Restoration Robotics Recalls ARTAS Disposable Kits Due to Pin Discoloration
Restoration Robotics is recalling ARTAS Disposable Kits because skin tensioner pins have discoloration from insufficient cleaning during manufacturing.
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. The hazard involves manufacturing residue (iron and chlorine) on pins, which is a quality control issue without reported injuries or illnesses, fitting the criteria for moderate severity.
Plain-English summary
Restoration Robotics is recalling ARTAS Disposable Kits and ARTAS Disposable Kits, 18 Gauge Epsilon. The recall involves 515 units in the US and 315 units internationally. The products are prescription medical devices used during hair restoration procedures.
The recall was initiated due to reports of discoloration, or residue, on the pins of the skin tensioner component. 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 affected products were distributed worldwide, including in the United States, Korea, Japan, Singapore, Thailand, United Kingdom, Canada, and Taiwan. Healthcare providers and patients should stop using the affected kits and contact Restoration Robotics for instructions on return or replacement.
The recalled product
- Product
- ARTAS Disposable 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 and Non-sterile Disposable Clinical Kit FP -23267): and ARTAS Disposable Kits, 18 Gauge Epsilon
- 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-45616 and FP45173
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
Same manufacturer · Restoration Robotics
See all →- ModerateRestoration Robotics Recalls Sterile Disposable Kits Due to Pin Discoloration
FDA (Devices) · 2013-11-27
- ModerateRestoration Robotics Recalls Epsilon Skin Tensioner Due to Pin Discoloration
FDA (Devices) · 2013-11-27
- ModerateRestoration Robotics Recalls ARTAS Hair Restoration Kits Due to Pin Residue
FDA (Devices) · 2013-11-27
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