device recall
saveDJO, LLC device recall (Cls II)
September 25, 2025updated 3mo ago
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Cold Form Wrap: Back, REF: DP163CT03-BLK-L,XL, and Shoulder, REF: DP163CT02 — Reason: 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. — Status: Ongoing
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