FDA Device recall Z-2583-2021
EcoLotion Transmission Lotion, used in ultrasound procedures
- FDA Device
- Class I
- ongoing
- Published 2021-10-06
On 2021-10-06 the FDA classified a Class I recall of EcoLotion Transmission Lotion, used in ultrasound procedures by North Coast Medical, 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 t….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2583-2021 |
| Classification | Class I |
| Status | ongoing |
| Initiated | 2021-08-27 |
| Published | 2021-10-06 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | North Coast Medical |
| Distribution | US |
Product
EcoLotion Transmission Lotion, used in ultrasound procedures. Item/Description: NC70481/Eco Lotion 5 liters, NC70482/Eco Lotion with Aloe 5 liters, NC70482C/Eco Lotion with Aloe 5 liters (4); Myossage Lotion, 1 Gallon, Item: NC31208
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 lots within the expiration date. |
|---|
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-2583-2021%22
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