Lumenis recalls
3 official recalls and safety alerts involving Lumenis since 2021-11, from FDA · Device. Newest first. Check the official notice for exact models and batch codes.
This list only includes recalls Recall Atlas has collected since 2021-10. A product not listed here may still be affected; check with Lumenis or the relevant agency.
- 2025-08-27
USLUMENIS, LTD. recalls OtoLase Starter Kit; UPN: AC-2003748. Indicated for a variety of surgical uses including ablation, coagulation, incision, excision, and…
The potential for unsterilized product within finished product labeled as sterile.
- 2025-03-12
- US
LUMENIS, LTD. recalls (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)…
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…
FDA · DeviceLUMENIS, LTD.Distribution was made to PA. There was no government/military distribution.…Official notice → - 2021-11-10
- US
Lumenis, Inc. recalls 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…
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:…
FDA · DeviceLumenis, Inc.Worldwide distribution - US Nationwide distribution in the states of KS, PR,…Official notice →