Recalls for Pad, Heating, Powered

If heating pad is folded while in use, the power density increases in the folded area causing excessive temperatures, which can also be caused by placing pad under the body, then the high limit device is unable to sense the higher temperature so power is not terminated. May cause a burning smell prior to melting/burning potentially causing burns to persons and property.

Due to a change in the safety clips for the heated eye masks, the wires to the safety clips may detach as a result of tugging and pulling and may cause a short in the heating element of the mask and could potentially cause burn injuries.

The products may have the potential to burn customers. Firm has received complaints of burns, mild shocks, and rashes/irritation.

The products may have the potential to burn customers. Firm has received complaints of burns, mild shocks, and rashes/irritation.

The products may have the potential to burn customers. Firm has received complaints of burns, mild shocks, and rashes/irritation.

Heating pads may have a loose electrical connection, which could result in excessive heat being generated that poses a risk of patient burns, fire, and property damage.

Heating pads may have a loose electrical connection, which could result in excessive heat being generated that poses a risk of patient burns, fire, and property damage.

Heating pads may have a loose electrical connection, which could result in excessive heat being generated that poses a risk of patient burns, fire, and property damage.

Heating pads may have a loose electrical connection, which could result in excessive heat being generated that poses a risk of patient burns, fire, and property damage.

Heating pads may have a loose electrical connection, which could result in excessive heat being generated that poses a risk of patient burns, fire, and property damage.

Products manufactured with the SPT cord have a known failure mode of sparking,causing smoke, fire and burns.

During an FDA inspection it was found that the firm claims unapproved therapy and medical claims on product information and website.

During an FDA inspection it was found that the firm claims unapproved therapy and medical claims on product information and website.

During an FDA inspection it was found that the firm claims unapproved therapy and medical claims on product information and website.

During an FDA inspection it was found that the firm claims unapproved therapy and medical claims on product information and website.

During an FDA inspection it was found that the firm claims unapproved therapy and medical claims on product information and website.

During an FDA inspection it was found that the firm claims unapproved therapy and medical claims on product information and website.

During an FDA inspection it was found that the firm claims unapproved therapy and medical claims on product information and website.

During an FDA inspection it was found that the firm claims unapproved therapy and medical claims on product information and website.

During an FDA inspection it was found that the firm claims unapproved therapy and medical claims on product information and website.

During an FDA inspection it was found that the firm claims unapproved therapy and medical claims on product information and website.

During an FDA inspection it was found that the firm claims unapproved therapy and medical claims on product information and website.

During an FDA inspection it was found that the firm claims unapproved therapy and medical claims on product information and website.

Products are marketed without a cleared 510k.