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) N

Recall Summary Medline is recalling six medical convenience kits and trays used for procedures like feeding tube insertion, catheter placement, and knee surgery because equipment used to sterilize and package these products may not have been properly calibrated. This calibration issue could potentially affect whether the products are properly sterilized, even though they went through the sterilization process. The recall affects medical facilities and healthcare providers who use these Medline products.

Product

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

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.

Classification

Class II

Category

consumer product recall

Country

United States

Agency

FDA-DEVICES

Recall date

2026-01-07

Status

Open, Classified

Official recall notice from FDA-DEVICES

Recall details on Nibble Recalls: https://trynibble.app/recalls/468f6439-35fc-4ad9-8cdf-3fca3d2e3f63