Epsilon Skin Tensioner:Rx — Class II medical device recall Z-0353-2014
Terminated recall by Restoration Robotics, reported 2013-11-27, distributed nationwide. Reports of discoloration (residue) on the pins of the skin tensioner have been received by several customers.
| Recall number | Z-0353-2014 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Restoration Robotics, San Jose, CA, United States |
| Recall initiated | 2013-10-13 |
| Classified | 2013-11-18 |
| Reported by FDA | 2013-11-27 |
| Terminated | 2013-12-10 |
| Distributed | Nationwide (US) |
| Countries outside the US | CA, GB, JP, KR, SG, TH, TW |
| Model numbers | FP-45384 |
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 follicular extractions.
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0353-2014. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.