Medline Industries Recalls Convenience Kits Over Potential Sterility Concerns
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Medline Industries, LP is recalling specific LVAD Driveline Trays and Surgical Oncology Kits because calibration issues may have compromised the products' sterility.
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 "medium" 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, Devices.
What Happened
Medline Industries, LP has initiated a voluntary recall of specific 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.
Which Products Are Affected
The recall affects 684 units distributed nationwide in the United States and worldwide. The specific products and lot numbers include:
LVAD DRIVELINE TRAY
- Model Number: DM1035
- Lot Number: 21BBN221
- UDI-DI: 10193489442755 (each), 40193489442756 (case)
KIT SURG ONC INSERT CENT.VENOU
- Model Number: DYKMBNDL43
- UDI-DI: 10193489478891 (each), 40193489478892 (case)
- Lot Numbers: 22GBN333, 22GBF510, 22EBL039, 22CBU342, 21JBJ253, 21IBJ337, 21DBD662, 21ABO838, 21ABJ003
What You Should Do
Medline Industries notified affected customers through a formal recall letter initiated on January 7, 2026. Healthcare providers and facilities should immediately check their inventory for the affected model and lot numbers. If these products are found, they should be quarantined and handled according to the instructions provided in the firm's notification letter.
Why This Matters
The sterility of medical kits is critical for patient safety during surgical and clinical procedures. A failure to meet the required Sterility Assurance Level could increase the risk of infection or other medical complications for patients.
Source
Information provided by the FDA under recall number Z-1402-2026.
Original source: FDA Official Notice ↗
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