Medline Burn Care Kits Recalled Due to Sterilization Calibration Issues
Medline Industries is recalling three burn care convenience kits because calibration issues with sterilization and packaging equipment could compromise their sterility assurance level.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: This is an FDA Class II recall for a medical device. The hazard is a potential compromise to sterility assurance due to equipment calibration issues, but the source text does not report any confirmed illnesses, injuries, or hospitalization cases. The risk is procedural and theoretical in nature.
Plain-English summary
Medline Industries, LP is recalling three Burn Care Convenience Kits: BURN PACK (Model DYNJ15668R), BURN PACK-LF (Model DYNJ42829B), and BURN CARE PACK-LF (Model DYNJT3437). A total of 291 units have been recalled.
The recall was initiated because of identified calibration issues with the equipment used to sterilize and package these devices. Although all products were exposed to validated sterilization and packaging cycles, the calibration issues have the potential to impact the sterility assurance level of the recalled products.
These products were distributed nationwide in the United States and worldwide. Consumers and healthcare providers who have received these kits should contact Medline Industries, LP for instructions on return or replacement of the affected units. The lot numbers for the recalled products are: 23HMB037 (DYNJ15668R), 22IBI084 (DYNJ42829B), and 25FBK633 (DYNJT3437).
The recalled product
- 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
- Manufacturer
- Medline Industries, LP
- Hazard
- sterilization-defect
- sterility-assurance
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (12)
- 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
Distribution
Distributed nationwide across the United States.
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