Multiple Ultrasound Gel Products Recalled for Potential Bacterial Contamination
Ultrasound gels sold under multiple brand names have been recalled due to potential bacterial contamination. Approximately 100,114 units distributed nationwide between August 2018 and August 2021 are affected.
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: The FDA classified this recall as Class I, indicating a reasonable probability of serious adverse health consequences from bacterial contamination. No illnesses or injuries have been reported to date, but the agency's formal Class I determination reflects the inherent risk posed by microbial contamination in medical devices.
Plain-English summary
The U.S. Food and Drug Administration has recalled ultrasound gel products sold under the following brand names: MediChoice Ultrasound Gel, Athena Liquasonic Ultrasound Gel, Eco-Med EcoGel Ultrasound Gel, MAC Medical Supply Ultrasound Gel, Eco-Med EcoGel 200 Blue High Velocity Ultrasound Gel, and Eco-Med EcoGel 200 Multi-Purpose Ultrasound Gel. Approximately 100,114 units were distributed nationwide between August 2018 and August 2021 in various package sizes and formulations.
The recall was initiated because the products may contain bacterial contamination. The FDA has classified this as a Class I recall, indicating the agency has determined there is a reasonable probability that use of a contaminated product could result in serious adverse health consequences.
Healthcare facilities and individuals who have ultrasound gels from the affected product lines and lot codes should discontinue use immediately. The specific item numbers and lot information are available in the FDA's official recall notice (Z-2469-2021).
Consumers and healthcare providers should contact their distributor or the manufacturer for instructions on product returns, destruction, or replacement. Anyone who has concerns about potential exposure should consult their healthcare provider.
The recalled product
- Product
- Ultrasound Gel labeled under the following brand names: MediChoice Ultrasound Gel, Athena Liquasonic Ultrasound Gel, Eco-Med EcoGel Ultrasound Gel, MAC Medical Supply Ultrasound Gel, Eco-Med EcoGel 200 Blue High Velocity Ultrasound Gel, Eco-Med EcoGel 200 Multi-Purpose…
- Manufacturer
- Mac Medical Supply Co Inc
- Hazard
- Affected units
- 100,114
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 (13)
- Item Numbers: 1) 001205 (LiquaSonic Ultrasound Gel
- 8.5oz) 2) 001222 (LiquaSonic Ultrasound Gel
- 5L) 3) 30GB (EcoGel 100
- 250ml
- 12/cs) 4) 5005L4 (MAC EcoGel 5L
- 4/cs) 5) 500812 (MAC EcoGel
- 12/cs) 6) M50008 (MediChoice Empty 8oz bottle) 7) M5005L4 (MediChoice USG 5L
- 4/cs) 8) M500812 (MediChoice
- 12/cs) 9) 50TB (EcoGel High V TENS
- 250ml) 10) 40JBB (EcoGel Multipurpose Ultrasound Gel
- 8oz
- 12/cs) 11) 40JBHV-24 (EcoGel Blue High Velocity Ultrasound Gel
- 5L
Distribution
Distributed nationwide across the United States.
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