The FDA has identified this as a Class I recall, the most serious type of recall. Use of these devices may cause serious injuries or death.

Recalled Product

• Product Names: ultrasound gel products and lotions manufactured by Eco-Med are marketed by a number of distributors, under different product names, which include but are not limited to the following:

• Product Codes: MUI, ITX, GYB
• Manufacturing Years: 2018 until Present
• Distribution Years: 2018 until Present
• Date Initiated by Manufacturer: August 4, 2021

Eco-Med has shut down all operations and is no longer manufacturing or distributing any products.

Device Use

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 a clear, water-based gel that is applied to the skin on the area to be examined. The gel helps with the transmission of sound waves.

Reason for Recall

All ultrasound gels and lotions manufactured by Eco-Med are being recalled due to risk of bacterial contamination with Burkholderia cepacia complex (Bcc). The FDA independently confirmed that distributed product tested positive for bacterial contamination. 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).

Who May be Affected

• Health care providers who use ultrasound gels and lotions manufactured by Eco-Med Pharmaceutical, Inc., and distributed by multiple entities under various product names.
• Patients who require care using ultrasound gels or lotions manufactured by Eco-Med Pharmaceutical, Inc., and distributed by multiple entities under various product names.

What to Do

On Aug. 4, 2021, Eco-Med Pharmaceutical, Inc. 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 health care 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 (see Additional Resources).
• Contact the distributor that supplied these products to you if you have questions about the disposal of the products.
• Report any adverse reactions or quality problems experienced with the use of these products to the FDA's MedWatch Adverse Event Reporting program.

Contact Information

Customers in the U.S. with questions about this recall should contact the distributor who supplied the affected products.

Eco-Med has shut down all operations and is no longer manufacturing or distributing any products.

Full List of Affected Devices

Please see Medical Device Recall Database Entry below.

Additional Resources:

1. Medical Device Recall Database Entry
2. Stop Using All Eco-Med Ultrasound Gels and Lotions Due to Risk of Bacterial Contamination – Letter to Health Care Providers
3. Eco-Med Pharmaceutical, Inc. Recall Letter
4. Eco-Med Pharmaceutical, Inc. Recall Web Page
5. Related FDA recall classification notice

How do I report a problem?

Health care professionals and consumers may report adverse reactions or quality problems they experienced using these devices to MedWatch: The FDA Safety Information and Adverse Event Reporting Program using an online form, regular mail, or FAX.