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U.S. Department of Health and Human Services

Class 2 Device Recall DONJOY PERFORMANCE

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 Class 2 Device Recall DONJOY PERFORMANCEsee related information
Date Initiated by FirmSeptember 25, 2025
Date PostedNovember 26, 2025
Recall Status1 Open3, Classified
Recall NumberZ-0722-2026
Recall Event ID 97610
Product Classification Pack, hot or cold, reusable - Product Code IME
ProductCold Form Wrap: Back, REF: DP163CT03-BLK-L,XL, and Shoulder, REF: DP163CT02
Code Information REF/UDI-DI/Lot: DP163CT02/00888912164382/190523, 171221. DP163CT03-BLK-L,XL/00888912164481/150221, 180821
Recalling Firm/
Manufacturer		 DJO, LLC
5919 Sea Otter Pl Ste 200
Carlsbad CA 92010-6750
Manufacturer Reason
for Recall		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.
FDA Determined
Cause 2		Labeling Change Control
ActionPer 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 any other organization, consignee, or user where these products were transferred. If you have any questions you can reach the firm via email at productsafety@enovis.com
Quantity in Commerce1,594
DistributionUS 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.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
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