Quick Facts at a Glance
- Recall Date
- January 7, 2026
- Hazard Level
- HIGH
- Brand
- Medline Industries, LP
- Category
- Health & Personal Care
- Sold At
- Multiple Retailers
- Geographic Scope
- 1 states
- At-Risk Groups
- GENERAL
What to Do Now
Use this page like a recall checklist: verify the product first, then act on the official remedy.
Immediate steps
- 1Stop using the product until you confirm whether it is included in the recall.
- 2Compare the product label, model number, UPC, color, size, and purchase location against the identifiers below.
- 3Follow the official remedy from FDA - Medical Devices; save photos, receipts, labels, and correspondence before contacting the company.
- 4If the product could harm a child, older adult, pet, or patient, move it out of reach immediately.
Check these identifiers
- Brand
- Medline Industries, LP
- Product type
- Burn Care Kits
- Model numbers
- 1) DYNJ15668R, UDI-DI: 10195327108502(each), 40195327108503(case), Lot Number: 23HMB037, 2) DYNJ42829B, UDI-DI: 10193489880151(each), 40193489880152(case), Lot Number: 22IBI084 +4 more
- Sold at
- Multiple Retailers
- Where affected
- ALL
Recall Timeline
Key dates and source checks for this recall record.
Recall announced
January 7, 2026
Reported by FDA DEVICE
February 25, 2026
RecallRadar source check
March 4, 2026
Consumer action
Use the official remedy and keep documentation.
Hazard Information
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.
What You Should Do
Patients and healthcare providers should stop using this device immediately. Follow the recall instructions provided by the manufacturer. Contact Medline Industries, LP or your healthcare provider for instructions. Notification method: Letter
About This Product
Burn care kits are essential for treating burns and related injuries. Consumers purchase these kits for home use or in healthcare settings for immediate treatment of burn injuries.
Why This Is Dangerous
The sterilization calibration issues could lead to a lack of sterility in the burn care kits, increasing the risk of infections or complications when used on patients.
Industry Context
This recall is not part of a broader industry pattern.
Real-World Impact
Consumers who own these burn care kits should stop using them immediately to prevent potential health risks. The recall may cause inconvenience but is critical for patient safety.
Practical Guidance
How to identify if yours is affected
- Check the model number of your burn care kit: DYNJ15668R, DYNJ42829B, or DYNJT3437.
- Verify the lot number against the recalled lot numbers: 23HMB037, 22IBI084, 25FBK633.
- Contact Medline Industries if unsure about your product's status.
Where to find product info
Model and lot numbers are usually located on the packaging or the product label of the burn care kit.
What timeline to expect
Expect a refund or replacement processing time of 4-6 weeks once initiated with Medline Industries.
If the manufacturer is unresponsive
- Document your communication attempts with Medline Industries.
- Consider reaching out to the FDA for further guidance if no response is received.
How to prevent similar issues
- Always check for recalls before purchasing medical devices.
- Look for products with clear sterilization certifications and standards.
- Purchase from reputable suppliers and retailers.
Documentation advice
Keep records of your purchase, any correspondence related to the recall, and photographs of the product for your own records.
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Product Details
The recalled burn care kits include: 1) BURN PACK, Model Number: DYNJ15668R; 2) BURN PACK-LF, Model Number: DYNJ42829B; 3) BURN CARE PACK-LF, Model Number: DYNJT3437. These products were distributed worldwide and sold in the U.S. since their manufacturing.
Key Facts
- Recall date: January 7, 2026
- Class II recall
- Users advised to stop use immediately
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Safety Guide
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