Z-2731-2017Class II

Burn Relief, MODEL #(s): 06BK1221, 06BK1232, 06BK1201, 06BK1200, CATALOG #(s): 06BK1221, 06BK1232, 06BK1201...

Name: Z-2731-2017 Burn Relief, MODEL #(s): 06BK1221, 06BK1232, 06BK1201, 06BK1200, CATALOG #(s): 06BK1221, 06BK1232, 06BK1201...
Creator: O-Two Medical Technologies, Inc.
Published: 2015-09-30
License: https://open.fda.gov/license/

O-Two Medical Technologies, Inc. / initiated 2015-09-30 / Terminated / root cause: manufacturing process

FDA source

O-Two Medical Technologies, Inc. began a recall of Burn Relief, MODEL #(s): 06BK1221, 06BK1232, 06BK1201, 06BK1200, CATALOG #(s): 06BK1221, 06BK1232, 06BK1201, 06BK1200 --- DRESSING,WOUND,HYDROGEL W/OUT DRUG... on 2015-09-30. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-2731-2017
Classification: Class II
Status: Terminated
Initiated: 2015-09-30
Posted: 2017-06-22
Terminated: 2017-09-01
Recalling firm: O-Two Medical Technologies, Inc.
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.
Product code: NAE Dressing, Wound, Hydrogel Without Drug And/Or Biologic
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. .
Root cause tag: manufacturing process
FDA root cause: Process control
Action: O-Two sent a Voluntary Recall Notification dated September 30, 2015, to all affected customers. Customers were instructed to acknowledge receipt of the recall notice by fax to 1-905-677-2035; or email to [email protected]. Customers with questions should call 1-905-677-9410. For questions regarding this recall call 905-677-9410 .
Quantity in commerce: 624 units
Distribution: Worldwide Distribution - US (nationwide) Canada, Belgium, Norway, and Malaysia
Product codes and lots: Lot/Batch#1150, 1152, 5210; Expiration date: Jul.2018 (for lot 5210), July 2020 (for lot 1150, 1152)

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2731-2017
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2731-2017	Class II	Terminated	Voluntary: Firm initiated	2017-07-19	2017-07-13

Product code NAE

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)