FDA Medical Device Recalls (openFDA)
Athena Medical Products Inc: LiquaSonic Ultrasound Gel 250mL, Model No. 001205
- Recall number
- Z-2391-2021
- Recalling firm
- Athena Medical Products Inc
- Product
- LiquaSonic Ultrasound Gel 250mL, Model No. 001205
- Status
- Terminated
- Initiated
- 2021-08-20
- Posted
- 2021-09-09
- Terminated
- 2023-02-02
- 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 August 20, 2021, the firm issued an Urgent Medical Device Recall letter to its only customer, who is a distributor. The letter explained the product issue and asked that the distributor identify their customers and notify them at once of the product recall. ALL lots of product should be returned or destroyed. Athena will no longer purchase or distribute products manufactured by Eco-Med. If you or your customers have any questions you can call the Recall Coordinator at 888-216-7307 or email athena8649@stericycle.com.
- Quantity
- 12,240 cases of 12
- Distribution
- Distributed to one distributor within the US.
- Lot, serial or model codes
- UDI 00856589006120, All lot codes. Product will be discontinued and will not be reintroduced.
- 510(k) numbers
- ["K955246"]
- PMA numbers
- not on file
- Product code
- ITX
- Firm FEI
- 3012175629
- Firm city
- Cincinnati
- Firm state
- OH
- 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