FDA Medical Device Recalls (openFDA)
Red Medical Supplies: EcoGel 200 - RED Medical Supplies Blue Ultrasound Gel, Model No. 250UG-BMU
- Recall number
- Z-0088-2022
- Recalling firm
- Red Medical Supplies
- Product
- EcoGel 200 - RED Medical Supplies Blue Ultrasound Gel, Model No. 250UG-BMU
- Status
- Open, Classified
- Initiated
- 2021-08-11
- 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
- According to the firm, Amazon.com has issued recall notification to all customers via email. Customers were instructed to return the product as soon as possible. An automatic refund has been issued by Amazon.com as soon as the product was recalled. Amazon.com is in charge of the disposal.
- Quantity
- 3000
- Distribution
- Firm sold product through Amazon.com. Domestic distribution nationwide.
- Lot, serial or model codes
- All product manufactured by Eco-Med between 2020.09.23 - 2021.08.08
- 510(k) numbers
- ["K955246"]
- PMA numbers
- not on file
- Product code
- ITX
- Firm FEI
- 3012307634
- Firm city
- Vancouver
- Firm state
- not on file
- Firm country
- Canada
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