Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
ARTAS Disposable and Reuseable Kit ( Contains Skin Tensioner FP-45384 Recalled by Restoration Robotics Due to Reports of discoloration (residue) on the pins of...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Restoration Robotics directly.
Affected Products
ARTAS Disposable and Reuseable Kit ( Contains Skin Tensioner FP-45384; Inner Needle with Vacuum Tube FP-45385; dissection Punch 4.0mm FP 23304; Saline Nose Cone FP-45387; Follicle Trap FP 23306; Non-Sterile Disposable kit FP 23267 and Molded Parts, Reusable Kit FP 45538 Rx): Product Usage: Skin Tensioner is applied to patients scalp during follicular harvesting during hair restoration procedure. Product applies tension to scalp to facilitate follicular extractions.
Quantity: 515 US, 315 International (all Packaging configurations.
Why Was This Recalled?
Reports of discoloration (residue) on the pins of the skin tensioner have been received by several customers. Discoloration due to insufficient cleaning of stainless steel pins during passivation process. The residue has been identified as a compound of iron and chlorine.
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About Restoration Robotics
Restoration Robotics has 4 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report