Severity
Critical
CriticalClass ITerminated
FDA Devices recall · Reported September 15, 2021
LiquaSonic Ultrasound Gel 5L, Model No. 001222
Ultrasound gels and lotions manufactured by Eco-Med Pharmaceutical, Inc. may contain bacterial contamination. On August 18, 2021, FDA published a Letter to Health Care Providers t…
Compiled from official public sources by the editorial team.
Verify with FDA Devices →
Athena Medical Products Inc recalled LiquaSonic Ultrasound Gel 5L, Model No. 001222 - a critical-severity action.
LiquaSonic Ultrasound Gel 5L, Model No. 001222 was recalled by Athena Medical Products Inc in September 15, 2021. Reason: Ultrasound gels and lotions manufactured by Eco-Med Pharmaceutical, Inc. may contain bacterial contamination.…. Check the official notice for the remedy. Verify recall #Z-2392-2021 with the FDA Devices before acting.
The recall
Athena Medical Products Inc issued this critical-severity FDA Devices recall-Ultrasound gels and lotions manufactured by Eco-Med Pharmaceutical, Inc. may contain bacterial contamination.….
- Critical
- severity level
- Class I
- classification
- September 15, 2021
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-2392-2021 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-2392-2021) was formally reported on September 15, 2021, with the manufacturer initiating the action on August 20, 2021. It is classified under Critical severity (Class I), with a current status of Terminated. Athena Medical Products Inc is listed as the recalling firm, operating out of Cincinnati, OH. Federal records list the affected scope as 480 cases of 4.
The documented reason for this recall is: Ultrasound gels and lotions manufactured by Eco-Med Pharmaceutical, Inc. may contain bacterial contamination. On August 18, 2021, FDA published a Letter to Health Care Providers to further address this issue: https://ww… Distribution data in the federal record shows the product reached: Distributed to one distributor within the US.. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.
Within the same product category the archive holds 6 closely related recalls, 6 from FDA Devices - clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.
Medical Devices recalls over time
Where this recall sits in its category - 40,409 medical devices recalls on record
Where this recall sits in the database
Of 100,165 recalls in the database, 23,668 are high severity, 72,097 moderate, and 4,400 low. This recall is classified high severity.
Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.
Affected scope
480 cases of 4
Related Recalls
6
6 from same agency
Product description
LiquaSonic Ultrasound Gel 5L, Model No. 001222
Reason for recall
Ultrasound gels and lotions manufactured by Eco-Med Pharmaceutical, Inc. may contain bacterial contamination. On August 18, 2021, FDA published a Letter to Health Care Providers to further address this issue: https://www.fda.gov/medical-devices/letters-health-care-providers/stop-using-all-eco-med-ultrasound-gels-and-lotions-due-risk-bacterial-contamination-letter-health.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Critical (Class I) |
| Status | Terminated |
| Recall number | Z-2392-2021 |
| Date reported | September 15, 2021 |
| Date initiated | August 20, 2021 |
| Recalling firm | Athena Medical Products Inc |
| Firm location | Cincinnati, OH |
| Affected scope | 480 cases of 4 |
| Distribution | Distributed to one distributor within the US. |
Profile values are sourced directly from the official FDA Devices enforcement record. Source: U.S. Food and Drug Administration.
What to do with this recall
Match your product against the recall record, then act on the agency remedy.
- Check the recall number (Z-2392-2021) and product description against the item you own. Search the archive
- Confirm the current status with FDA Devices before acting, recall details can be updated.
- This is a Class I (high-risk) recall, stop using the product immediately and follow the disposal or return instructions. What to do next
This page summarizes the official FDA Devices record for research and awareness; it is not legal, medical, or safety advice. Verify with the issuing agency before acting.
Frequently Asked Questions
What product was recalled? ▼
LiquaSonic Ultrasound Gel 5L, Model No. 001222. Recalled by Athena Medical Products Inc. Units affected: 480 cases of 4.
Why was this product recalled? ▼
Ultrasound gels and lotions manufactured by Eco-Med Pharmaceutical, Inc. may contain bacterial contamination. On August 18, 2021, FDA published a Letter to Health Care Providers to further address this issue: https://www.fda.gov/medical-devices/letters-health-care-providers/stop-using-all-eco-med-ultrasound-gels-and-lotions-due-risk-bacterial-contamination-letter-health.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on September 15, 2021. Severity: Critical. Recall number: Z-2392-2021.
Where was the recalled product distributed? ▼
Distribution: Distributed to one distributor within the US..
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-2392-2021) against your product. Visit the official FDA Devices website for the most current information. You can also use our Recall Checker tool to search by product name or brand.
Should I stop using a recalled medication or medical device? ▼
Do not stop using a recalled medication or device without consulting your healthcare provider first, as abruptly discontinuing treatment could pose its own health risks. Your doctor can advise on alternatives or whether the recall applies to your specific product lot. Check the recall number and lot information against your product packaging.
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Data Sources
Source: FDA, CPSC, and NHTSA federal recall databases. This recall: FDA Devices, reported September 15, 2021.
- Source: FDA - Food and Drug Administration, openFDA Enforcement API (food, drug, and medical device recalls)
- Source: CPSC - Consumer Product Safety Commission Recalls API (consumer product recalls and hazards)
- Source: NHTSA - National Highway Traffic Safety Administration Recalls API (vehicle safety recalls)
Recall information is sourced from official federal agency databases. Always verify recall details with the issuing agency for the most current status. This information is for research and awareness purposes only.
Every figure on PlainRecalls is rendered directly from official FDA, CPSC and NHTSA recall records, no number is typed in by an editor. Severity classes follow each agency's own taxonomy (FDA Class I/II/III; CPSC and NHTSA by hazard type), and related-recall context is computed across the full archive. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of June 2026.