Z-1466-2026Class II

Medline kits containing Tego Connectors Medline APHERESIS SUBQPORT ACCESS KIT SKU DYNDA2705 Medline CENTRAL...

Name: Z-1466-2026 Medline kits containing Tego Connectors Medline APHERESIS SUBQPORT ACCESS KIT SKU DYNDA2705 Medline CENTRAL...
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 APHERESIS SUBQPORT ACCESS KIT SKU DYNDA2705 Medline CENTRAL LINE INSERTION SKU DYNJ63347A 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-1466-2026
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 APHERESIS SUBQPORT ACCESS KIT SKU DYNDA2705 Medline CENTRAL LINE INSERTION SKU DYNJ63347A
Product code: LRO General Surgery 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: 1212
Distribution: US Nationwide distribution.
Product codes and lots: SKU DYNDA2705 UDI-DI (ea) 10193489468632 UDI-DI (case) 40193489468633 Kit lots 24DBL787 24HBR630 25ABH699 25DBV209 25GBQ405 SKU DYNJ63347A UDI-DI (ea) 10193489278064 UDI-DI (case) 40193489278065 Kit lots 24AMC874 24AME139 24AMH820 24BMF097 24CMF691 24GMB769 24GMK036 24IMC124 24LMA110 25AMJ634 25GMD386 25IMB510 25JMI708

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1466-2026
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 LRO

K213481Class IIMedline General Surgery TrayMedline Industries, Inc. / cleared 2022-05-24

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)