Restoration Robotics Recalls ARTAS Hair Restoration Kits Due to Pin Residue
Restoration Robotics is recalling ARTAS hair restoration kits because skin tensioner pins contain iron and chlorine residue from insufficient cleaning.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, but the source text does not report any illnesses, injuries, or hospitalizations. The hazard involves chemical residue on a device component, which fits the criteria for a moderate severity recall without reported harm.
Plain-English summary
Restoration Robotics is recalling ARTAS Disposable and Reuseable Kits, including the Skin Tensioner, Inner Needle with Vacuum Tube, dissection Punch, Saline Nose Cone, Follicle Trap, and other components. The recall affects 515 units in the US and 315 units internationally, distributed in the US, Korea, Japan, Singapore, Thailand, United Kingdom, Canada, and Taiwan.
The recall was initiated after reports of discoloration on the pins of the skin tensioner. The residue was identified as a compound of iron and chlorine, resulting from insufficient cleaning of the stainless steel pins during the passivation process. The Skin Tensioner is applied to a patient's scalp during follicular harvesting to facilitate follicular extractions.
Healthcare providers and patients should stop using the affected ARTAS kits. The source text does not specify further consumer instructions or report any illnesses or injuries associated with the residue.
The recalled product
- Product
- 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):
- Manufacturer
- Restoration Robotics
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- Model number FP-45399
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 4 recalled by Restoration Robotics under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 4 products in this recall →Related recalls
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- ModerateRestoration Robotics Recalls Epsilon Skin Tensioner Due to Pin Discoloration
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