Medline Industries Recalls Over 39,000 Convenience Kits Due to Sterility Concerns

What Happened

Medline Industries, LP has initiated a voluntary Class II recall of approximately 39,315 convenience kits. The recall was prompted by the discovery of calibration issues with the equipment used to sterilize and package the devices. Although the products were exposed to validated sterilization cycles, the identified calibration discrepancies have the potential to impact the sterility assurance level (SAL) of the kits.

Which Products Are Affected

The recall affects a wide range of Medline Convenience Kits used in surgical procedures. Affected models include, but are not limited to:

• Open Heart CDS: Models CDS840015AQ, CDS840023T, CDS840428K, CDS840428L, CDS983513F, CDS984276P, CDS984355F, CDS984355G, CDS984355I, CDS984355J
• Off Pump CABG CDS: Models CDS840087AI, CDS840087AK, CDS840087AL
• Vascular Kits: Models CDS985215C, DYKMBNDL11, DYKMBNDL118, DYKMBNDL118A, DYKMBNDL120, DYKMBNDL14, DYKMBNDL152
• Other Specialized Kits: Pacemaker CDS (CDS980839C), Heart CABG CDS, and various Urology and Thoracic kits.

The recall involves 39,315 units distributed worldwide and nationwide across the United States. Official recall number: Z-1390-2026.

What You Should Do

Medline Industries began notifying affected customers via letter on January 7, 2026. Healthcare facilities and distributors should immediately check their inventory for the affected model and lot numbers. If you have these products in stock, follow the instructions provided in the firm’s notification letter regarding the return or segregation of the kits.

For further information, 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 surgical procedures, such as open-heart surgery. A failure to meet the required sterility assurance level could increase the risk of post-operative infections for patients.

Source

This information is based on official recall data provided by the FDA.