Ultra-Myossage recall: Contamination
Ultra-Myossage Lotion 1-gallon bottle, REF: 4262; Myossage Lotion 1-gallon bottle, REF: 4210, located in the following DJO, LLC / DJO FRANCE kits:
Why was Ultra-Myossage recalled?
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.
What should I do if I have this product?
The recall is ongoing. Follow the firm and FDA instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
All Lots manufactured by Eco-Med Pharmaceutical, Inc
- 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:
- Recalling firm
- DJO, LLC
- Quantity
- 8,702
- 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.
- Recall date
- October 13, 2021
- Classification
- Class I
- Status
- Ongoing
- Agency
- FDA (device)