Eco-Med Ultrasound Gel Recalled for Bacterial Contamination Risk
Eco-Med Pharmaceutical's ultrasound gel products are recalled due to potential bacterial contamination. The FDA advises healthcare providers to stop using the affected product.
The agency’s classification
FDA (Devices): Class I
Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: This is an FDA Class I recall, requiring a minimum severity score of 4. Although no illnesses or injuries are reported in the source text, bacterial contamination in a medical device presents a significant risk of harm.
Plain-English summary
Eco-Med Pharmaceutical, Inc. manufactured the EcoGel 200 - RED Medical Supplies Blue Ultrasound Gel (Model No. 250UG-BMU), which may contain bacterial contamination. Approximately 3,000 units were distributed domestically through Amazon.com. The affected product was manufactured between September 23, 2020, and August 8, 2021.
The FDA issued a letter to healthcare providers on August 18, 2021, advising discontinuation of all Eco-Med ultrasound gels and lotions due to the risk of bacterial contamination. Healthcare providers and consumers who possess this product should stop using it immediately.
The recalled product
- Product
- EcoGel 200 - RED Medical Supplies Blue Ultrasound Gel, Model No. 250UG-BMU
- Manufacturer
- Red Medical Supplies
- Category
- Medical Device
- Hazard
- Affected units
- 3,000
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.
Part of a larger recall action
This product is one of 3 recalled by Red Medical Supplies under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 3 products in this recall →Related recalls
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