Lumenis Limited: Medical Device Recall in 2016 - (Recall #: Z-0301-2017)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2016.

Data Source: FDA.

Product Description:

FemTouch delivery system includes the FemTouch Kit (AC-1007415) and FemTouch" Tip (SPSA-20002590) Provide fractional treatments in gynecology.

Product Classification:

Class II

Date Initiated: September 25, 2016

Date Posted: November 2, 2016

Recall Number: Z-0301-2017

Event ID: 75384

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.

Status: Terminated

Product Quantity: 69 units

Code Information:

All serial numbers

Distribution Pattern:

Worldwide Distribution -- USA, Italy, Russian Fed., Australia, United Arab Emirates, Spain, United Kingdom, India, Kuwait, and Belarus.

Voluntary or Mandated:

Voluntary: Firm initiated