Serious health hazard — there is a reasonable probability that use of or exposure to this product will cause serious adverse health consequences or death.
IPL Coupling Gel Recalled by Lumenis, Inc. Due to Ultrasound gels and lotions manufactured by Eco-Med Pharmaceutical,...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Lumenis, Inc. directly.
Affected Products
IPL Coupling Gel, I L (AX1009013), 12 pack of 0.25 L (AX1009018), 6 pack of 1 L (AX1009019 or AX1009063); and IPL Coupling Gel or EcoGel 200, 0.25 L (AX1009012) manufactured by Eco-Med Pharmaceutical
Quantity: 11,064
Why Was This 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.
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About Lumenis, Inc.
Lumenis, Inc. has 3 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report