FDA-Device2021-10-13Class I
Ultra-Myossage Lotion 1-gallon bottle, REF: 4262; Myossage Lotion 1-gallon bottle, REF: 4210, located in the following DJO, LLC / DJO FRANCE kits:
Hazard
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.
Sold states
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.
Affected count
8,702
Manufactured in
5919 Sea Otter Pl Ste 200, Carlsbad, CA, United States
Products
Ultra-Myossage Lotion 1-gallon bottle, REF: 4262; Myossage Lotion 1-gallon bottle, REF: 4210, located in the following DJO, LLC / DJO FRANCE kits:
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0010-2022More DJO, LLC recalls
- FDA-Device2026-05-20DJO DONJOY IceMan CLASSIC3 cold therapy unit recalled for broken connector
- FDA-Device2026-05-20DJO DONJOY ICEMAN CLASSIC CUBE cold therapy unit recalled for broken connector
- FDA-Device2026-05-20DJO DONJOY ICEMAN CLASSIC3 cold therapy unit recalled for broken connector risk
- FDA-Device2026-05-20DJO IceMan CLASSIC3 cold therapy unit recalled for broken connector
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