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Medline kits containing Tego Connectors recallZ-1466-2026 · Medline Industries, LP · initiated Jan 8, 2026

Open, Classified

Is my device affected?

  1. 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.
  2. 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.
  3. 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-1466-2026
Status
Open, Classified
Initiated by the company
Jan 8, 2026
Posted by the FDA
Feb 24, 2026
Recalling firm
Medline Industries, LP
Quantity
1212
Product code
LRO
FDA submissions
K213481
Distribution
US Nationwide distribution.

Product description

Medline kits containing Tego Connectors Medline APHERESIS SUBQPORT ACCESS KIT SKU DYNDA2705 Medline CENTRAL LINE INSERTION SKU DYNJ63347A

Code information (models, lots, serial numbers)

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

Devices named in this recall

2 devices in the FDA device registry whose identifier appears in the recall's code information.

Other devices under the same FDA submission

321 devices cleared under K213481 are not named by identifier in this recall. One submission often covers many models, so they may or may not be affected.

Other products in the same recall event

The FDA groups related products into one recall event (event 98333).

Sources and updates

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