Lower riskMedical device recall · FDA · Published October 14, 2021
Lumenis IPL Coupling Gel Recall: Bacterial Contamination Risk
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.
📍Recalling firmLumenis, Inc.1870 S Milestone Dr · Salt Lake City, UT 84104-6541
✎ GovInfoNow plain-language explainer
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. Read more at govinfonow.com/recall/61682-lumenis-ipl-coupling-gel-recall-bacterial-contamination-risk.
“Lumenis IPL Coupling Gel Recall: Bacterial Contamination Risk.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/61682-lumenis-ipl-coupling-gel-recall-bacterial-contamination-risk. Based on FDA recall #Z-0194-2022 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0194-2022%22&limit=1).
The FDA announced on Oct. 14, 2021, that Lumenis, Inc. is recalling ultrasound gels and lotions manufactured by Eco-Med Pharmaceutical, Inc. The agency stated the products may contain bacterial contamination.
How to tell if you have it
Lumenis IPL Coupling Gel, I L (AX1009013)
Lumenis IPL Coupling Gel, 12 pack of 0.25 L (AX1009018)
Lumenis IPL Coupling Gel, 6 pack of 1 L (AX1009019 or AX1009063)
Lumenis IPL Coupling Gel or EcoGel 200, 0.25 L (AX1009012)
The hazard
According to the FDA, ultrasound gels and lotions manufactured by Eco-Med Pharmaceutical, Inc. may contain bacterial contamination. The agency published a Letter to Health Care Providers on Aug. 18, 2021, to address this issue.
Context
GovInfoNow's records show other recent recalls of similar products include Medline Convenience Kits Recall: Risk of Microbial Contamination from Packaging Wrinkles (2026-06-12) and Medline Convenience Kits Recall: Fungal Contamination Risk (2026-08-11). Other recent recalls of similar products include Medline Medical Kits Recall: Non-sterile Alcohol Prep Pads Risk (2026-03-16).
How to tell if you have this one
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.
Brand
Lumenis
Category
Medical device
Based on the official FDA remedy
What to do — step by step
Check Product Labels
Look for model numbers AX1009013, AX1009018, AX1009019, or AX1009063 on the packaging.
Where it went and when
Where it was distributed
Distributed nationwide and abroad; the notice names 49 states.
Named in the notice
Covered by “nationwide”
Not listed
FDA distribution: “Worldwide distribution - US Nationwide distribution in the states of KS, PR, MO, MA, NJ, NH, CA, CO, GA, NC, NY, FL, AZ, ID, IN, TX, CT, WV, UT, LA, OH, KY, SC, WA, MN, AK, IA, MD, NM, TN, RI, PA, AR, VA, IL, MI, NE, WY, ME, WI, OK, MS,…” States read from FDA’s own wording; “not listed” means the notice does not name it.
Named in the notice: Alabama, Alaska, Arizona, Arkansas, California, Colorado, Connecticut, Delaware, District of Columbia, Florida, Georgia, Hawaii, Idaho, Illinois, Indiana, Iowa, Kansas, Kentucky, Louisiana, Maine, Maryland, Massachusetts, Michigan, Minnesota, Mississippi, Missouri, Nebraska, Nevada, New Hampshire, New Jersey, New Mexico, New York, North Carolina, North Dakota, Ohio, Oklahoma, Oregon, Pennsylvania, Puerto Rico, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Vermont, Virginia, Washington, West Virginia, Wisconsin, Wyoming.
Recall timeline
FDA terminated this recall 2.8 years after the firm started it.
1Firm started the recall
2FDA classified it Class I
3Published in FDA’s Enforcement Report
4FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
Take action
Contact Lumenis
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 IPL Coupling Gel Recall: Bacterial Contamination Risk
Hello,
I own a Lumenis IPL Coupling Gel Recall: Bacterial Contamination Risk 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.
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.
Official source: FDA Recall #Z-0194-2022 (October 14, 2021) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0194-2022 to see it in context.
Plain-language summary written by qwen3:4b on August 19, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.