# FDA recall Z-0194-2022

> **Lumenis, Inc.** · Class I · device recall initiated 2021-10-14.

## Product

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

## 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.

## 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, 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.

## Key facts

- **Recall number:** Z-0194-2022
- **Recalling firm:** Lumenis, Inc.
- **Classification:** Class I
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2021-10-14
- **Report date:** 2021-11-10
- **Termination date:** 2024-08-12

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Salt Lake City, UT, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0194-2022

## Citation

> AI Analytics. FDA recall Z-0194-2022. Retrieved 2026-06-09 from https://api.ai-analytics.org/recall/Z-0194-2022. Source: US FDA. Licensed CC0.

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