Recall Z-0722-2026 ยท IME Pack, Hot Or Cold, Reusable
DJO, LLC
Cold Form Wrap: Back, REF: DP163CT03-BLK-L,XL, and Shoulder, REF: DP163CT02
| Date | Nov 26, 2025 (initiated Sep 25, 2025) |
| Status | Open, Classified |
| 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. |
| Root cause | Labeling Change Control |
| Action | Per recall notice, customers were asked to do the following: Users should immediately discontinue all further use of this product and discard any opened/used units. If you have unopened, unused units in your possession, please contact firm Customer Service at (844) 331-7767. You will be provided with a return authorization number and shipping label that is required for proper return and identification of the device. All users must complete the acknowledgement and response form and return to productsafety@enovis.com This notice must be distributed to all those within your organization and to |
| Quantity | 1,594 |
| Distribution | US Nationwide distribution in the states of 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.