RobotRisk / Procept BioRobotics / 2021-07-09

FDA Class II recall: AQUABEAM Handpiece, REF: HP2000, a sterile single-use component of the

S3 · 07/09
2021 · Procept BioRobotics

Record

Company	Procept BioRobotics
Category	medical robotics
Type	recall
Date	07/09 2021
Time of day	not documented
Location	no physical site (recall / fleet-wide / aggregate record)
Severity	S3 (recall, enforcement, or fleet-wide fault)
Scale	AQUABEAM Handpiece, REF: HP2000, a sterile single-use compon
Confidence	high
Verification	Yes - adversarially checked against the cited source
Source	openFDA enforcement

What happened

FDA enforcement record (Class II, recall Z-2330-2021): 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

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Procept BioRobotics vs medical robotics alternatives

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Comparable recall events in medical robotics

Sev	Date	Company	Event
S2	2026-06-09	CMR Surgical	Class II recall of Versius surgeon console over disabled Secure Boot cybersecurity control
S4	2026-03-25	Omnicell	FDA Class I recall: Rolls of label stock used with the Omnicell i.v.Station.
S5	2026-03-11	Intuitive Surgical	Class I recall of da Vinci SureForm stapler reloads after patient death
S3	2026-01-21	Auris Health (J&J MedTech)	FDA Class II recall: MONARCH Platform, Bronchoscopy, Catalog Numbers: MON-000005-01 , MON-0
S3	2025-09-12	Noah Medical	FDA Class II recall: Brand Name: Galaxy System
S3	2025-05-23	Quantum Surgical	FDA Class II recall: EPIONE Model 30-0001
S3	2025-04-23	Virtual Incision	FDA Class II recall: MIRA SURGICAL SYSTEM, Table mounted miniaturized electromechanical sur
S3	2025-02-26	Intuitive Surgical	Class II recall of da Vinci 5 foot pedal over spring failure

Other Procept BioRobotics entries

03/06
2019 - FDA Class II recall: AquaBeam Handpiece, Sterile EO, Rx Only, REF: 310301, and 320301, a co

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