# FDA recall Z-2583-2021

> **North Coast Medical Inc** · Class I · device recall initiated 2021-08-27.

## 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 for recall

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

## Distribution

Worldwide distribution.  US nationwide, Canada, Israel, South Africa, Australia, South Korea, France, Singapore, Grand Cayman, and Switzerland

## Key facts

- **Recall number:** Z-2583-2021
- **Recalling firm:** North Coast Medical Inc
- **Classification:** Class I
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2021-08-27
- **Report date:** 2021-10-06

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Morgan Hill, CA, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2583-2021

## Citation

> AI Analytics. FDA recall Z-2583-2021. Retrieved 2026-07-03 from https://api.ai-analytics.org/recall/Z-2583-2021. Source: US FDA. Licensed CC0.

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