Lumenis Limited: FDA recalls
FDA enforcement reports name Lumenis Limited as the recalling firm in 3 events. The events have 3 product records. The recalls started from 2013 to 2016. All the events are device recalls.
It is important to note that most of the time recall classifications are determined after the recalling firm provides all of the information needed to determine the risk posed to public health. The classification and posting in the FDA Enforcement Report should not be seen as an expansion or change to a firm’s voluntary public warning.
FDA publishes these words. Source: FDA, Enforcement Reports, Important Note, read on . openFDA export of .
Enforcement events
3 events, newest first.
| Initiated | Product (first record) | Type | Class | Records | Status |
|---|---|---|---|---|---|
| 25 Sep 2016 | FemTouch delivery system includes the FemTouch Kit (AC-1007415) and FemTouch" Tip (SPSA-20002590) Provide fractional treatments in gynecology. | Device | Class II | 1 | Terminated |
| 25 Mar 2015 | Light Sheer Desire Diode Laser System with XC Handpiece Accessory options. | Device | Class II | 1 | Terminated |
| 2 Jan 2013 | The Lumenis VersaCut Tissue Morcellator Product Usage: is intended for use under direct or endoscopic visualization for the morcellation and removal of dissected tissue during pelviscopic, laparoscopic, percutaneous, and open surgical procedures whenever access to the surgical site is limited. | Device | Class I | 1 | Terminated |
An event with 1 product record and a class that is not Class I has no page. It has a row in this table.
Enforcement event: All the product records that have one FDA event number. This site shows one event on one page.
Recalling firm: The firm that the FDA record names for a recall.
Follow by RSS:Food, drug and device recallsFDA Class I recalls
Type and class
| Type | Events |
|---|---|
| Device | 3 |
| Class | Events |
|---|---|
| Class II | 2 |
| Class I | 1 |
- Share of the events of the firm in Class I
- 33%
- Share of all events on the register in Class I
- 18%
- Events with the status Ongoing
- 0
openFDA, about the status: FDA does not update the status of a recall after the recall has been classified according to its level of hazard. As such, the status of a recall (open, completed, or terminated) will remain unchanged after published in the Enforcement Reports.
Source: openFDA, Drug Recall Enforcement Reports, Disclaimer.
Events by year
Official channels
- FDA enforcement reportsThe FDA search of the weekly enforcement reports.
- FDA: recalls, market withdrawals and safety alertsThe recall notices on the FDA site.
- FDA: report a problemThe FDA page that shows where a report about a product goes.
- FDA MedWatchThe FDA safety reporting program for drugs and medical devices.
Cite this page
Recall Register. Lumenis Limited: FDA recalls. https://recallregister.com/firm/lumenis-limited/. Source: openFDA enforcement reports. Data through .
Sources
- Source
- openFDA enforcement reports
- Licence
- CC0 1.0
- Export date
- 28 Sep 2026
The firm name is the spelling in the FDA records. A company with 2 spellings has 2 pages.
A firm with more products can have more recalls. This site does not compare one firm with a different firm. How the register is made. Report an error.
Questions
- Which classes do the FDA recalls of Lumenis Limited have?
- Class II: 2 events. Class I: 1 event. The class is for the product of a recall. It is not a class of the firm.
- What is the newest FDA recall of Lumenis Limited?
- FDA event 75384, which the firm started on 25 Sep 2016. The first product in the record is:
FemTouch delivery system includes the FemTouch Kit (AC-1007415) and FemTouch" Tip (SPSA-20002590) Provide fractional treatments in gynecology.
- How many FDA recalls of Lumenis Limited have the status Ongoing?
- No event has the status Ongoing in the openFDA file. openFDA says about the status:
FDA does not update the status of a recall after the recall has been classified according to its level of hazard. As such, the status of a recall (open, completed, or terminated) will remain unchanged after published in the Enforcement Reports.