FDA Medical Device Recalls (openFDA)
Accelerated Care Plus Corporation: Omnisound Gel, 250 ml bottle and 5 L container; and EcoGel 200, 250 ml bottle; Manufactured by Eco-Med. For use in ultrasound procedures.
- Recall number
- Z-2518-2021
- Recalling firm
- Accelerated Care Plus Corporation
- 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.
- Status
- Open, Classified
- Initiated
- 2021-08-25
- Posted
- not on file
- Terminated
- not on file
- Reason
- 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
- 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
- 9436
- Distribution
- US nationwide distribution.
- Lot, serial or model codes
- Distributed from January 1, 2018 thru August 4, 2021
- 510(k) numbers
- ["K955246"]
- PMA numbers
- not on file
- Product code
- ITX
- Firm FEI
- 1000119345
- Firm city
- Reno
- Firm state
- NV
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28