Use cautionMedical device recall · FDA · Published July 9, 2021
Procept AQUABEAM HP2000 Handpiece Recall: Tip Detachment Risk
Procept recalls AQUABEAM HP2000 handpieces due to risk of tip detachment causing procedural delays. Affected units have specific lot numbers. Contact for replacement.
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 be seen cystoscopically and tip separation from the handpiece may necessitate tip removal from the bladder or prostate.
Take action
Contact the company
📍Recalling firmPROCEPT BIOROBOTICS CORPORATION900 Island Dr Ste 101 · Redwood City, CA 94065-5176
“Procept AQUABEAM HP2000 Handpiece Recall: Tip Detachment Risk.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/62228-procept-aquabeam-hp2000-handpiece-recall-tip-detachment-risk. Based on FDA recall #Z-2330-2021 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2330-2021%22&limit=1).
The FDA announced on July 9, 2021, that Procept Biometrics recalled the AQUABEAM Handpiece (REF: HP2000) due to a potential tip detachment hazard. The agency issued recall number Z-2330-2021 for the sterile single-use component of the AQUABEAM Robotic System.
How to tell if you have it
Brand: Procept Biometrics
Product: AQUABEAM Handpiece, REF: HP2000
Lot codes: 21C00226, 21C00290, 21C00304, 21C00359, 21C00373, 21C00464, 21C00465, 21C00527
Units affected: 608
The hazard
According to the FDA, the scope tube tip may detach from the telescoping tube attached to the handpiece. This detachment or separation can lead to procedural delays for handpiece exchange and may necessitate tip removal from the bladder or prostate.
Context
GovInfoNow's records show Procept Biometrics has one other recall on record since March 6, 2019. Other recent recalls of similar products include Merit Medical Custom Procedure Kit Recall (Dec. 4, 2025), Boston Scientific ENROUTE Transcarotid Neuroprotection System Recall (July 9, 2026), and Medtronic Harmony Catheter System Recall (May 22, 2026).
How to tell if you have this one
Check for lot numbers 21C00226, 21C00290, 21C00304, 21C00359, 21C00373, 21C00464, 21C00465, or 21C00527 on the handpiece packaging. The AQUABEAM HP2000 is a sterile single-use component for robotic surgery systems.
Brand
Procept Biometrics
Category
Medical device
Based on the official FDA remedy
What to do — step by step
Check Lot Numbers
Verify if your handpiece has any of the listed lot numbers: 21C00226, 21C00290, 21C00304, 21C00359, 21C00373, 21C00464, 21C00465, or 21C00527.
Where it went and when
Where it was distributed
Distributed nationwide and abroad; the notice names 17 states.
Named in the notice
Covered by “nationwide”
Not listed
FDA distribution: “Worldwide distribution - US Nationwide distribution in the states of FL, IL, TX, WI, AZ, AR, MI, WV, SD, PA, CA, DC, NJ, NY, GA, IN, VA, TN and the countries of Austria, Switzerland, Germany, Spain, France, UK, Italy.” States read from FDA’s own wording; “not listed” means the notice does not name it.
Named in the notice: Arizona, Arkansas, California, District of Columbia, Florida, Georgia, Illinois, Indiana, Michigan, New Jersey, New York, Pennsylvania, South Dakota, Tennessee, Texas, Virginia, West Virginia, Wisconsin.
Recall timeline
FDA published this recall 54 days after the firm started it.
1Firm started the recall
2FDA classified it Class II
3Published in FDA’s Enforcement Report
Dates from the agency record only; steps without a date are left out.
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
Official source: FDA Recall #Z-2330-2021 (July 9, 2021) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-2330-2021 to see it in context.
Plain-language summary written by qwen3:4b on August 19, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.