Medline Industries Recalls Surgical and Medical Convenience Kits Over Sterility Concerns

What Happened

Medline Industries, LP has initiated a voluntary Class II recall for several types of medical convenience kits. The company identified issues related to the calibration of equipment used to sterilize and package these devices. While all products were exposed to validated sterilization and packaging cycles, the calibration errors have the potential to impact the sterility assurance level (SAL) of the affected products.

Which Products Are Affected

A total of 7,725 units are included in this recall, distributed nationwide in the United States and worldwide. The recall affects 31 specific convenience kit models, including:

• Robotic Surgery/Urology Kits: CDS982407N, DYKMBNDL109A, DYKMBNDL116A, DYKMBNDL116G, DYNJ04135B
• GYN and Lithotomy Kits: CDS985431K, CDS985431O, DYNJ04382J, DYNJ47713A, DYNJ55377D, DYNJ80765C, DYNJ83475, DYNJ902711L, DYNJ902711N, DYNJT6424
• D&C (Dilation and Curettage) Packs: DYNJ0665843C, DYNJ22567G, DYNJ22567J, DYNJ41272B, DYNJ41272C, DYNJ67214D, DYNJ67214F, DYNJ67214G, DYNJ67214I, DYNJ87468, DYNJ900465C, DYNJ900465D, DYNJ900465F, DYNJ906947C
• Other Specialized Packs: OB PACK (DYNJ42884) and ANTERIOR CERVICAL-LF (DYNJ58344)

Specific lot numbers and UDI-DI information for each model are detailed in the official FDA enforcement report under recall number Z-1419-2026.

What You Should Do

Medline Industries notified affected customers via letter starting January 7, 2026. Healthcare facilities and distributors should immediately check their inventory for the model and lot numbers listed in the recall. Affected products should be quarantined and handled according to the instructions provided in the firm’s notification letter. For further information, customers can contact Medline Industries, LP at 3 Lakes Dr, Northfield, IL 60093.

Why This Matters

Sterility is critical for medical devices used in surgical and clinical procedures. If the sterility assurance level is compromised, there is an increased risk of patient infection or other complications during medical interventions.

Source

FDA Recall Notice - Recall Event ID 98329.