CLASS II Device recall · Reported 27 Nov 2013 · FDA Enforcement Report
Epsilon Skin Tensioner:Rx, Sterile Sterilized using Gamma recalled
Restoration Robotics is recalling Epsilon Skin Tensioner:Rx, Sterile Sterilized using Gamma, distributed nationwide in the US. The recall was initiated on 13 Oct 2013 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-0353-2014
- FDA event ID
- 66558
- Recalling firm
- Restoration Robotics, San Jose, CA
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 13 Oct 2013
- FDA classified
- 18 Nov 2013
- Reported
- 27 Nov 2013
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Foreign Material
- Device type
- Other Medical Devices
Timeline
| 13 Oct 2013 | Recall initiated by company | |
| 18 Nov 2013 | Classified by FDA | +36 days |
| 27 Nov 2013 | Published in enforcement report | +9 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
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.
Foreign material recalls cover pieces of metal, plastic, glass, wood or other objects that got into the product during processing and could cause injury if eaten.
Product as listed by the FDA
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 follicular extractions.
Where it was distributed
Worldwide Distribution - USA Nationwide in the countries of: Korea, Japan, Singapore, Thailand, United Kingdom, Canada, and Taiwan.
Questions about this recall
Why was it 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.
Which lots are affected?
Model number FP-45384
Where was it sold?
Worldwide Distribution - USA Nationwide in the countries of: Korea, Japan, Singapore, Thailand, United Kingdom, Canada, and Taiwan.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
3 other products · FDA event 66558| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS II | Artas Disposable Kit ( Contains Skin Tensioner FP recalled | Restoration Robotics | Foreign Material | Nationwide | |
| CLASS II | Artas Disposable and Reuseable Kit recalled by Restoration Robotics | Restoration Robotics | Foreign Material | Nationwide | |
| CLASS II | Sterile Disposable Kit ( Contains Skin Tensioner ASY recalled | Restoration Robotics | Foreign Material | Nationwide |
More recalls from Restoration Robotics
All 4| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Sterile Disposable Kit ( Contains Skin Tensioner ASY recalled | Restoration Robotics | Foreign Material | Nationwide |
| Device | CLASS II | Artas Disposable and Reuseable Kit recalled by Restoration Robotics | Restoration Robotics | Foreign Material | Nationwide |
| Device | CLASS II | Artas Disposable Kit ( Contains Skin Tensioner FP recalled | Restoration Robotics | Foreign Material | Nationwide |
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| Device | CLASS II | Halyard IV Start Kit Non-Sterile recalled by Avid Medical | Avid Medical | Sterility | Nationwide |
| Device | CLASS I | Kit: Single Shot Epidural 20/Cs recalled by Medical Action Industries | Medical Action Industries Inc. 306 | Sterility | 6 states |
| Device | CLASS II | AMS Convenience Kit: Dsaek Pack - RX recalled | Windstone Medical Packaging | Device Malfunction | Nationwide |