The Recall Desk
SevereFDA (Devices)·Z-0090-2022·Announced 2021-10-20

FDA Recalls Ultrasound Gel for Possible Bacterial Contamination

Red Medical Supplies is recalling EcoGel 100 ultrasound gel due to possible bacterial contamination. Approximately 639 units were sold nationwide through Amazon.com.

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, which the rubric classifies as at minimum Severe (4). No deaths or serious injuries have been reported in the source material, so the classification does not meet the criteria for Critical (5).

Plain-English summary

Red Medical Supplies is recalling EcoGel 100 - RED Medical Supplies Green Ultrasound Gel, Model No. 250UG-GLU, due to possible bacterial contamination in the product. The gel manufactured by Eco-Med Pharmaceutical, Inc. between September 23, 2020, and August 8, 2021, may contain bacterial contamination.

Approximately 639 units of the affected product were distributed to customers nationwide through Amazon.com. Healthcare providers and facilities in possession of this product should discontinue use immediately. The FDA issued a Letter to Health Care Providers on August 18, 2021, recommending the cessation of use of all Eco-Med ultrasound gels and lotions due to the risk of bacterial contamination.

The recalled product

Product
EcoGel 100 - RED Medical Supplies Green Ultrasound Gel, Model No. 250UG-GLU
Manufacturer
Red Medical Supplies
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 product manufactured by Eco-Med between 2020.09.23 - 2021.08.08

Distribution

Distributed nationwide across the United States.

Related recalls

Same category