Medline Industries Recalls 154,427 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 all affected 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 a total of 154,427 units distributed nationwide in the U.S. and worldwide. The products include a vast range of Medline Convenience Kits used in various medical procedures. Affected model series include:

• ACC Series: Including Model Numbers ACC010326, ACC010326A, ACC010475, ACC010542, ACC010543, ACC010722, and ACC010896.
• CDS Series: Including Model Numbers CDS860063U, CDS860066T, CDS981795G, CDS982414N, CDS982823R, CDS982895I, CDS983069F, CDS983376S, CDS983611N, CDS983653K, CDS983653L, CDS983653M, CDS983908Q, CDS984244I, CDS985431M, and CDS985557L.
• DYK/DYKM/DYNJ Series: Hundreds of surgical and procedure kits including Prep Kits, GI Packs, Maternity Kits, Robotics Urology Kits, and Ortho Total Shoulder Kits.
• EDUC and MNS Series: Including EDUC05000A, EDUC05041, MNS13935, and MNS3710A.

Specific lot numbers and UDI-DI information for these products are extensive, covering production ranges from 2020 through 2025. Official recall number: Z-1399-2026.

What You Should Do

Medline Industries notified affected customers and distributors via a formal letter initiated on January 7, 2026. Healthcare facilities and providers should immediately check their inventory for the model and lot numbers listed in the recall notification. Affected products should be quarantined and handled according to the specific instructions provided in the firm’s notification letter.

Why This Matters

This recall is significant because medical kits must maintain a specific Sterility Assurance Level to ensure patient safety. Equipment calibration issues could result in non-sterile products being used in surgical or clinical environments, potentially leading to patient infections or other health complications.

Source

Information provided by the FDA.