24

Product code FKG

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)