Medline Industries Recalls 30,958 Convenience Kits Over Sterility Concerns

What Happened

Medline Industries, LP has initiated a voluntary recall of various medical convenience kits due to calibration issues with equipment used during the sterilization and packaging process. While the products were exposed to validated sterilization cycles, the identified calibration errors have the potential to impact the Sterility Assurance Level (SAL) of the devices.

Which Products Are Affected

The recall affects 30,958 units distributed nationwide in the United States and worldwide. The recall involves 48 different types of convenience kits, including but not limited to:

• OR Arteriogram: Model CDS985094F
• CVC Bundle Kits: Models ECVC6225A, ECVC7265A
• Cath Lab Packs: Models DYNJ30955I, DYNJ31773K, DYNJ68633, DYNJ81197B/C/D/F/G, DYNJ83089
• Angiography Packs: Models DYNJ0954970I, DYNJ43415D, DYNJ43415F, DYNJ53129D
• Surgical Oncology Kits: Model DYKMBNDL153
• Vein Procedure Kits: Model DYNDA2076C
• Cardiac Cath Packs: Models DYNJ0150605AC, DYNJ19946M, DYNJ35300M, DYNJ39066B, DYNJ47370B, DYNJ58048C

Specific lot numbers and UDI-DI information for each affected model are associated with official recall number Z-1389-2026.

What You Should Do

Medline Industries initiated the recall on January 7, 2026, and began notifying customers via an initial firm notification letter. Healthcare facilities and providers should immediately review their inventory for the affected model and lot numbers. Consumers and medical staff should follow the specific instructions provided in the Medline notification letter regarding the return or disposal of these products.

Why This Matters

Sterility is essential for medical devices used in invasive surgical and catheterization procedures. A potential failure to meet sterility assurance levels increases the risk of patient infection and other serious health complications.

Source

Information provided by the FDA.