Quick Facts at a Glance
- Recall Date
- September 25, 2025
- Hazard Level
- HIGH
- Brand
- DJO
- 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
- DJO
- Product type
- Hot and Cold Therapy Wrap
- Model numbers
- REF/UDI-DI/Lot: DP163CT02/00888912164382/190523, 171221. DP163CT03-BLK-L, XL/00888912164481/150221, 180821
- Colors
- Black
- Sizes
- L, XL
- Sold at
- Multiple Retailers
- Where affected
- ALL
Recall Timeline
Key dates and source checks for this recall record.
Recall announced
September 25, 2025
Reported by FDA DEVICE
December 3, 2025
RecallRadar source check
April 18, 2026
Consumer action
Use the official remedy and keep documentation.
Hazard Information
The IFU (Information for Use) on the wrap instructs the user to heat the hot and cold compression wrap in the microwave for 3 minutes, which may cause the wrap to leak or break at the seams and/or reach temperatures capable of causing a second degree burn.
What You Should Do
Patients and healthcare providers should stop using this device immediately. Follow the recall instructions provided by the manufacturer. Contact DJO, LLC or your healthcare provider for instructions. Notification method: N/A
About This Product
The recall concerns a back and shoulder cold/hot therapy wrap used for compression and temperature therapy in healthcare or home settings.
Why This Is Dangerous
The microwave heating instruction can cause leaks or seam breaks and may raise surface temperatures enough to cause a second-degree burn.
Industry Context
This recall is not described as part of a broader industry pattern.
Real-World Impact
Consumers who heat per IFU risk burns and device leakage. The recall involves 1,594 units distributed nationwide; immediate discontinuation is advised.
Practical Guidance
How to identify if yours is affected
- Check if your wrap is a DP163CT02 or DP163CT03-BLK-L (L or XL sizes).
- Inspect date codes printed on the device: 190523, 171221, 150221, 180821.
Where to find product info
Model labels and packaging should contain the model and date/UDI information.
What timeline to expect
Refunds or replacements typically take 4-8 weeks once initiated.
If the manufacturer is unresponsive
- Document all communications with the manufacturer.
- File a complaint with the CPSC if the company is unresponsive.
- Consult legal counsel if medical injuries occur or concerns persist.
How to prevent similar issues
- Do not heat therapy wraps in a microwave unless the IFU explicitly allows it.
- Follow all manufacturer instructions for any heat therapy device.
- When shopping for therapy wraps, verify safe heating guidelines and recall status.
- Check recall databases before using medical devices.
Documentation advice
Keep product, packaging, and date codes; save recall notices and communications; photograph any damage or leakage; retain receipts in case of refunds or replacements.
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Product Details
Model numbers and identifiers: DP163CT02; DP163CT03-BLK-L; XL. UDI/LOT references include: DP163CT02/00888912164382/190523; 171221. DP163CT03-BLK-L; XL/00888912164481/150221; 180821. Sold nationwide in the United States through multiple retailers. Distribution includes: WI, TN, TX, MD, GA, UT, WA, MI, NC, NE, CA, MA, CO, SC, OH, IN, MN, NM, PA, NY, IL, FL, NJ, VA, AZ, VT, CT, OK. Price not disclosed.
Reported Incidents
No injuries or incidents have been reported.
Key Facts
- 1,594 total units recalled
- Models/refs: DP163CT02 and DP163CT03-BLK-L (L and XL sizes)
- Distribution: Nationwide across 50 states (list provided)
- Remedy: Stop using and contact DJO for instructions
- Status: ACTIVE recall
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Safety Guide
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