FDA recalls Eco-Med ultrasound gels due to bacterial contamination risk
FDA recalls ultrasound gels manufactured by Eco-Med Pharmaceutical due to possible bacterial contamination. Healthcare providers and facilities should stop use immediately.
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 classification mandates a minimum severity of 4 per the recall rubric. Although no illnesses or deaths are reported in the source text, bacterial contamination in medical device ultrasound gels poses a potential health risk to patients and healthcare workers during use.
Plain-English summary
Ultrasound gels and lotions manufactured by Eco-Med Pharmaceutical, Inc. are subject to FDA recall due to potential bacterial contamination. The affected product is EcoGel 200 - RED Medical Supplies Clear Ultrasound Gel, Model No. 250UG-CMU, manufactured between September 23, 2020 and August 8, 2021.
Bacterial contamination in ultrasound gels can pose a health risk if the product comes into contact with skin or other body surfaces during medical procedures. The FDA issued a Letter to Health Care Providers on August 18, 2021, instructing healthcare professionals to cease use of all Eco-Med ultrasound gels and lotions.
The product was sold nationwide domestically through Amazon.com, with approximately 2,000 units distributed. Healthcare facilities, clinics, and individual practitioners who purchased this product should verify their inventory against the affected date codes (September 23, 2020 through August 8, 2021).
Healthcare providers and consumers who have purchased this product should stop using it immediately and contact their supplier or the manufacturer for guidance on safe disposal or return.
The recalled product
- Product
- EcoGel 200 - RED Medical Supplies Clear Ultrasound Gel, Model No. 250UG-CMU
- 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.
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