Medline Recalls Triple Lumen Insertion Kits Over Sterilization Equipment Calibration Issues
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Medline Industries, LP is recalling 15 Triple Lumen Insertion Kits (Model DYNDM1031A) due to equipment calibration issues that may compromise the sterility of the medical devices.
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 voluntarily initiated a recall of specific Triple Lumen Insertion Kits. The recall was issued after the company identified calibration issues with the equipment used to sterilize and package the devices. While the products were exposed to validated sterilization cycles, the calibration errors have the potential to impact the Sterility Assurance Level (SAL) of the kits.
Which Products Are Affected
The recall affects 15 units of the following product:
- Product Name: Medline Convenience Kits: KIT TRIPLE LUMEN INSERTION
- Model Number: DYNDM1031A
- Lot Number: 23EBM150
- UDI-DI: 10884389555897 (individual unit); 40884389555898 (case)
- Recall Number: Z-1407-2026
The affected products were distributed worldwide, including nationwide across the United States.
What You Should Do
Healthcare providers and distributors should immediately check their inventory for the affected lot number (23EBM150). Medline Industries, LP notified customers of the issue via a formal letter. If you possess any of the recalled units, follow the instructions provided in the firm's notification regarding the return or quarantine of the devices. For further inquiries, contact Medline Industries, LP at their headquarters in Northfield, Illinois.
Why This Matters
Maintaining the sterility of medical insertion kits is critical for patient safety. A compromised Sterility Assurance Level increases the risk of infection or sepsis during clinical procedures involving triple lumen insertion.
Source
Information provided by the FDA under recall event ID 98329.
Original source: FDA Official Notice ↗
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