Medline Industries Recalls Medical Kits Containing Tego Connectors Due to Seal Defects
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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 this FDA recall tells you, and what most readers miss
This notice was issued by FDA on April 6, 2026 and geographically references United States. Its severity classification of "high" signals how the issuing agency weighs the risk of harm if no action is taken - "critical" and "high" tier alerts typically carry direct consumer actions, while "medium" and "low" tend toward informational guidance or monitoring advisories. The category it belongs to - FDA Recalls - determines the consumer-protection framework behind it, which shapes what remedies (refunds, replacements, repairs, or the recall itself) are available to affected consumers and which agency holds statutory responsibility for enforcement.
Most readers skim a notice like this, check whether they are personally affected, and move on. The more useful lens is to verify its scope, source, and timestamp, then compare related notices without assuming that one record proves a broader trend.
Areazine pairs this record with the original agency URL so you can check the primary source before acting. Its related labels are recall, product-safety, fda, MedicalDevices.
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.
Original source: FDA Official Notice ↗
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