FDA Medical Device Recalls (openFDA)
DJO, LLC: Ultra-Myossage Lotion 1-gallon bottle, REF: 4262; Myossage Lotion 1-gallon bottle, REF: 4210, located in the following DJO, LLC / DJO FRANCE kits:
- Recall number
- Z-0010-2022
- Recalling firm
- DJO, LLC
- 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:
- Status
- Open, Classified
- Initiated
- 2021-09-07
- Posted
- not on file
- Terminated
- not on file
- 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.
- Root cause
- Process control
- Action
- On 09/03/21, recall notices were mailed and emailed to customers. Customers were asked to take the following action: a) Immediately remove and destroy the gel products located in the DJO, LLC / DJO FRANCE kits that contain the affected product. Follow all local/state or country regulations for disposal b) Immediately stop use of ALL ultrasound gels and lotions labeled manufactured by Eco-Med Pharmaceutical (regardless of lot). c) In addition, if you have further distributed this product, please identify your customers, and notify them at once of this product recall by sharing this recall notification letter. d) DJO, LLC / DJO FRANCE has partnered with Stericycle/Sedgwick as our vigilance partner. Please complete the attached Return Response and return to DJOglobalrecall@sedgwick.com. The following website is provided: djoglobal.com
- 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.
- Lot, serial or model codes
- All Lots manufactured by Eco-Med Pharmaceutical, Inc
- 510(k) numbers
- ["K962840"]
- PMA numbers
- not on file
- Product code
- ITX
- Firm FEI
- 3017264244
- Firm city
- Carlsbad
- Firm state
- CA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28