Class II — O-Two Medical Technologies, Inc.
| Recalling firm | O-TWO MEDICAL TECHNOLOGIES, INC. |
|---|---|
| Registered facility | O-TWO MEDICAL TECHNOLOGIES, INC. (the firm's only registered facility) |
| Classification | Class II |
| Status | Terminated |
| Reason | 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. . |
| 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. |
| Quantity | 624 units |
| Distribution | Worldwide Distribution - US (nationwide) Canada, Belgium, Norway, and Malaysia |
| Initiated | 2015-09-30 |
| Classified | 2017-07-13 |
| Terminated | 2017-09-01 |
| Recall number | Z-2731-2017 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — O-Two Medical Technologies, Inc. (Z-2731-2017).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/77534/
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