Medline Industries Recalls Over 117,000 Convenience Kits Due to Sterility Concerns

What Happened

Medline Industries, LP has initiated a voluntary Class II recall of various medical convenience kits due to identified issues with the calibration of equipment used during the sterilization and packaging process. While all affected products were exposed to validated sterilization and packaging cycles, the firm determined that the calibration discrepancies have the potential to impact the sterility assurance level (SAL) of the devices.

Which Products Are Affected

The recall affects a total of 117,907 units distributed nationwide in the United States and worldwide. The products include a wide range of surgical and procedure kits, such as:

• Spinal and Neuro Kits: SPINAL CDS (Model CDS940087AG, CDS940087AI), KIT NEURO CRANIOTOMY (DYKMBNDL141, DYKMBNDL144), and LAMI FUSION (CDS982035W).
• Joint and Orthopedic Kits: TOTAL HIP CDS-LF (Model CDS980832Q, CDS980832R, CDS980832S), TOTAL KNEE CDS (Model CDS981454K, CDS981454L), and KNEE ARTHROSCOPY CDS (Model CDS981502K).
• Other Kits: JOINT ASPIRATION KIT (DYKM1161) and LOWER EXTREMITY CDS (CDS983049K).

Affected lot numbers include a vast range of codes such as 21EBC900, 22GBE442, 23JBI054, 24DMH818, and 25BMJ035. The recall covers products with initiation dates starting from January 7, 2026.

What You Should Do

Medline Industries began notifying affected customers and distributors via letter on January 7, 2026. Facilities and healthcare providers should immediately check their inventory for the model and lot numbers listed in the recall notice. Affected products should be sequestered and handled according to the instructions provided in the firm’s notification letter. For further information regarding returns or replacement products, customers can contact Medline Industries, LP at 3 Lakes Dr, Northfield, IL 60093-2753.

Why This Matters

Sterility is critical for medical devices used in invasive procedures. A potential compromise in the sterility assurance level increases the risk of post-operative infections or other complications for patients undergoing spinal, orthopedic, or neurological surgeries.

Source

Information provided by the FDA under recall number Z-1421-2026.