The Recall Desk
SevereFDA (Devices)·Z-0068-2022·Announced 2021-10-20

Ultrasound gel products recalled for potential bacterial contamination

Ultrasound gels and lotions manufactured by Eco-Med Pharmaceutical, Inc. may contain bacterial contamination. Products distributed nationwide in the U.S., Canada, and other locations have been recalled.

What this means for you

Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: FDA Class I medical device recall. Although no illnesses or injuries have been reported in the source text, the rubric requires that FDA Class I recalls never score below 4 (Severe).

Plain-English summary

Ultrasound gels and lotions manufactured by Eco-Med Pharmaceutical, Inc. are being recalled because they may contain bacterial contamination. The recalled product is the ECO 50TS Gel Tens Ultrasound, distributed in 1-inch by 5-liter containers.

The affected product (3 units) was distributed nationwide across the United States and internationally to Canada. All lots of product code ECO 50TS are included in this recall.

If you have this product, stop using it and contact National Distribution & Contracting Inc for instructions on how to return or dispose of the recalled product.

The recalled product

Product
ECO 50TS Gel Tens Ultrasound 1in X 5L cube 1 Dispenser Btl
Manufacturer
National Distribution & Contracting Inc
Hazard
  • bacterial-contamination

Distribution

Distributed nationwide across the United States.