Salt Lake City, UT, United States
LUMENIS, LTD. recalls
3 recalls recorded since 2018, most recently on 22 July 2025. 2 are listed as ongoing. Status and classification are as published by the FDA.
Recalls3
Ongoing (FDA)2
Terminated or completed1
Class I (FDA)1
Ongoing Class II Medical devices
- Recall started
- 22 July 2025
- Reason
- The potential for unsterilized product within finished product labeled as sterile.
- Distribution
- Domestic: PA, WI; International: Germany, India;
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-2344-2025
- OtoLase Starter Kit; UPN: AC-2003748. Indicated for a variety of surgical uses including ablation, coagulation, incision, excision, and vaporization of soft tissue.
Ongoing Class II Medical devices
- Recall started
- 23 January 2025
- Reason
- The initial current in certain chargers may lead to overheating and damage to the power resistors on the Alternating Current (AC) controller during the power-on sequence of the laser system, resulting in the laser system to not power on.
- Distribution
- Distribution was made to PA. There was no government/military distribution. Foreign distribution was made to Mexico and Spain.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1290-2025
- (1) Lumenis Pulse 120H 30 amp, REF GA 2009996, Laser System; (2) Lumenis Pulse 120H, Moses 2.0 (DOM), REF GA0006802, Laser System; and (3) Lumenis Pulse 120H, REF GA-0008700, Laser System.
Terminated Class I Medical devices
- Recall started
- 14 October 2021
- Terminated
- 12 August 2024
- Reason
- 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,
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0194-2022
- 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
A terminated FDA recall means the FDA has determined that all reasonable efforts to remove or correct the product have been made. What statuses mean.