Lumenis, Inc.: Medical Device Recall in 2021 - (Recall #: Z-0194-2022)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2021.

Data Source: FDA.

Product Description:

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

Product Classification:

Class I

Date Initiated: October 14, 2021

Date Posted: November 10, 2021

Recall Number: Z-0194-2022

Event ID: 88863

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.

Status: Terminated

Product Quantity: 11,064

Code Information:

Distributed within the last three years

Distribution Pattern:

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, SD, NV, AL, DC, OR, VT, ND, DE, HI and the countries of AT, AU, DE, GB, HK, IT, KR, CN, FR, IE, IN, LK, JP, MO, NZ, PR, TT, TW, MN, TH, CH.

Voluntary or Mandated:

Voluntary: Firm initiated