DJO Cold Form Back and Shoulder Wraps Recalled for Burn and Leakage Hazards

Agency Publication Date: November 26, 2025

Summary

DJO, LLC is recalling 1,594 Cold Form Back and Shoulder compression wraps because the instructions for use incorrectly tell users to microwave the product for three minutes. This excessive heating can cause the wrap to leak, burst at the seams, or reach extreme temperatures. Affected products include the Shoulder Wrap (REF DP163CT02) and the Back Wrap (REF DP163CT03-BLK-L,XL).

Risk

Heating these wraps according to the incorrect instructions may result in the product leaking or bursting, or reaching temperatures high enough to cause second-degree burns to the user.

What You Should Do

This recall involves DJO Cold Form compression wraps for the shoulder (REF DP163CT02) and back (REF DP163CT03-BLK-L,XL) with specific identification codes.
Immediately stop using the recalled compression wraps in the microwave as instructed by the current labeling.
Identify your product by checking the REF and Lot numbers on the wrap or packaging: Shoulder Wraps (REF DP163CT02) with lots 190523 or 171221, and Back Wraps (REF DP163CT03-BLK-L,XL) with lots 150221 or 180821.
Stop using the product and return it to the place of purchase for a refund or replacement, throw it away, or contact your healthcare provider or DJO, LLC for further instructions.
Call the FDA Consumer Complaint hotline at 1-888-463-6332 for more information about this recall.

Your Remedy Options

You have 2 options:

Option 1: Full Refund

How to: Contact your healthcare provider, or return the product to the place of purchase for a refund or replacement

Option 2: Dispose of Product

How to: Stop using and throw the product away.

Affected Products

Product: Cold Form Wrap: Shoulder

Variants: Shoulder

Model / REF:

DP163CT02

Lot Numbers:

190523

171221

UDI:

00888912164382

REF: DP163CT02

Product: Cold Form Wrap: Back

Variants: Back, L, XL, Black

Model / REF:

DP163CT03-BLK-L,XL

Lot Numbers:

150221

180821

UDI:

00888912164481

REF: DP163CT03-BLK-L,XL

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 97610

Status: Active

Manufacturer: DJO, LLC

Manufactured In: United States

Units Affected: 1,594

Distributed To: Wisconsin, Tennessee, Texas, Maryland, Georgia, Utah, Washington, Michigan, North Carolina, Nebraska, California, Massachusetts, Colorado, South Carolina, Ohio, Indiana, Minnesota, New Mexico, Pennsylvania, New York, Illinois, Florida, New Jersey, Virginia, Arizona, Vermont, Connecticut, Oklahoma

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES · Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.

Summary

What You Should Do

This recall involves DJO Cold Form compression wraps for the shoulder (REF DP163CT02) and back (REF DP163CT03-BLK-L,XL) with specific identification codes.

Immediately stop using the recalled compression wraps in the microwave as instructed by the current labeling.

Identify your product by checking the REF and Lot numbers on the wrap or packaging: Shoulder Wraps (REF DP163CT02) with lots 190523 or 171221, and Back Wraps (REF DP163CT03-BLK-L,XL) with lots 150221 or 180821.

Stop using the product and return it to the place of purchase for a refund or replacement, throw it away, or contact your healthcare provider or DJO, LLC for further instructions.

Call the FDA Consumer Complaint hotline at 1-888-463-6332 for more information about this recall.