Burn Relief¿ — Class II medical device recall Z-2731-2017
Terminated recall by O-Two Medical Technologies, Inc., reported 2017-07-19, distributed nationwide. For lack of evidence to validate effectiveness of sterilization dose, O-Two Medical Technologies Inc. hereby a
| Recall number | Z-2731-2017 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | O-Two Medical Technologies, Inc., Mississauga, Canada |
| Recall initiated | 2015-09-30 |
| Classified | 2017-07-13 |
| Reported by FDA | 2017-07-19 |
| Terminated | 2017-09-01 |
| Distributed | Nationwide (US) |
| Countries outside the US | BE, CA, MY, NO |
| Quantity | 624 units |
| Lot numbers | 1150, 1152, 5210 |
| Model numbers | 06BK1200, 06BK1201, 06BK1221, 06BK1232 |
| Expiration dates | 2018-07-20 |
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. .
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2731-2017. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.