Medline Industries, LP — Medline Convenience Kits: 1) BURN PACK, Model Number: DYNJ15668R; 2) BURN PACK-LF, Model Number: DYNJ42829B; 3) BURN CARE PACK-LF, Model Number: DYNJT3437
⚠️ 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.
Is this relevant to me?
- Geography
- Nationwide
- Source agency
- FDA
- Category
- Health
- Published
- January 7, 2026
Worldwide distribution - US Nationwide.
What's affected?
- 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
- Lot code
- 23HMB037
Additional details
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
What should I do?
Recommended action
Class II recall. Voluntary: Firm initiated Quantity affected: 291 units.
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