Z-1467-2026Class II

Convenience kits containing Tego Connectors: Medline DIALYSIS DRESSING CHANGE SKU EBSI1498 Medline DIALYSIS...

Name: Z-1467-2026 Convenience kits containing Tego Connectors: Medline DIALYSIS DRESSING CHANGE SKU EBSI1498 Medline DIALYSIS...
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 Convenience kits containing Tego Connectors: Medline DIALYSIS DRESSING CHANGE SKU EBSI1498 Medline DIALYSIS DRESSING CHANGE KIT SKU EBSI1107 EBSI1596 EBSI1781... 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-1467-2026
Classification: Class II
Status: Open, Classified
Initiated: 2026-01-08
Posted: 2026-02-24
Recalling firm: MEDLINE INDUSTRIES, LP - Northfield
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 CHANGE KIT SKU EBSI1470 Centurion VASCATH DRESSING CHANGE TRAY SKU DT22845
Product code: OXQ Dressing Change Tray
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: 31,848
Distribution: US Nationwide distribution.
Product codes and lots: Medline DIALYSIS DRESSING CHANGE SKU EBSI1498 UDI-DI (ea) 10193489111538 UDI-DI (case) 20193489111535 Kit lots 2024052090 2024072690 2024100390 2024121290 2025020490 2025041590 2025062790 2025090890 Medline DIALYSIS DRESSING CHANGE KIT SKU EBSI1107 UDI-DI (ea) 10889942723508 UDI-DI (case) 40889942723509 Kit lots 2024051690 2024073190 2024092490 2024121190 2025020790 2025032790 2025052990 EBSI1596 UDI-DI (ea) 10653160357162 UDI-DI (case) 00653160357165 Kit lots 2024070190 2024082390 2024102390 2024121790 2025031090 2025040190 2025052790 2025072890 EBSI1781 UDI-DI (ea) 10653160379638 UDI-DI (case) 00653160379631 Kit lots 2024100490 2024123090 EBSI1812 UDI-DI (ea) 10653160386735 UDI-DI (case) 00653160386738 Kit lots 2025032190 2025052990 Centurion DIALYSIS/PHERESUS CVC DRSG CHANGE KIT SKU DT22630 UDI-DI (ea) 10653160345343 UDI-DI (case) 00653160345346 Kit lots 2024050680 2024072980 2024090380 2024111290 2024121190 2025032890 2025061790 2025072390 Medline DIALYSIS/PHERESIS DRESSING CHANGE KIT SKU EBSI1470 UDI-DI (ea) 10193489199307 UDI-DI (case) 20193489199304 Kit lots 2024052080 2024070880 2024110490 2025010290 2025022090 2025030390 2025040990 2025072990 Centurion VASCATH DRESSING CHANGE TRAY SKU DT22845 UDI-DI (ea) 10653160355151 UDI-DI (case) 00653160355154 Kit lots 2024060790 2024080790 2024100990 2024112590 2025042490 2025082090

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1467-2026
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 OXQ

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)