HIGH

DJO Recalls Cold Compression Wrap Over Burn Hazard

DJO recalled 1,594 cold compression wraps on September 25, 2025. The wraps may leak or break when heated in the microwave, posing a burn risk. The recall affects models REF: DP163CT03-BLK-L, XL, and DP163CT02.

Quick Facts at a Glance

Recall Date
September 25, 2025
Hazard Level
HIGH
Brand
DJO
Category
Health & Personal Care
Sold At
Multiple Retailers
Geographic Scope
1 states
At-Risk Groups
GENERAL

Hazard Information

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.

What You Should Do

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

Get instant alerts for Health & Personal Care recalls

Be the first to know. Free instant alerts to your inbox.

No spamUnsubscribe anytime

Product Details

The recalled products include cold compression wraps for back and shoulder use, with model numbers DP163CT03-BLK-L, XL, and DP163CT02. These wraps were distributed nationwide across several states, including Wisconsin, Texas, and California.

The Hazard

Heating the compression wrap in the microwave for three minutes may cause it to leak or break at the seams. The wrap can also reach temperatures high enough to cause second-degree burns.

Reported Incidents

There are no specific reported injuries, but the potential for serious burn risk exists due to the product's design and instructions.

What to Do

Stop using the cold compression wrap immediately. Contact DJO, LLC or your healthcare provider for further instructions and follow the recall guidelines.

Contact Information

For more information, visit the FDA recall page at https://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Product-Tabs.cfm?recall_number=Z-0722-2026.

Key Facts

  • 1,594 units recalled
  • Models: DP163CT02, DP163CT03-BLK-L, XL
  • High burn risk if heated
  • Stop using immediately and follow recall instructions

Get Alerts for Health & Personal Care Recalls

Get instant alerts for recalls that affect you. Free forever.

Safety Assessment

Risk LevelHIGH
Severity Score
8/ 10
Affected Groups
GENERAL
Injury Types
BURN

Product Classification

Product TypeCold Compression Wrap
Sold At
Multiple Retailers

Product Details

Brand
Model Numbers
REF/UDI-DI/Lot: DP163CT02/00888912164382/190523
171221. DP163CT03-BLK-L
XL/00888912164481/150221
180821
Affected States
ALL
Report Date
December 3, 2025
Recall Status
ACTIVE

Related Recalls

HIGH

Fresenius Kabi Vancomycin Injection Recalled Over Sterility Concerns

Fresenius Kabi Compounding recalled its vancomycin HCl injection on February 5, 2026, due to a lack of assurance of sterility. This Class II recall affects all lots distributed nationwide. Healthcare providers and consumers must stop using the product immediately.

Fresenius Kabi Compounding
Lack of
Read more
HIGH

Fresenius Kabi Compounding Issues Recall of Vancomycin Injection

Fresenius Kabi Compounding recalled 1,578 bags of vancomycin HCl injection on February 5, 2026. The company cited a lack of assurance of sterility as the reason for the recall. Healthcare providers and consumers should stop using the product immediately.

Fresenius Kabi Compounding
Lack of
Read more
HIGH

Pro Numb Tattoo Numbing Spray Recalled Due to cGMP Violations

Pro Numb Tattoo Numbing Spray was recalled on February 2, 2026 due to cGMP deviations. The product, containing 4% lidocaine, is distributed by Pro Numb Tattoo Numbing Spray LLC. Consumers should stop using it immediately and contact the company for further guidance.

PRO NUMB SENSITIVE SKIN
cGMP deviations
Read more