The Recall Desk

Manufacturer

Restoration Robotics

4 recalls in our database name Restoration Robotics as the manufacturing or recalling firm.

What the numbers show

Total
4
Critical
0
Severe
0
Most recent
2013-11-27

Of the 4 recalls from Restoration Robotics we have scored against our rubric, 0 (0%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 0 (0%) are Severe.

About this listing

The manufacturer string comes from the agency’s own source notice — for FDA recalls, the “recalling firm” field; for NHTSA recalls, the vehicle manufacturer; for CPSC recalls, the firm-of-record on the joint press release. A single corporate family can appear under multiple manufacturer strings as agency notices aren’t standardized on a canonical name. If you don’t see recalls you expect, try a parent-company search or a broader full-text search.

Severity scores below are computed from the agency’s classification and the recall text, never from manufacturer behaviour or history. Many manufacturers issue routine corrective actions (software updates, labelling corrections) that are correctly scored low — having recalls on this list isn’t inherently a quality signal.

1–4 of 4

  • ModerateFDA (Devices)·Z-0354-2014·2013-11-27

    Restoration Robotics Recalls ARTAS Disposable Kits Due to Pin Discoloration

    Restoration Robotics is recalling ARTAS Disposable Kits because skin tensioner pins have discoloration from insufficient cleaning during manufacturing.

    Product
    ARTAS Disposable Kit ( Contains Skin Tensioner FP-45384; Inner Needle with Vacuum Tube FP-45385; Dissection Punch 4.0mm FP-23304; Saline Nose Cone FP-45387; Follicle Trap - FP-23306 and Non-sterile Disposable Clinical Kit FP -23267): and ARTAS Disposable Kits, 18 Gauge Epsilon
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0355-2014·2013-11-27

    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.

    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 dur
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0353-2014·2013-11-27

    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.

    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 follicul
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0356-2014·2013-11-27

    Restoration Robotics Recalls ARTAS Hair Restoration Kits Due to Pin Residue

    Restoration Robotics is recalling ARTAS hair restoration kits because skin tensioner pins contain iron and chlorine residue from insufficient cleaning.

    Product
    ARTAS Disposable and Reuseable Kit ( Contains Skin Tensioner FP-45384; Inner Needle with Vacuum Tube FP-45385; dissection Punch 4.0mm FP 23304; Saline Nose Cone FP-45387; Follicle Trap FP 23306; Non-Sterile Disposable kit FP 23267 and Molded Parts, Reusable Kit FP 45538 Rx):
    Category
    Medical Device
    Distribution
    Distributed nationwide