Medline Convenience Kits: 1) KIT ACES INSERT PEG, Model Number: DYKMBNDL130; 2) KIT ACES INSER...
FDA Recall #Z-1401-2026 — Class II — January 7, 2026
Product Description
Medline Convenience Kits: 1) KIT ACES INSERT PEG, Model Number: DYKMBNDL130; 2) KIT ACES INSERT PEG, Model Number: DYKMBNDL130A; 3) KIT ACES INSERT PERCUTANEOUS T, Model Number: DYKMBNDL4; 4) NICU LINE CHANGE TRAY, Model Number: LC295; 5) OSC SHERMAN KNEE ARTHRO BASIC, Model Number: DYKM1977C; 6) PICC CATHETER INSERTION TRAY, Model Number: CVI4300
Reason for Recall
Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed to the validated sterilization and packaging cycles; however, the identified calibration issues have the potential to impact the sterility assurance level (SAL) of the Recalled Products.
Recalling Firm
Medline Industries, LP — Northfield, IL
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Devices
Product Quantity
553 units
Distribution
Worldwide distribution - US Nationwide.
Code Information
1) DYKMBNDL130, UDI-DI: 10193489479027(each), 40193489479028(case), Lot Number: 21BBB580; 2) DYKMBNDL130, UDI-DI: 10193489479027(each), 40193489479028(case), Lot Number: 21ABJ543; 3) DYKMBNDL130, UDI-DI: 10193489479027(each), 40193489479028(case), Lot Number: 21ABC197; 4) DYKMBNDL130A, UDI-DI: 10193489829594(each), 40193489829595(case), Lot Number: 22GLB021; 5) DYKMBNDL130A, UDI-DI: 10193489829594(each), 40193489829595(case), Lot Number: 22GLA694; 6) DYKMBNDL130A, UDI-DI: 10193489829594(each), 40193489829595(case), Lot Number: 22FLA745; 7) DYKMBNDL130A, UDI-DI: 10193489829594(each), 40193489829595(case), Lot Number: 22ELA008; 8) DYKMBNDL130A, UDI-DI: 10193489829594(each), 40193489829595(case), Lot Number: 22DLA407; 9) DYKMBNDL130A, UDI-DI: 10193489829594(each), 40193489829595(case), Lot Number: 22CLA448; 10) DYKMBNDL130A, UDI-DI: 10193489829594(each), 40193489829595(case), Lot Number: 22BLA721; 11) DYKMBNDL130A, UDI-DI: 10193489829594(each), 40193489829595(case), Lot Number: 22ALA593; 12) DYKMBNDL130A, UDI-DI: 10193489829594(each), 40193489829595(case), Lot Number: 21JLA910; 13) DYKMBNDL130A, UDI-DI: 10193489829594(each), 40193489829595(case), Lot Number: 21ILA163; 14) DYKMBNDL130A, UDI-DI: 10193489829594(each), 40193489829595(case), Lot Number: 21HLA740; 15) DYKMBNDL130A, UDI-DI: 10193489829594(each), 40193489829595(case), Lot Number: 21GLA677; 16) DYKMBNDL130A, UDI-DI: 10193489829594(each), 40193489829595(case), Lot Number: 21FLA214; 17) DYKMBNDL130A, UDI-DI: 10193489829594(each), 40193489829595(case), Lot Number: 21ELA080; 18) DYKMBNDL130A, UDI-DI: 10193489829594(each), 40193489829595(case), Lot Number: 21DLA326; 19) DYKMBNDL130A, UDI-DI: 10193489829594(each), 40193489829595(case), Lot Number: 21CLA621; 20) DYKMBNDL130A, UDI-DI: 10193489829594(each), 40193489829595(case), Lot Number: 21CLA391Z; 21) DYKMBNDL130A, UDI-DI: 10193489829594(each), 40193489829595(case), Lot Number: 21CLA391; 22) DYKMBNDL4, UDI-DI: 10193489477627(each), 40193489477628(case), Lot Number: 21DLA343; 23) DYKMBNDL4, UDI-DI: 10193489477627(each), 40193489477628(case), Lot Number: 21ALA631; 24) DYKMBNDL4, UDI-DI: 10193489477627(each), 40193489477628(case), Lot Number: 21ALA056; 25) LC295, UDI-DI: 10653160322702(each), 00653160322705(case), Lot Number: 2025110490; 26) DYKM1977C, UDI-DI: 10653160381105(each), 00653160381108(case), Lot Number: 2024110190; 27) CVI4300, UDI-DI: 10653160294313(each), 00653160294316(case), Lot Number: 2020120950
Status
Ongoing
Voluntary / Mandated
Voluntary: Firm initiated