Recall & Approval Tracker
A running timeline of FDA recalls and device clearances that touch medical aesthetics — what changed, when, and what it means for med spa owners.
3 recalls 25 clearances last 180 days
- FDA CLEARED Disposable Blood Lancet (Soft) — SteriLance Medical (Suzhou), Inc.
- FDA CLEARED Intense Pulsed Light Therapy Device — Sanhe LEFIS Electronics Co., Ltd.
- FDA CLEARED Barbed PDO Suture — Sutura Medical Technology, Inc.
- FDA CLEARED Dexter L6 System — Distalmotion SA
- FDA CLEARED TekBrace Solo Soft Tissue Reinforcement Device — Theramicro
- FDA CLEARED ERBECRYO 2 Cryosurgical Unit and Accessories — Erbe Elektromedizin GmbH
- FDA CLEARED LAP-iX2N — Sejong Medical Co., Ltd.
- FDA CLEARED Lipocosm Harmonic System — Lipocosm, LLC
- FDA CLEARED OsteoCool RF Ablation System; OsteoCool 2.0 RF Ablation System — Medtronic Sofamor Danek USA, Inc.
- FDA CLEARED GT Metabolic MagDI System (MAG-01, MAG-02, DS-01) — Gt Metabolic Solutions, Inc.
- FDA CLEARED Tuff Cuff Disposable Surgical Gowns AAMI L4 Sterile-Large (ML-L4-STL-DC-L) — New York Embroidery Studio (NYES)
- FDA CLEARED LumiGlam Laser System (SHE-LSP601-3) — Beijing Sano Laser S&T Development Co.,Ltd
- FDA CLEARED Tissue Approximation System — Tas Medical, Inc.
- FDA CLEARED CurrentBody Skin LED Multi Light Therapy Mask (MK-110D) — The Beauty Tech Group, Ltd.
- FDA CLEARED Hemospray Endoscopic Hemostat (HEMO-[X]) — Wilson-Cook Medical, Inc.
- FDA CLEARED MILAN System — Lumenis Be, Ltd.
- FDA CLEARED Veineo System (00MEDRF4000TCUS 05CR45iT 06Pedal1St) — F Care Systems USA, LLC
- FDA CLEARED VisionAir Enhanced Stock Stent — VisionAir Solutions
- FDA CLEARED ENTire IRE System — Entire Medical , Ltd.
- FDA CLEARED LASEmaR 1500 — Eufoton S.R.L.
- FDA CLEARED LUNE PureHygiene — Enamel Pure
- FDA CLEARED Trexon Monofilament Synthetic Absorbable Suture — Medtronic
- FDA CLEARED RENASYS EDGE (66803126) — Smith & Nephew Medical, Ltd.
- FDA CLEARED Momcozy Nasal Aspirator (BN007) — Shenzhen Root Innovation Technology Co., Ltd.
- FDA CLEARED VIVA combo RF System — Starmed Co., Ltd.
- RECALL PAYLESS COMPOUNDERS, LLC — Semaglutide-Glycine-Cyanocobalamin Injectable, 2.5 mg, 5 mg, 1 MG/ML, 0.5 mL via
- RECALL HTO Nevada Inc. dba Kirkman — MAXIMUM, ZONE 1, 4% Lidocaine Cream, 1/2 oz bottles, Distributed By: Dermal Sour
- RECALL Pro Numb Tattoo Numbing Spray LLC — Pro Numb Tattoo Numbing Spray, For Sensitive Skin, 4% Lidocaine, [1FL OZ/28.4 ML
We surface entries from FDA public databases (device & drug recalls, 510(k) clearances) filtered to the medical-aesthetics space, newest first. Each post links to the official FDA record. General business information, not medical, legal, or regulatory advice — confirm details at the source.
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