Severity
Moderate
ModerateClass IITerminated
FDA Devices recall · Reported April 17, 2019
AquaBeam Handpiece, Sterile EO, Rx Only, REF: 310301, and 320301, a component of AquaBeam Robotic System. 320301 distributed outside the U.S. Device Description The AQUABEAM Robotic System is intended for use in patients suffering from lower urinary tract symptoms resulting from benign prostatic hyperplasia (BPH).
Certain lots may develop an internal leak due to a micro-crack in a specific weld joint within the device. When the Robot detects this failure, it immediately renders the device i…
Procept Biorobotics Corporation recalled AquaBeam Handpiece, Sterile EO, Rx Only, REF: 310301, and 320301, a component of AquaBeam… - a moderate-severity action.
AquaBeam Handpiece, Sterile EO, Rx Only, REF: 310301, and 320301, a component of AquaBeam… was recalled by Procept Biorobotics Corporation in April 17, 2019. Reason: Certain lots may develop an internal leak due to a micro-crack in a specific weld joint within the device. Wh…. Check the official notice for the remedy. Verify recall #Z-1110-2019 with the FDA Devices before acting.
The recall
Procept Biorobotics Corporation issued this moderate-severity FDA Devices recall-Certain lots may develop an internal leak due to a micro-crack in a specific weld joint within the device. Wh….
- Moderate
- severity level
- 214 units
- affected scope
- Class II
- classification
- April 17, 2019
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-1110-2019 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-1110-2019) was formally reported on April 17, 2019, with the manufacturer initiating the action on March 6, 2019. It is classified under Moderate severity (Class II), with a current status of Terminated. Procept Biorobotics Corporation is listed as the recalling firm, operating out of Redwood City, CA. Federal records list the affected scope as 214.
The documented reason for this recall is: Certain lots may develop an internal leak due to a micro-crack in a specific weld joint within the device. When the Robot detects this failure, it immediately renders the device inoperable and notifies the user via an e… Distribution data in the federal record shows the product reached: Worldwide Distribution: US (nationwide) state to: TX, FL, IN, CA, IL, VA, MI, PA.; and (OUS) countries of: Italy, Germany, France, Poland, United Kingdom, Spain, Canada and Australia.. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.
Within the same product category the archive holds 6 closely related recalls, 6 from FDA Devices - clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.
Medical Devices recalls over time
Where this recall sits in its category - 40,861 medical devices recalls on record
Of 88,001 recalls with an agency hazard classification, 19,020 are high severity, 64,468 moderate, and 4,513 low. A further 16,157 CPSC/NHTSA recalls have no agency class and are excluded from this split. This recall is classified moderate severity.
Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.
Affected scope
214
Related Recalls
6
6 from same agency
Product description
AquaBeam Handpiece, Sterile EO, Rx Only, REF: 310301, and 320301, a component of AquaBeam Robotic System. 320301 distributed outside the U.S. Device Description The AQUABEAM Robotic System is intended for use in patients suffering from lower urinary tract symptoms resulting from benign prostatic hyperplasia (BPH).
Reason for recall
Certain lots may develop an internal leak due to a micro-crack in a specific weld joint within the device. When the Robot detects this failure, it immediately renders the device inoperable and notifies the user via an error message, which may cause delay and/or inability to complete the procedure.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Terminated |
| Recall number | Z-1110-2019 |
| Date reported | April 17, 2019 |
| Date initiated | March 6, 2019 |
| Recalling firm | Procept Biorobotics Corporation |
| Firm location | Redwood City, CA |
| Affected scope | 214 |
| Distribution | Worldwide Distribution: US (nationwide) state to: TX, FL, IN, CA, IL, VA, MI, PA.; and (OUS) countries of: Italy, Germany, France, Poland, United Kingdom, Spain, Canada and Australia. |
Profile values are sourced directly from the official FDA Devices enforcement record. Source: U.S. Food and Drug Administration.
What to do with this recall
Match your product against the recall record, then act on the agency remedy.
- Check the recall number (Z-1110-2019) and product description against the item you own. Search the archive
- Confirm the current status with FDA Devices before acting, recall details can be updated.
- Follow the documented remedy (refund, replacement, repair, or disposal) rather than general advice. What to do next
This page summarizes the official FDA Devices record for research and awareness; it is not legal, medical, or safety advice. Verify with the issuing agency before acting.
Frequently Asked Questions
What product was recalled? ▼
AquaBeam Handpiece, Sterile EO, Rx Only, REF: 310301, and 320301, a component of AquaBeam Robotic System. 320301 distributed outside the U.S. Device Description The AQUABEAM Robotic System is intended for use in patients suffering from lower urinary tract symptoms resulting from benign prostatic hyperplasia (BPH).. Recalled by Procept Biorobotics Corporation. Units affected: 214.
Why was this product recalled? ▼
Certain lots may develop an internal leak due to a micro-crack in a specific weld joint within the device. When the Robot detects this failure, it immediately renders the device inoperable and notifies the user via an error message, which may cause delay and/or inability to complete the procedure.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on April 17, 2019. Severity: Moderate. Recall number: Z-1110-2019.
Where was the recalled product distributed? ▼
Distribution: Worldwide Distribution: US (nationwide) state to: TX, FL, IN, CA, IL, VA, MI, PA.; and (OUS) countries of: Italy, Germany, France, Poland, United Kingdom, Spain, Canada and Australia..
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-1110-2019) against your product. Visit the official FDA Devices website for the most current information. You can also use our Recall Checker tool to search by product name or brand.
Should I stop using a recalled medication or medical device? ▼
Do not stop using a recalled medication or device without consulting your healthcare provider first, as abruptly discontinuing treatment could pose its own health risks. Your doctor can advise on alternatives or whether the recall applies to your specific product lot. Check the recall number and lot information against your product packaging.
Nearby Recalls in This Category
Other recalls in the same product category, useful for spotting patterns across the same defect class or manufacturer.
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Compare this recall with FARADRIVE STEERABLE SHEATH CLEAR, used to facilitate access… →
Every figure on PlainRecalls is rendered directly from official FDA, CPSC and NHTSA recall records, no number is typed in by an editor. This recall: FDA Devices, reported April 17, 2019. Severity classes follow each agency's own taxonomy (FDA Class I/II/III; CPSC and NHTSA by hazard type), and related-recall context is computed across the full archive. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of August 2026.