Recall Z-1401-2026— Medline Industries, LP
Class II · Ongoing
Class II FDA medical device recall by Medline Industries, LP, initiated 2026-01-07. FDA's recall record names no specific 510(k) clearance for this event. 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..
- Recalling firm
- Medline Industries, LP
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2026-01-07
- Firm location
- Northfield, IL, United States
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.