Class II — Potential Health Hazard

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

Quanta System Sterile Optical Laser Fiber Recalled by Quanta System, S.p.A. Due to Product sterility is potentially compromised.

Date: April 27, 2021
Company: Quanta System, S.p.A.
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 Quanta System, S.p.A. directly.

Affected Products

Quanta System Sterile Optical Laser Fiber, single use

Quantity: 2427 units

Why Was This Recalled?

Product sterility is potentially compromised.

Where Was This Sold?

This product was distributed nationwide across all 50 states.

Affected (51 states)Not affected

About Quanta System, S.p.A.

Quanta System, S.p.A. has 6 total recalls tracked by RecallDetector.

Related Recalls

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