# FDA recall Z-0010-2022

> **DJO, LLC** · Class I · device recall initiated 2021-09-07.

## Product

Ultra-Myossage Lotion 1-gallon bottle, REF:  4262; Myossage Lotion 1-gallon bottle, REF: 4210, located in the following DJO, LLC / DJO FRANCE kits:

## 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 - U.S. Nationwide distribution including in the states of ND, NJ, CO, HI, CA, MA, FL, GA, IN, WA, NY, TX, IA, TN, NV, LA, CT, VA, NC, WI, MS, OR, MI, AL, MN, VT, IL, OH, AR, NM, DE, PA, SC, AZ, MD, RI, KY, UT, MO, OK, MT, ID, NE, WY, ME, WV, SD, KS, PR, NH, DC, AK, VI and the countries of France, China, Mexico, Ontario, Australia.

## Key facts

- **Recall number:** Z-0010-2022
- **Recalling firm:** DJO, LLC
- **Classification:** Class I
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2021-09-07
- **Report date:** 2021-10-13

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

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0010-2022

## Citation

> AI Analytics. FDA recall Z-0010-2022. Retrieved 2026-05-26 from https://api.ai-analytics.org/recall/Z-0010-2022. Source: US FDA. Licensed CC0.

---

*[Dataset catalog](/datasets/) · [FDA recalls dataset](/datasets/fda-recalls) · CC0 1.0*