FDA Recalls Ultrasound Gel for Risk of Bacterial Contamination
Ultrasound gels and lotions manufactured by Eco-Med Pharmaceutical, Inc. are being recalled due to the risk of bacterial contamination. Healthcare providers and consumers should stop using affected products.
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: FDA Class I classification requires a minimum severity score of 4. Bacterial contamination of a medical device intended for patient contact presents significant risk, even absent reported illnesses to date.
Plain-English summary
Athena Medical Products Inc. is recalling LiquaSonic Ultrasound Gel 250mL (Model No. 001205) manufactured by Eco-Med Pharmaceutical, Inc. because it may contain bacterial contamination. The recalled product was distributed to one distributor within the United States, with an affected quantity of 12,240 cases of 12 units. All lot codes of this product are included in the recall.
On August 18, 2021, the FDA published a Letter to Health Care Providers addressing this issue and instructing health care providers to stop using all Eco-Med ultrasound gels and lotions due to the risk of bacterial contamination.
Healthcare facilities and individuals currently using this product should discontinue use immediately and follow guidance from the FDA and their healthcare providers. The manufacturer has discontinued this product and will not reintroduce it.
The recalled product
- Product
- LiquaSonic Ultrasound Gel 250mL, Model No. 001205
- Manufacturer
- Athena Medical Products Inc
- Category
- Medical Device — Ultrasound
- Hazard
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)
- UDI 00856589006120
- All lot codes. Product will be discontinued and will not be reintroduced.
Distribution
Distribution scope not specified by the agency.
Part of a larger recall action
This product is one of 2 recalled by Athena Medical Products Inc 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 2 products in this recall →Related recalls
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