The Recall Desk
SevereFDA (Devices)·Z-0029-2022·Announced 2021-10-13

Eco-Med Ultrasound Gels and Lotions Recalled for Bacterial Contamination

Eco-Med Pharmaceutical's ultrasound gels and lotions are recalled for potential bacterial contamination. The FDA advises health care providers to stop using all affected products.

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: This is an FDA Class I recall. Although no illnesses or injuries have been reported in the source text, the FDA Class I classification indicates serious potential health consequences, requiring a minimum score of 4 per the rubric.

Plain-English summary

Ultrasound gels and lotions manufactured by Eco-Med Pharmaceutical, Inc. have been recalled due to potential bacterial contamination.

The FDA issued guidance on August 18, 2021, advising health care providers to discontinue use of all Eco-Med ultrasound gels and lotions.

Health care providers in possession of Eco-Med ultrasound gels or lotions should stop using these products.

The recalled product

Product
Action De Gala, FuSion Conductive Gel - Product Usage: Intended for use in acoustic coupling of ultrasound transducer to tissue.
Manufacturer
Aesthetics Systems Usa Inc
Category
Medical Device — Ultrasound Gel
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 (1)

  • All lots with valid expiration dates

Distribution

Distributed nationwide across the United States.

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