DJO recalled 1,594 Cold Form Wraps for back and shoulder use nationwide through multiple retailers. The IFU directs heating in a microwave for 3 minutes, which can cause leaks or seam breaks and temperatures high enough to cause a second-degree burn. Stop using the device and follow the manufacturer’s recall instructions.
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.
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
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The recall concerns a back and shoulder cold/hot therapy wrap used for compression and temperature therapy in healthcare or home settings.
The microwave heating instruction can cause leaks or seam breaks and may raise surface temperatures enough to cause a second-degree burn.
This recall is not described as part of a broader industry pattern.
Consumers who heat per IFU risk burns and device leakage. The recall involves 1,594 units distributed nationwide; immediate discontinuation is advised.
Model labels and packaging should contain the model and date/UDI information.
Refunds or replacements typically take 4-8 weeks once initiated.
Keep product, packaging, and date codes; save recall notices and communications; photograph any damage or leakage; retain receipts in case of refunds or replacements.
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.
No injuries or incidents have been reported.
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