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Medium risk Medical DevicesClass II

Medline Triple Lumen Insertion Kit Recall

Medline Convenience Kits: 1) KIT TRIPLE LUMEN INSERTION, Model Number: DYNDM1031A

Updated January 7, 2026

Medline is recalling Triple Lumen Insertion Kits due to sterilization equipment calibration issues that may have compromised the sterility of the devices. Use of non-sterile medical equipment can lead to serious infection.

Is the Medline Industries, LP recalled? Yes. This product was recalled by FDA on January 7, 2026. Details below.

What is recalled

Medline Convenience Kits: Triple Lumen Insertion, Model Number DYNDM1031A.

Am I affected

You're affected if you have a Medline Triple Lumen Insertion Kit with model number DYNDM1031A.

What to do right now

Stop using this kit immediately. Contact Medline Industries, LP for return instructions or a replacement. Do not use any affected kits for patient care.

The hazard

Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed to the validated sterilization and packaging cycles; however, the identified calibration issues have the potential to impact the sterility assurance level (SAL) of the Recalled Products.

Brands affected

Medline Industries, LP
Source
FDA
Category
Medical Devices
Recall ID
fda-Z-1407-2026
Classification
Class II
Recalled
January 7, 2026
Read the official notice

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