Facility

Procept Biorobotics c/o HealthLink Europe B.V.

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

Key facts

2recalls · worst Class II

—inspections in our data

—warning letters in our data

Recalls are listed for the parent company: openFDA recall records do not name a facility. How we attribute records

FDA Establishment Identifier (FEI)	3043534483
Establishment type	Export Device to the United States But Perform No Other Operation on Device
Location	Mechie Trommelenweg 8 Waalwijk Noord-Brabant, NL 5145 ND
Registration status	Active · expires 2026
Parent company	PROCEPT BioRobotics Corporation (owner-operator 10055490)
Brand names	Apogee 2300 with transducers ECBP-1

Activity by year

Recalls (2)

Devices registered here (3)

System, Imaging, Pulsed Doppler, Ultrasonic
Product code IYN (opens in a new tab) · Class II · Radiology · 21 CFR 892.1550
System, Imaging, Pulsed Echo, Ultrasonic
Product code IYO (opens in a new tab) · Class II · Radiology · 21 CFR 892.1560
Transducer, Ultrasonic, Diagnostic
Product code ITX (opens in a new tab) · Class II · Radiology · 21 CFR 892.1570

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…

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 c/o HealthLink Europe B.V. (FEI 3043534483) — FDA facility record.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/facility/3043534483-procept-biorobotics-c-o-healthlink-europ/

Not open yet

Alerts for Procept Biorobotics c/o HealthLink Europe B.V.

Watchlist alerts will email you when FDA publishes a new recall, inspection classification, or warning letter for a facility you follow. They aren't open to the public yet — leave your email and we'll tell you when they are.

Planned

Want a one-page facility brief?

A single-page summary of this facility's registration and recall history for diligence. Not selling it yet — register interest and we'll follow up.