Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Burn Relief¿ Recalled by O-Two Medical Technologies, Inc. Due to For lack of evidence to validate effectiveness of...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact O-Two Medical Technologies, Inc. directly.
Affected Products
Burn Relief¿, MODEL #(s): 06BK1221, 06BK1232, 06BK1201, 06BK1200, CATALOG #(s): 06BK1221, 06BK1232, 06BK1201, 06BK1200 --- DRESSING,WOUND,HYDROGEL W/OUT DRUG AND/OR BIOLOGIC. --- Burn Relief¿ products are self-cooling, non-adhering and are intended to be used on 1st and 2nd degree burns.
Quantity: 624 units
Why Was This Recalled?
For lack of evidence to validate effectiveness of sterilization dose, O-Two Medical Technologies Inc. hereby announces a voluntary medical device recall of the suspected batches of Burn Relief¿ products to prevent potential contamination. .
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About O-Two Medical Technologies, Inc.
O-Two Medical Technologies, Inc. has 6 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report