Medline Industries Recalls Medical Kits Containing Tego Connectors Due to Seal Defects

FDA Recalls high FDA · · United States

Medline Industries, LP has issued a voluntary recall for 1,212 medical kits containing Tego Connectors due to silicone seal issues that may cause fluid path occlusion or air infusion.

What Happened

Medline Industries, LP has initiated a voluntary recall of specific medical kits containing Tego Connectors. The recall was prompted by reports that affected lots may exhibit defects in the silicone seal, including seal doming and tearing. These defects can result in an occluded fluid path, making it impossible for healthcare providers to inject or withdraw blood products with a syringe.

Which Products Are Affected

The recall affects 1,212 units distributed nationwide across the United States. The following products and lot numbers are included:

  • Medline APHERESIS SUBQPORT ACCESS KIT (SKU DYNDA2705)

    • UDI-DI (ea): 10193489468632
    • UDI-DI (case): 40193489468633
    • Affected Lots: 24DBL787, 24HBR630, 25ABH699, 25DBV209, 25GBQ405
  • Medline CENTRAL LINE INSERTION (SKU DYNJ63347A)

    • UDI-DI (ea): 10193489278064
    • UDI-DI (case): 40193489278065
    • Affected Lots: 24AMC874, 24AME139, 24AMH820, 24BMF097, 24CMF691, 24GMB769, 24GMK036, 24IMC124, 24LMA110, 25AMJ634, 25GMD386, 25IMB510, 25JMI708

What You Should Do

Medline Industries notified affected customers via a formal letter initiated on January 8, 2026. Healthcare facilities and distributors should immediately check their inventory for the SKU and lot numbers listed above. If affected products are found, users should follow the instructions provided in the firm’s notification letter regarding the return or disposal of the kits.

Why This Matters

Damaged or defective seals on these connectors can lead to significant clinical complications, including delays in therapy, fluid leakage, or the interruption of treatment. More critically, the defect poses a risk of exposure to biological contaminants or the infusion of air into a patient’s body.

Source

This information is based on official recall data from the FDA. Recall Number: Z-1466-2026.

Source: FDA Official Notice

Frequently Asked Questions

What is this fda recalls alert about?
Medline Industries, LP has issued a voluntary recall for 1,212 medical kits containing Tego Connectors due to silicone seal issues that may cause fluid path occlusion or air infusion.
Which agency issued this alert?
This alert was issued by FDA. The original notice is available at the source link at the bottom of this article.
How severe is this alert?
This alert is classified as "high" severity. Take precautions and monitor for updates.
What area is affected?
This alert affects United States. Check with FDA for the most current geographic scope.
Where can I find more fda recalls alerts?
Browse all fda recalls alerts on Areazine at areazine.com/recalls/fda/ for the latest updates from FDA and other agencies.