Device recalls
Device recalls with the root cause, the firm, the products and the recall status. 59,344 records; openFDA updated it 2026-10-05. About this dataset
6 records match “laser hair removal”
- Labeling False and Misleading2
- Error in labeling1
- Nonconforming Material/Component1
- Package design/selection1
- Radiation Control for Health and Safety Act1
- Brand Name: LEASEIR Product Name: LEASEIR MHR XCELL Model/Catalog Number: MHR 110-b Software Version: 1.5.0.0 Product Description: The Leas…FDA page
LEASEIR TECHNOLOGIES SLU · The console label for affected devices is missing the "DANGER" symbol.
- Diode Laser Hair Removal model: WLA-01FDA page
WINGDERM ELECTRO-OPTICS LTD. · All model WLA-01 systems sold to US customers are found to have labeling non-compliances
- Multilite Dye Handpieces, an optional accessory of the RevLite SI Laser. The Revlite SI laser is intended for General Dermatology, Dermatol…FDA page
ConBio, a CynoSure Company · An inconsistency was identified related to electronic display identification of the optional Multilite Dye Handpieces of the RevLite SI Laser system that may c…
- Q-Plus T Powered Laser Surgical Instrument Nd:YAG 1064 nm and 532 nm: Treatment of vascular lesions and pigmented lesions; Hair and tattoo…FDA page
Quanta System, S.p.A. · Quanta System S.p.A, Italy, is notifying U.S. consignees that their website contained promotional materials for products distributed in the U.S. which did not…
- Ultrawave II EX 1320/ Ultrawave III EX 1320 Powered Laser Surgical Instrument. Nd:YAG 1064 nm: Coagulation and hemostasis of benign vascula…FDA page
Quanta System, S.p.A. · Quanta System S.p.A, Italy, is notifying U.S. consignees that their website contained promotional materials for products distributed in the U.S. which did not…
- Dornier Diode Laser Fibers:Used with Dornier Medilas D Family Lasers Part Number/Description: K1001291 600 micron single use fiber K2011824…FDA page
Dornier Medtech America, Inc. · Pin hole package failures compromising sterility of product
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Data from openFDA, FDA's public API. FDA says not to rely on it to make decisions about medical care and to treat every result as unvalidated; confirm against FDA's own record and the product labeling. Not medical or legal advice.