Z-0010-2022Class I

Ultra-Myossage Lotion 1-gallon bottle, REF: 4262; Myossage Lotion 1-gallon bottle, REF: 4210, located in the...

Name: Z-0010-2022 Ultra-Myossage Lotion 1-gallon bottle, REF: 4262; Myossage Lotion 1-gallon bottle, REF: 4210, located in the...
Creator: Djo, Llc
Published: 2021-09-07
License: https://open.fda.gov/license/

DJO, LLC / initiated 2021-09-07 / Open, Classified / root cause: manufacturing process

FDA source

DJO, LLC began a recall of Ultra-Myossage Lotion 1-gallon bottle, REF: 4262; Myossage Lotion 1-gallon bottle, REF: 4210, located in the following DJO, LLC / DJO FRANCE kits on 2021-09-07. FDA classified it as Class I and gives the reason as "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...". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0010-2022
Classification: Class I
Status: Open, Classified
Initiated: 2021-09-07
Posted: 2021-10-05
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:
Product code: ITX Transducer, Ultrasonic, Diagnostic
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.
Root cause tag: manufacturing process
FDA 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 [email protected]. The following website is provided: djoglobal.com
Quantity in commerce: 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.
Product codes and lots: All Lots manufactured by Eco-Med Pharmaceutical, Inc

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0010-2022
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0009-2022	Class I	Ongoing	Voluntary: Firm initiated	2021-10-13	2021-10-05
Z-0010-2022	Class I	Ongoing	Voluntary: Firm initiated	2021-10-13	2021-10-05

Product code ITX

K962840Class IIEcolotion Transmission and Massage LotionEco-Med Pharmaceuticals, Inc. / cleared 1996-12-23

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)