Medline Industries Recalls LVAD Driveline and Central Line Dressing Trays Over Sterility Concerns
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Medline Industries, LP has recalled over 9,700 medical convenience kits due to equipment calibration issues that may have compromised the sterility of the 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, medical-devices.
What Happened
Medline Industries, LP has initiated a voluntary recall of several medical convenience kits due to identified issues with the calibration of equipment used during the sterilization and packaging process. While the products were exposed to validated sterilization cycles, the calibration discrepancies have the potential to impact the sterility assurance level (SAL) of the devices, meaning their sterility cannot be guaranteed.
Which Products Are Affected
A total of 9,720 units are included in this recall. The affected products were distributed nationwide in the United States and worldwide. The specific models and lot numbers are as follows:
- LVAD DRIVELINE TRAY (Model DM1035A)
- UDI-DI: 10653160345251 (each), 00653160345254 (case)
- Lot Numbers: 2025051290, 2025031190, 2023062390, 2023101290, 2022030390, 2022072590
- LVAD DRIVELINE TRAY (Model DM1035)
- UDI-DI: 10653160327752 (each), 00653160327755 (case)
- Lot Numbers: 2020042290, 2020052290, 2020072290, 2020082690
- CENTRAL LINE DRESSING CHANGE TRAY (Model DT8670A)
- UDI-DI: 00653160177473 (each), 10653160177470 (case)
- Lot Number: 2020051390
What You Should Do
Medline Industries notified affected customers via a formal recall letter. Healthcare facilities and distributors should immediately check their inventory for the model and lot numbers listed above. Any affected products should be quarantined and handled according to the instructions provided in the firm's notification letter. For further information regarding returns or replacement, contact Medline Industries, LP directly at their Northfield, IL headquarters.
Why This Matters
This recall is significant because the affected trays are used in critical medical procedures involving Left Ventricular Assist Devices (LVAD) and central lines. If the sterility of these kits is compromised, it poses a serious risk of infection to patients undergoing these procedures.
Source
This information is based on official recall data provided by the FDA under recall number Z-1411-2026.
Original source: FDA Official Notice ↗
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