FDA Recalls Ultrasound Gels and Lotions for Potential Bacterial Contamination
Ultrasound gels and lotions manufactured by Eco-Med Pharmaceutical may contain bacterial contamination. The FDA has issued a Class I recall affecting 8,702 units distributed worldwide.
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. Per the severity rubric, FDA Class I recalls have a minimum severity score of 4 (Severe). Although no illnesses or deaths have been reported, the agency's classification reflects the serious potential for patient harm from bacterial contamination in medical devices used directly on patients.
Plain-English summary
DJO, LLC is recalling Ultra-Myossage Lotion and Myossage Lotion products (1-gallon bottles) because they may contain bacterial contamination. All affected products were manufactured by Eco-Med Pharmaceutical, Inc.
The contamination poses a health risk to patients who use these lotions with ultrasound equipment. On August 18, 2021, the FDA published a Letter to Health Care Providers directing healthcare providers to stop using all Eco-Med ultrasound gels and lotions due to the risk of bacterial contamination.
Approximately 8,702 units have been distributed worldwide, including to facilities in the United States, France, China, Mexico, Ontario, Australia, and other locations. Healthcare facilities and medical professionals should immediately cease using any affected products and contact DJO, LLC or the FDA with questions.
The recalled product
- Product
- Ultra-Myossage Lotion 1-gallon bottle, REF: 4262; Myossage Lotion 1-gallon bottle, REF: 4210, located in the following DJO, LLC / DJO FRANCE kits:
- Manufacturer
- DJO, LLC
- Hazard
- Affected units
- 8,702
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
Part of a larger recall action
This product is one of 2 recalled by DJO, LLC 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.
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