Restoration Robotics Recalls Epsilon Skin Tensioner Due to Pin Discoloration
Restoration Robotics is recalling Epsilon Skin Tensioner devices because stainless steel pins may have discoloration from insufficient cleaning during passivation.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
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, and the hazard is limited to surface residue, fitting the Moderate criteria for low-risk contamination or labeling issues.
Plain-English summary
Restoration Robotics is recalling the Epsilon Skin Tensioner:Rx, a sterile medical device used to apply tension to the scalp during hair restoration procedures. The recall is due to reports of discoloration on the device's pins, which was identified as a compound of iron and chlorine resulting from insufficient cleaning during the passivation process.
The affected product is Model number FP-45384. The recall covers 515 units distributed in the United States and 315 units distributed internationally in Korea, Japan, Singapore, Thailand, the United Kingdom, Canada, and Taiwan.
The FDA has classified this as a Class II recall. Patients and healthcare providers should contact Restoration Robotics for further instructions regarding the use or return of these devices.
The recalled product
- Product
- Epsilon Skin Tensioner:Rx, Sterile Sterilized using Gamma. Turns Red if sterilized using Gamma; Product Usage: Skin Tensioner is applied to patients scalp during follicular harvesting during hair restoration procedure. Product applies tension to scalp to facilitate…
- Manufacturer
- Restoration Robotics
- Hazard
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-45384
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 ARTAS Disposable Kits Due to Pin Discoloration
FDA (Devices) · 2013-11-27
- ModerateRestoration Robotics Recalls Sterile Disposable Kits 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
Same hazard · contamination
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