FDA Recall: All ultrasound gels and lotions by Eco-Med Pharmaceutical

Nov. 24, 2021

All ultrasound gels and lotions manufactured by Eco-Med are being recalled due to risk of bacterial contamination with Burkholderia cepacia complex (Bcc). The use of affected ultrasound gels and lotions contaminated with Bcc may lead to serious infections, including bloodstream infections, which may result in sepsis or death.

As of Aug. 31, 2021, there have been at least 66 infections, including 60 bloodstream infections associated with these affected products, per the Centers for Disease Control and Prevention (CDC).

Eco-Med ultrasound gels and lotions are used during an ultrasound test to create images of organs and structures inside the body. Ultrasound gel is applied to the skin on the area to be examined to help with the transmission of sound waves.

In August, Eco-Med Pharmaceutical sent a recall classification notice for certain lots of EcoGel, MediChoice, and Mac Medical ultrasound gel. However, the FDA has determined that all ultrasound gels and lotions manufactured by Eco-Med are at risk for bacterial contamination.

The FDA recommends healthcare providers and facilities:

  • Immediately stop using and discard all ultrasound gel and lotion products manufactured by Eco-Med.
  • Do not purchase ultrasound gels or lotions manufactured by Eco-Med.
  • Consult Centers for Disease Control and Prevention (CDC) and professional society guidelines regarding use of ultrasound gel and appropriate ultrasound cleaning procedures.
  • Contact the distributor that supplied these products to you if you have questions about the disposal of the products.

FDA press release