Sterile Disposable Kit — Class II medical device recall Z-0355-2014
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-0355-2014 |
|---|---|
| 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-45547 |
Product
Sterile Disposable Kit ( Contains Skin Tensioner ASY-25067; Three Mark Needle Assembly ASY-25094; Nose Cone Assembly ASY-25098; Dissection 4 mm PRT-25117, follicle Trap PRT 23999): 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
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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.