AQUABEAM Handpiece — Class II medical device recall Z-2330-2021
Ongoing recall by PROCEPT BIOROBOTICS CORPORATION, reported 2021-09-01, distributed nationwide. Scope tube tip may detach from the telescoping tube, which is attached to a single-use handpiece, a component
| Recall number | Z-2330-2021 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | PROCEPT BIOROBOTICS CORPORATION, Redwood City, CA, United States |
| Recall initiated | 2021-07-09 |
| Classified | 2021-08-20 |
| Reported by FDA | 2021-09-01 |
| Distributed | Nationwide (US) |
| Countries outside the US | AT, CH, DE, ES, FR, GB, IT |
| Quantity | 608 |
| Reason classes | device malfunction |
| Lot numbers | 21C00226, 21C00290, 21C00304, 21C00359, 21C00373, 21C00464, 21C00465, 21C00527 |
| Model numbers | HP2000 |
Product
AQUABEAM Handpiece, REF: HP2000, a sterile single-use component of the AQUABEAM Robotic System.
Reason for recall
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2330-2021. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.