Severity
Moderate
ModerateClass IITerminated
FDA Devices recall · Reported July 19, 2017
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.
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 …
Compiled from official public sources by the editorial team.
Verify with FDA Devices →
O-Two Medical Technologies, Inc. recalled Burn Relief¿, MODEL #(s): 06BK1221, 06BK1232, 06BK1201, 06BK1200, CATALOG #(s): 06BK1221,… - a moderate-severity action.
Burn Relief¿, MODEL #(s): 06BK1221, 06BK1232, 06BK1201, 06BK1200, CATALOG #(s): 06BK1221,… was recalled by O-Two Medical Technologies, Inc. in July 19, 2017. Reason: For lack of evidence to validate effectiveness of sterilization dose, O-Two Medical Technologies Inc. hereby …. Check the official notice for the remedy. Verify recall #Z-2731-2017 with the FDA Devices before acting.
The recall
O-Two Medical Technologies, Inc. issued this moderate-severity FDA Devices recall-For lack of evidence to validate effectiveness of sterilization dose, O-Two Medical Technologies Inc. hereby ….
- Moderate
- severity level
- 624 units
- affected scope
- Class II
- classification
- July 19, 2017
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-2731-2017 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-2731-2017) was formally reported on July 19, 2017, with the manufacturer initiating the action on September 30, 2015. It is classified under Moderate severity (Class II), with a current status of Terminated. O-Two Medical Technologies, Inc. is listed as the recalling firm, operating out of Mississauga. Federal records list the affected scope as 624 units.
The documented reason for this recall is: 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 pote… Distribution data in the federal record shows the product reached: Worldwide Distribution - US (nationwide) Canada, Belgium, Norway, and Malaysia. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.
Within the same product category the archive holds 6 closely related recalls - clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.
Medical Devices recalls over time
Where this recall sits in its category - 40,422 medical devices recalls on record
Of 101,704 recalls in the database, 24,878 are high severity, 72,426 moderate, and 4,400 low. This recall is classified moderate severity.
Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.
Affected scope
624 units
Related Recalls
6
0 from same agency
Product description
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. .
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Terminated |
| Recall number | Z-2731-2017 |
| Date reported | July 19, 2017 |
| Date initiated | September 30, 2015 |
| Recalling firm | O-Two Medical Technologies, Inc. |
| Firm location | Mississauga |
| Affected scope | 624 units |
| Distribution | Worldwide Distribution - US (nationwide) Canada, Belgium, Norway, and Malaysia |
Profile values are sourced directly from the official FDA Devices enforcement record. Source: U.S. Food and Drug Administration.
What to do with this recall
Match your product against the recall record, then act on the agency remedy.
- Check the recall number (Z-2731-2017) and product description against the item you own. Search the archive
- Confirm the current status with FDA Devices before acting, recall details can be updated.
- Follow the documented remedy (refund, replacement, repair, or disposal) rather than general advice. What to do next
This page summarizes the official FDA Devices record for research and awareness; it is not legal, medical, or safety advice. Verify with the issuing agency before acting.
Frequently Asked Questions
What product was recalled? ▼
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.. Recalled by O-Two Medical Technologies, Inc.. Units affected: 624 units.
Why was this product 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. .
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on July 19, 2017. Severity: Moderate. Recall number: Z-2731-2017.
Where was the recalled product distributed? ▼
Distribution: Worldwide Distribution - US (nationwide) Canada, Belgium, Norway, and Malaysia.
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-2731-2017) against your product. Visit the official FDA Devices website for the most current information. You can also use our Recall Checker tool to search by product name or brand.
Should I stop using a recalled medication or medical device? ▼
Do not stop using a recalled medication or device without consulting your healthcare provider first, as abruptly discontinuing treatment could pose its own health risks. Your doctor can advise on alternatives or whether the recall applies to your specific product lot. Check the recall number and lot information against your product packaging.
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Every figure on PlainRecalls is rendered directly from official FDA, CPSC and NHTSA recall records, no number is typed in by an editor. This recall: FDA Devices, reported July 19, 2017. Severity classes follow each agency's own taxonomy (FDA Class I/II/III; CPSC and NHTSA by hazard type), and related-recall context is computed across the full archive. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of July 2026.