RobotRisk › Procept BioRobotics › 09 Jul 2021

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

S3 · 09 Jul 2021 · Procept BioRobotics

Record

Company	Procept BioRobotics
Industry	Medical robotics
Type(s)	recall
Date	09 Jul 2021 (day precision)
Time of day	not documented
Location	no physical site (recall / fleet-wide / aggregate record)
Severity	(recall, enforcement, or fleet-wide fault)
Scale	AQUABEAM Handpiece, REF: HP2000, a sterile single-use compon
Confidence	high
Verified flag	Yes - independently re-checked against the cited source

Summary

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

Primary source

openFDA enforcement

Publisher: openFDA enforcement · Retrieved: 2026-09-16

Supporting source rows (1)

Date	Supporting source row	Publisher	Link
09 Jul 2021	FDA Class II recall: AQUABEAM Handpiece, REF: HP2000, a sterile single-use component of the	openFDA enforcement	openFDA enforcement

Procept BioRobotics other incidents timeline

Medical robotics context

recall context

Procept BioRobotics industry position

Related incidents

Sev	Date	Company	Incident
S3	06 Mar 2019	Procept BioRobotics	FDA Class II recall: AquaBeam Handpiece, Sterile EO, Rx Only, REF: 310301, and 320301, a co
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Other Procept BioRobotics entries

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

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