The Recall Desk
SevereFDA (Devices)·Z-0009-2022·Announced 2021-10-13

Ultrasound gel distributed with medical devices recalled for bacterial contamination

Ultrasound gel manufactured by Eco-Med Pharmaceutical and distributed with various medical device kits may contain bacterial contamination. Users should stop using affected products and follow FDA guidance.

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 recall for potential bacterial contamination in ultrasound gel. Although no illnesses or injuries have been reported, the FDA's own highest-level classification (Class I) requires a minimum severity rating of Severe per the rubric.

Plain-English summary

DJO, LLC is recalling GEL CONDUCTOR ultrasound gel manufactured by Eco-Med Pharmaceutical, Inc. The recalled products include gel in 5-liter containers with dispensers, 24-packs of 8.5-ounce bottles, and 5-liter bulk sizes. These gels are distributed as components of ultrasound therapy device kits sold under various brand names including Intelect, Vectra, Senior Solutions, Legend XT, and others.

The gels may contain bacterial contamination. The FDA issued guidance on August 18, 2021, recommending that healthcare providers stop using all affected ultrasound gels and lotions manufactured by Eco-Med.

The affected products have been distributed nationwide across all U.S. states as well as internationally to France, China, Mexico, Ontario, Australia, and other countries. Approximately 67,485 units were distributed.

Healthcare providers and patients who have these products should discontinue use immediately and follow the FDA's complete guidance on managing this recall.

The recalled product

Product
GEL CONDUCTOR, Description/REF: 5 LITER W/DISP/4238, 24-8.5OZ BOTTLES/4248, 5 LITER/4266, distributed by DJO, LLC / DJO FRANCE in the following kits, Part/Description: 2073/ INTELECT RPW 120V, 2073-BR/ INTELECT RPW 120V BRAZIL, 2074/ INTELECT RPW 230 V, 20
Manufacturer
DJO, LLC
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)

  • All Lots Manufactured by Eco-Med Pharmaceutical
  • Inc

Distribution

Distributed nationwide across the United States.