FDA Recalls Ultrasound Gels for Bacterial Contamination Risk
Omnisound Gel and EcoGel 200 ultrasound gels distributed nationwide from January 2018 to August 2021 may contain bacterial contamination. The FDA issued a Class I recall; health care providers should immediately stop using these 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: FDA Class I classification mandates a minimum severity score of 4 per the rubric. The recall addresses potential bacterial contamination in medical devices without reported illnesses or injuries at time of notice.
Plain-English summary
Omnisound Gel (250 ml bottle and 5 L container) and EcoGel 200 (250 ml bottle) ultrasound gels are being recalled due to potential bacterial contamination. Manufactured by Eco-Med Pharmaceutical, Inc., these products were distributed nationwide from January 1, 2018 through August 4, 2021.
The FDA classified this as a Class I recall due to the potential health risk posed by bacterial contamination in ultrasound gels used in medical procedures. On August 18, 2021, the FDA issued a Letter to Health Care Providers recommending the immediate discontinuation of use for all Eco-Med ultrasound gels and lotions.
Health care providers should immediately stop using any affected products. For more information regarding this recall, contact Accelerated Care Plus Corporation, the recalling firm.
The recalled product
- Product
- Omnisound Gel, 250 ml bottle and 5 L container; and EcoGel 200, 250 ml bottle; Manufactured by Eco-Med. For use in ultrasound procedures.
- Manufacturer
- Accelerated Care Plus Corporation
- 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 (3)
- Distributed from January 1
- 2018 thru August 4
- 2021
Distribution
Distributed nationwide across the United States.
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