Z-2518-2021Class I

Omnisound Gel, 250 ml bottle and 5 L container; and EcoGel 200, 250 ml bottle; Manufactured by Eco-Med. For...

Name: Z-2518-2021 Omnisound Gel, 250 ml bottle and 5 L container; and EcoGel 200, 250 ml bottle; Manufactured by Eco-Med. For...
Creator: Accelerated Care Plus Corporation
Published: 2021-08-25
License: https://open.fda.gov/license/

Accelerated Care Plus Corp. / initiated 2021-08-25 / Open, Classified / root cause: manufacturing process

FDA source

Accelerated Care Plus Corporation began a recall of Omnisound Gel, 250 ml bottle and 5 L container; and EcoGel 200, 250 ml bottle; Manufactured by Eco-Med. For use in ultrasound procedures on 2021-08-25. FDA classified it as Class I and gives the reason as "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...". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-2518-2021
Classification: Class I
Status: Open, Classified
Initiated: 2021-08-25
Posted: 2021-09-25
Recalling firm: Accelerated Care Plus Corp.
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.
Product code: ITX Transducer, Ultrasonic, Diagnostic
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
Root cause tag: manufacturing process
FDA root cause: Process control
Action: On 08/25/2021, Medical Device Recall notices were mailed and emailed to customers who were asked to take the following actions: Immediately stop use of all Eco-Med products. - Destroy and render unusable all affected products that you received from ACPL, by disposing the gel along with your general medical waste. - Carefully read the Recall Notice and follow the instructions, including completing the Eco-Med Product Recall Response Form indicating that you have read the recall notice and will take appropriate action including documenting the quantity of product in inventory and the quantity destroyed. - If you have further distributed this product, please identify your customers, and notify them at once of this product recall by sharing this recall notification letter. Customers with additional questions or concerns can call Customer Support at 800.350.1100.
Quantity in commerce: 9436
Distribution: US nationwide distribution.
Product codes and lots: Distributed from January 1, 2018 thru August 4, 2021

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2518-2021
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2518-2021	Class I	Ongoing	Voluntary: Firm initiated	2021-10-06	2021-09-24

Product code ITX

K955246Class IIEcogel 200 Ultrasound GelEco-Med Pharmaceuticals, Inc. / cleared 1996-02-21

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)