DONJOY PERFORMANCE DP163CT02Recalls & reported problems
Djo, LLC · DJP COLDFORM SHOULDER WRAP, BLACK, UNIVERSAL · Class 1
1 open recall names this device. See the recall details and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 0
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 1
Summary
No MAUDE adverse event reports in our data reference this device identifier directly.
1 FDA recall record name this device's identifier, 1 still open.
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.
Recalls naming this device
- Sep 25, 2025Open, Classified
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.
Z-0722-2026 · Root cause: Labeling Change Control · FDA record ↗
Other Pack, hot or cold, reusable devices
- CARDINAL HEALTH 70304ACardinal Health 200, LLC · Pack, hot or cold, reusable1 recall2 reports
- DONJOY PERFORMANCE DP163CT03-BLK-L,XLDjo, LLC · Pack, hot or cold, reusable1 recall0 reports
- CARDINAL HEALTH 80304ACardinal Health 200, LLC · Pack, hot or cold, reusable1 report
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.