FDA Device recall Z-0088-2022
EcoGel 200 - RED Medical Supplies Blue Ultrasound Gel, Model No. 250UG-BMU
- FDA Device
- Class I
- ongoing
- Published 2021-10-20
On 2021-10-20 the FDA classified a Class I recall of EcoGel 200 - RED Medical Supplies Blue Ultrasound Gel, Model No. 250UG-BMU by Red Medical Supplies, citing 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….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0088-2022 |
| Classification | Class I |
| Status | ongoing |
| Initiated | 2021-08-11 |
| Published | 2021-10-20 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Red Medical Supplies |
| Distribution | US |
Product
EcoGel 200 - RED Medical Supplies Blue Ultrasound Gel, Model No. 250UG-BMU
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.
Identifiers
| code_info | All product manufactured by Eco-Med between 2020.09.23 - 2021.08.08 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0088-2022%22
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