Class II — Potential Health Hazard

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

Tranberg MR Stylet Recalled by CLINICAL LASERTHERMIA SYSTEMS AB Due to single use devices labeled as sterile may not...

Date: April 1, 2021
Company: CLINICAL LASERTHERMIA SYSTEMS AB
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 CLINICAL LASERTHERMIA SYSTEMS AB directly.

Affected Products

Tranberg MR Stylet, 1.8mm/15G, 230mm, REF: 4013-06, Rx Only, Sterile EO - Product Usage: used with the Tranberg¿ MR Introducer; a device used to aid the insertion of the Laser Applicator into the tissue.

Quantity: 40 units

Why Was This Recalled?

single use devices labeled as sterile may not have been adequately sterilized

Where Was This Sold?

This product was distributed nationwide across all 50 states.

Affected (51 states)Not affected

About CLINICAL LASERTHERMIA SYSTEMS AB

CLINICAL LASERTHERMIA SYSTEMS AB has 3 total recalls tracked by RecallDetector.

Related Recalls

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