Medline Industries, LP: Medline Convenience Kits: 1) BURN PACK, Model Number: DYNJ15668R;

Medline Industries, LP: Medline Convenience Kits: 1) BURN PACK, Model Number: DYNJ15668R; 2) BURN PACK-LF, Model Number: DYNJ42829B; 3) BURN CARE PACK-LF, Mode

Medical DevicesSource: FDA (device) · Date: 2026-02-25

The text below is copied from the official FDA (device) record. If anything differs, the official notice is correct.

Company / brand: Medline Industries, LP
Product: Medline Convenience Kits: 1) BURN PACK, Model Number: DYNJ15668R; 2) BURN PACK-LF, Model Number: DYNJ42829B; 3) BURN CARE PACK-LF, Model Number: DYNJT3437
Reason / hazard: 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
Status: Ongoing
Distribution / sold at: Worldwide distribution - US Nationwide.
Recall initiated: 2026-01-07
Code info: 1) DYNJ15668R, UDI-DI: 10195327108502(each), 40195327108503(case), Lot Number: 23HMB037; 2) DYNJ42829B, UDI-DI: 10193489880151(each), 40193489880152(case), Lot Number: 22IBI084; 3) DYNJT3437, UDI-DI: 10198459325076(each), 40198459325077(case), Lot Number: 25FBK633
Product quantity: 291 units
Voluntary mandated: Voluntary: Firm initiated
City: Northfield
State: IL
Country: United States
Event id: 98329