Lumenis recalls IPL coupling gels and devices due to potential bacterial contamination. FDA advises stopping use of Eco-Med ultrasound gels and lotions. Affected products include specific model numbers and packaging sizes.
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.
Lumenis is recalling certain IPL coupling gels and devices because they may contain bacterial contamination. This poses a health risk as bacteria could cause infections if the products are used on skin. The recall follows a FDA warning about the issue.
The recalled gels and devices may contain bacteria that can cause skin infections if used on the skin. This is a health risk because bacteria can enter the body through small cuts or breaks in the skin during treatment.
People who own or use the recalled IPL coupling gels or devices are affected. Those with sensitive skin or who use the products for medical treatments may be at higher risk of infection.
Check for product labels with model numbers AX1009013, AX1009018, AX1009019, or AX1009063. The products were distributed within the last three years and include specific packaging sizes.
Look for model numbers AX1009013, AX1009018, AX1009019, or AX1009063 on the packaging.
The FDA has warned that Eco-Med ultrasound gels and lotions may contain bacterial contamination, which could cause skin infections if used on the skin.
The recall record does not specify a remedy, so you should check with Lumenis for further instructions.
Yes, the affected models include 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).
We’ve drafted a message you can send Lumenis to request your refund or repair — edit it as you like.
Subject: Recall Z-0194-2022 — Lumenis Lumenis Hello, I own a Lumenis that is covered by recall Z-0194-2022 from Lumenis. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
