Medline Industries Recalls Convenience Kits Due to Potential Sterility Concerns

What Happened

Medline Industries, LP has initiated a voluntary recall of several convenience kits. The company identified issues related to the calibration of equipment used to sterilize and package these medical devices. While all products were exposed to validated sterilization and packaging cycles, the identified calibration issues have the potential to impact the Sterility Assurance Level (SAL) of the recalled products.

Which Products Are Affected

The recall affects 553 units distributed worldwide and nationwide across the United States. The following products and lot numbers are included:

• KIT ACES INSERT PEG (Model: DYKMBNDL130): Lots 21BBB580, 21ABJ543, 21ABC197
• KIT ACES INSERT PEG (Model: DYKMBNDL130A): Lots 22GLB021, 22GLA694, 22FLA745, 22ELA008, 22DLA407, 22CLA448, 22BLA721, 22ALA593, 21JLA910, 21ILA163, 21HLA740, 21GLA677, 21FLA214, 21ELA080, 21DLA326, 21CLA621, 21CLA391Z, 21CLA391
• KIT ACES INSERT PERCUTANEOUS T (Model: DYKMBNDL4): Lots 21DLA343, 21ALA631, 21ALA056
• NICU LINE CHANGE TRAY (Model: LC295): Lot 2025110490
• OSC SHERMAN KNEE ARTHRO BASIC (Model: DYKM1977C): Lot 2024110190
• PICC CATHETER INSERTION TRAY (Model: CVI4300): Lot 2020120950

What You Should Do

Medline initiated the recall via notification letters on January 7, 2026. Healthcare providers and consumers should immediately check their inventory for the affected model numbers and lot numbers listed above. If you possess any of the recalled kits, follow the instructions provided in the firm’s notification letter. For further inquiries, contact Medline Industries, LP at 3 Lakes Dr, Northfield, IL 60093-2753.

Why This Matters

Sterility is critical for medical devices used in clinical procedures; a compromised Sterility Assurance Level could potentially lead to patient infections or other health complications.

Source

Recall information provided by the FDA. Recall Number: Z-1401-2026.