Recall Z-0010-2022— DJO, LLC

Name: FDA recall Z-0010-2022
Creator: U.S. Food and Drug Administration
Published: 2021-09-07

Class I · Ongoing

Class I FDA medical device recall by DJO, LLC, initiated 2021-09-07. It names one FDA 510(k) clearance: K962840. 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: 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..

Recalling firm: DJO, LLC
Classification: Class I
Status: Ongoing
Initiated: 2021-09-07
Firm location: Carlsbad, CA, United States

510(k) clearances named in this recall

1 on FDA's record

K962840 — ECOLOTION TRANSMISSION AND MASSAGE LOTIONEco-Med Pharmaceuticals, Inc.·cleared 1996-12-23

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.