O-Two Medical Technologies, Inc.: Medical Device Recall in 2017 - (Recall #: Z-2731-2017)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2017.

Data Source: FDA.

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.

Product Classification:

Class II

Date Initiated: September 30, 2015

Date Posted: July 19, 2017

Recall Number: Z-2731-2017

Event ID: 77534

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. .

Status: Terminated

Product Quantity: 624 units

Code Information:

Lot/Batch#1150, 1152, 5210; Expiration date: Jul.2018 (for lot 5210), July 2020 (for lot 1150, 1152)

Distribution Pattern:

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

Voluntary or Mandated:

Voluntary: Firm initiated