Medline Industries Recalls Over 27,000 Convenience Kits Due to Sterility Concerns

What Happened

Medline Industries, LP has initiated a voluntary Class II recall of various medical convenience kits. The company identified issues related to the calibration of equipment used during the sterilization and packaging process. Although the products were exposed to validated sterilization cycles, the calibration discrepancies have the potential to impact the Sterility Assurance Level (SAL) of the affected devices.

Which Products Are Affected

A total of 27,320 units are included in this recall. The affected products consist of 52 different Medline Convenience Kit models used in obstetric and gynecological procedures. Key models and descriptions include:

• OB Kits: Model DYKM2326
• Labor & Delivery Packs: Models DYKMBNDL165, DYKMBNDL31, DYKMBNDL38, DYNJ0456816O, DYNJ0456816P, DYNJ20546F, DYNJ44720B, DYNJ63216A, DYNJ63757A, DYNJ84393, MNS8950A
• Vaginal Delivery Packs: Models DYNJ04692S, DYNJ16621B, DYNJ16621C, DYNJ20979I, DYNJ20979J, DYNJ24108D, DYNJ35488F, DYNJ38481G, DYNJ38481I, DYNJ38481K, DYNJ51377G, DYNJ51794B, DYNJ55363A, DYNJ55363B, DYNJ61574, DYNJ61650, DYNJ62402A, DYNJ69544A, DYNJ901387A, MNS13550A, MNS7460A
• Specialized GYN Kits: Models DYKMBNDL165 (Tubal Ligat), DYNJ33590F (Hysterectomy), DYNJ40203A (Gynecology Vaginal), DYNJ65145 (GYN Pack)

The recall involves numerous lot numbers and UDI-DI codes. Distribution was nationwide across the United States and worldwide.

What You Should Do

Medline Industries, LP 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 notice. Affected products should be quarantined and handled according to the instructions provided by Medline. For further information regarding returns or replacements, contact Medline Industries, LP at 3 Lakes Dr, Northfield, IL 60093-2753.

Why This Matters

This recall is significant because the affected kits are used in sensitive medical procedures, including labor and delivery. A failure to meet sterility assurance levels could increase the risk of infection for patients undergoing these procedures.

Source

FDA Recall Number Z-1414-2026