Restoration Robotics Recalls Sterile Disposable Kits Due to Pin Discoloration
Restoration Robotics is recalling sterile disposable kits used in hair restoration because skin tensioner pins have discoloration from insufficient cleaning.
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, and the hazard involves a manufacturing defect (residue) without reported injuries or illnesses, fitting the criteria for a moderate severity score.
Plain-English summary
Restoration Robotics is recalling the Sterile Disposable Kit, model number FP-45547. The kit contains a Skin Tensioner, Three Mark Needle Assembly, Nose Cone Assembly, Dissection 4 mm, and follicle Trap. The product is used during hair restoration procedures to apply tension to the scalp.
The recall was initiated due to reports of discoloration, or residue, on the pins of the skin tensioner. The residue was identified as a compound of iron and chlorine resulting from insufficient cleaning of the stainless steel pins during the passivation process.
A total of 515 units were distributed in the United States and 315 units were distributed internationally to Korea, Japan, Singapore, Thailand, the United Kingdom, Canada, and Taiwan. Customers who have received these kits should contact Restoration Robotics for further instructions.
The recalled product
- 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…
- 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-45547
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 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
Same hazard · contamination
See all →- SevereFDA Recalls Tirzepatide/Cyanocobalamin Injectable Due to Sterility Concerns
FDA (Drugs) · 2026-10-14
- ModerateAvid Medical Recalls Robotic Prostatectomy Packs for Lubricant Contamination
FDA (Devices) · 2026-10-14
- ModerateAVID Medical Recalls 23 ABD Hysterectomy Kits Due to Lubricant Contamination
FDA (Devices) · 2026-10-14
- SevereFDA Recalls Semaglutide/Cyanocobalamin Injectable Due to Sterility Concerns
FDA (Drugs) · 2026-10-14
- ModerateAVID Medical Recalls GYN Laparoscopy Kits for Potential Lubricant Contamination
FDA (Devices) · 2026-10-14
Similar recalls
- HighPro-Med Instruments Recalls DORO Sterile Disposable Skull Pins Due to Breakage
FDA (Devices) · 2017-12-13
- HighAesculap Disposable Trocars Recalled Due to Sterile Packaging Damage Risk
FDA (Devices) · 2024-03-13
- HighTeleflex Visistat Skin Staplers Recalled for Sterility Deficiency
FDA (Devices) · 2016-12-21
- ModerateEcolab Recalls Disposable Accessory Kits for Da Vinci Robotic System
FDA (Devices) · 2018-10-31
- HighMicroline ReNew Reusable Grasper and Dissector Tips Recalled for Insulation Failure
FDA (Devices) · 2018-02-14
- HighAesculap Disposable Trocars with Dilating Pins Recalled for Packaging Damage
FDA (Devices) · 2024-03-13