CLASS II Device recall · Reported 2 Nov 2016 · FDA Enforcement Report
FemTouch delivery system includes the FemTouch Kit recalled by Lumenis
Lumenis is recalling FemTouch delivery system includes the FemTouch Kit (AC-1007415) and FemTouch" Tip. The recall was initiated on 25 Sep 2016 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-0301-2017
- FDA event ID
- 75384
- Recalling firm
- Lumenis, Yokneam
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 25 Sep 2016
- FDA classified
- 23 Oct 2016
- Reported
- 2 Nov 2016
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Device type
- Other Medical Devices
Timeline
| 25 Sep 2016 | Recall initiated by company | |
| 23 Oct 2016 | Classified by FDA | +28 days |
| 2 Nov 2016 | Published in enforcement report | +10 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
The cleaning instructions provided in FemTouch Operator's Manual might be ineffective for a fully assembled device and may lead to a potential for cross-contamination.
Product as listed by the FDA
FemTouch delivery system includes the FemTouch Kit (AC-1007415) and FemTouch" Tip (SPSA-20002590) Provide fractional treatments in gynecology.
Where it was distributed
Worldwide Distribution -- USA, Italy, Russian Fed., Australia, United Arab Emirates, Spain, United Kingdom, India, Kuwait, and Belarus.
Questions about this recall
Why was it recalled?
The cleaning instructions provided in FemTouch Operator's Manual might be ineffective for a fully assembled device and may lead to a potential for cross-contamination.
Which lots are affected?
All serial numbers
Where was it sold?
Worldwide Distribution -- USA, Italy, Russian Fed., Australia, United Arab Emirates, Spain, United Kingdom, India, Kuwait, and Belarus.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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