The Recall Desk
CriticalFDA (Devices)·Z-2392-2021·Announced 2021-09-15

Eco-Med ultrasound gels and lotions recalled for bacterial contamination

Ultrasound gels and lotions manufactured by Eco-Med Pharmaceutical, Inc. are being recalled due to potential bacterial contamination. The FDA issued a Class I recall on August 18, 2021, advising health care providers to stop using all affected products.

What this means for you

Highest-severity recall. Risk of serious injury or death is documented or strongly suspected. Stop using the product now and follow the agency's instructions.

Our severity reasoning: FDA Class I recall. Per the severity rubric, FDA Class I recalls are classified as Critical (score 5), the highest severity level.

Plain-English summary

Eco-Med Pharmaceutical, Inc. has recalled all ultrasound gels and lotions due to potential bacterial contamination. The FDA classified this as a Class I recall and on August 18, 2021, issued a Letter to Health Care Providers instructing immediate cessation of use of all Eco-Med ultrasound gels and lotions.

Bacterial contamination in ultrasound gels poses a risk of infection, particularly when used in clinical settings. Health care providers and patients using these products should discontinue use immediately. The FDA's letter to health care providers contains guidance on proper inventory handling and patient notification procedures.

The recalled product

Product
LiquaSonic Ultrasound Gel 5L, Model No. 001222
Manufacturer
Athena Medical Products Inc
Hazard
  • bacterial-contamination

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (2)

  • UDI 00856589006137
  • All lot codes. Product will be discontinued and will not be reintroduced.

Distribution

Distribution scope not specified by the agency.