Medline Industries Recalls Chest/Breast Convenience Kits Due to Sterility Concerns

What Happened

Medline Industries, LP has initiated a voluntary recall of specific convenience kits used for chest and breast procedures. The company identified calibration issues with the equipment used to sterilize and package the devices. While the products were exposed to validated sterilization and packaging cycles, the identified calibration errors have the potential to impact the Sterility Assurance Level (SAL) of the recalled products.

Which Products Are Affected

The recall affects 150 units of the following product:

• Product Name: Medline Convenience Kits: CHEST/BREAST-LF
• Model Number: DYNJ83950
• Recall Number: Z-1412-2026
• Affected Lot Numbers: 24DBT832, 24CBH626, 23LBR075, 23FBF248, and 23CBG610
• UDI-DI: 10195327318925 (each), 40195327318926 (case)

These products were distributed nationwide across the United States and worldwide.

What You Should Do

Medline notified affected customers via letter starting in January 2026. Healthcare providers and facilities should immediately check their inventory for the affected lot numbers listed above. Any matching products should be sequestered and handled according to the instructions provided in the firm’s notification letter. For further information or questions regarding the return process, contact Medline Industries, LP at their Northfield, Illinois headquarters.

Why This Matters

Sterility is critical for medical devices used in surgical procedures. A failure to meet the required Sterility Assurance Level (SAL) could increase the risk of infection for patients undergoing chest or breast procedures.

Source

Information provided by the FDA under Recall Event ID 98329.