Class II — PROCEPT BIOROBOTICS CORPORATION
| Recalling firm | PROCEPT BioRobotics Corporation |
|---|---|
| Registered facility | View this company's 2 registered facilities → (openFDA recall records do not name a specific facility) |
| Classification | Class II |
| Status | Ongoing |
| Reason | 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. |
| Product | AQUABEAM Handpiece, REF: HP2000, a sterile single-use component of the AQUABEAM Robotic System. |
| Quantity | 608 |
| 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. |
| Initiated | 2021-07-09 |
| Classified | 2021-08-20 |
| Recall number | Z-2330-2021 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — PROCEPT BIOROBOTICS CORPORATION (Z-2330-2021).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/88337/
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