Medline Industries Recalls Convenience Kits Over Sterility Concerns

What Happened

Medline Industries, LP has initiated a voluntary recall of various medical convenience kits due to potential sterility concerns. 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 errors have the potential to impact the sterility assurance level (SAL) of the affected devices.

Which Products Are Affected

A total of 1,496 units are included in this recall, which involves products distributed nationwide in the United States and worldwide. The affected items include the following Medline Convenience Kits:

• TOTE ABRAMS KNEE ARTHROSCOPY: Model DYKM1801B
• TOTE SEN OSC HAND REPAIR: Model DYKM1776
• TOTE MOMENI SB CAPSULOTOMY REC: Model DYKM1765A
• TOTE YAO OSC HAND REPAIR: Model DYKM1796A
• TOTE SB NGUYEN CAPSULOTOMY: Model DYKM1756A
• TOTE FOX OSC HAND REPAIR: Model DYKM1783A
• TOTE KAMAL OSC HAND REPAIR: Model DYKM1730A
• TOTE SB NGUYEN LIPOSUCTION: Model DYKM1927A
• TOTE YAO OSC WRIST ARTHROSCOPY: Model DYKM1807
• TOTE CURTIN OSC HAND REPAIR: Model DYKM1781A
• OSC SHERMAN KNEE ARTHRO BASIC: Model DYKM1977B
• TOTE CHANGE OSC HAND REPAIR: Model DYKM1751A
• TOTE CARROLL BLOCK BLOOD PATCH: Model DYKM1864
• TOTE SB STONE JWIRE LUMPECTOMY/SEN NODE: Model DYKM1925
• TOTE SAFRAN OSC HIP ARTHRSCPY: Model DYKM1767B
• CVC PACK: Model CVI4500A

Affected lot numbers range from 2020 to 2025, including specific lots such as 2024100790, 2025013190, and 2020121550. This recall is designated as FDA Recall Number Z-1400-2026.

What You Should Do

Medline Industries notified affected customers via a formal letter initiated on January 7, 2026. Healthcare providers and facilities 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 in the firm’s notification letter. For further information, customers may contact Medline Industries, LP at their Northfield, IL headquarters.

Why This Matters

Sterility is critical for medical devices used in surgical and clinical procedures; a failure in the sterilization process increases the risk of patient infection and related medical complications.

Source

This information is based on an official report from the FDA.