# FDA recall Z-2731-2017

> **O-Two Medical Technologies, Inc.** · Class II · device recall initiated 2015-09-30.

## Product

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.

## Reason for recall

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.   .

## Distribution

Worldwide Distribution - US (nationwide) Canada,  Belgium, Norway, and Malaysia

## Key facts

- **Recall number:** Z-2731-2017
- **Recalling firm:** O-Two Medical Technologies, Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2015-09-30
- **Report date:** 2017-07-19
- **Termination date:** 2017-09-01

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Mississauga, Canada

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2731-2017

## Citation

> AI Analytics. FDA recall Z-2731-2017. Retrieved 2026-06-25 from https://api.ai-analytics.org/recall/Z-2731-2017. Source: US FDA. Licensed CC0.

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