Class II — Potential Health Hazard

Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.

FemTouch delivery system includes the FemTouch Kit (AC-1007415) and FemTouch" Recalled by Lumenis Limited Due to The cleaning instructions provided in FemTouch Operator's Manual...

Date: September 25, 2016
Company: Lumenis Limited
Status: Terminated
Source: FDA (Device)

What You Should Do

Stop using this product immediately. Do not consume, use, or distribute it.

Return the product to the place of purchase for a full refund. If you have questions, contact Lumenis Limited directly.

Affected Products

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

Quantity: 69 units

Why Was This 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.

Where Was This Sold?

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

About Lumenis Limited

Lumenis Limited has 3 total recalls tracked by RecallDetector.

Related Recalls

Data sourced from the FDA (Device). Last updated March 26, 2026. View original report