RegWardenFDA facility compliance records
Facility

PROCEPT BioRobotics Corporation

2 recall(s) on record — most severe on record: Class II.

Activity by year

FDA actions on record by year2019: 1 recalls; 2021: 1 recalls201720181201920201202120222023202420252026
  • Recalls (2)

Devices registered here (1)

  • Fluid Jet Removal System
    Product code PZP (opens in a new tab) · Class II · General, Plastic Surgery · 21 CFR 876.4350

Recalls & enforcement

  • Class IIOngoing2021-07-09
    Scope tube tip may detach from the telescoping tube, which is attached to a single-use handpiece, a component of an aquablation robotic system. Both tip detachment and entire tip separation form the handpiece may lead to procedural delay for handpiece exchange. Tip detachment can…
  • Class IITerminated2019-03-06
    Certain lots may develop an internal leak due to a micro-crack in a specific weld joint within the device. When the Robot detects this failure, it immediately renders the device inoperable and notifies the user via an error message, which may cause delay and/or inability to compl…

Related

Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this facility record at FDA → (opens in a new tab)

Cite this record

RegWarden. “PROCEPT BioRobotics Corporation (FEI 3027788423) — FDA facility record.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/facility/3027788423-procept-biorobotics-corporation/

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