Lower risk Medical device recall · FDA · Published April 1, 2021

Tranberg MR Stylet Recall: Sterile Devices May Not Be Adequately Sterilized

CLINICAL LASERTHERMIA SYSTEMS AB recalls Tranberg MR Stylets (REF: 4013-06) due to potential inadequate sterilization. These single-use sterile devices may not be properly sterilized, risking infection.

Plain-English summary generated from official FDA data by GovInfoNow · Published by Carlos Caban · How we make summaries

🇺🇸 FDA recall #Z-1781-2021Medical device CLINICAL LASERTHERMIA SYSTEMS AB ›

Lower-risk recall

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

Take action

Contact the company

Recalling firmCLINICAL LASERTHERMIA SYSTEMS ABScheelevagen 2 · Lund, Sweden

✎ GovInfoNow plain-language explainer

CLINICAL LASERTHERMIA SYSTEMS AB is recalling Tranberg MR Stylets (1.8mm/15G, 230mm, REF: 4013-06) because single-use devices labeled as sterile may not have been adequately sterilized. This could lead to infection if used improperly. Read more at govinfonow.com/recall/62860-tranberg-mr-stylet-recall-sterile-devices-may-not-be-adequately.

Source Summary by GovInfoNow · govinfonow.com/recall/62860-tranberg-mr-stylet-recall-sterile-devices-may-not-be-adequately · Updated August 19, 2026 · FDA enforcement record: FDA #Z-1781-2021

Cite this page

“Tranberg MR Stylet Recall: Sterile Devices May Not Be Adequately Sterilized.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/62860-tranberg-mr-stylet-recall-sterile-devices-may-not-be-adequately. Based on FDA recall #Z-1781-2021 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1781-2021%22&limit=1).

CLINICAL LASERTHERMIA SYSTEMS AB recalled Tranberg MR Stylet units because single-use devices labeled as sterile may not have been adequately sterilized, according to the FDA on April 1, 2021.

How to tell if you have it

Tranberg MR Stylet, 1.8mm/15G, 230mm
REF: 4013-06
Lot ID: 116540030718
Lot ID: 116540201117

The hazard

The recall involves Tranberg MR Stylet devices used with the Tranberg MR Introducer. The hazard is that single-use devices labeled as sterile may not have been adequately sterilized.

Context

GovInfoNow's records show other recent recalls of similar products include Medline Convenience Kits Recall: Risk of Contaminated Sterile Products (2026-01-07) and Argon Medical Devices General Biospy Tray Recall: Sterility Risk (2026-06-01). Another related recall was the Medline Convenience Kits: Risk of Contaminated Sterilized Products issued on 2026-01-07.

How to tell if you have this one

Check for the product name 'Tranberg MR Stylet', model 1.8mm/15G, 230mm, and reference number 4013-06. These stylets are used with the Tranberg MR Laser System and are labeled as sterile.

Brand
CLINICAL LASERTHERMIA SYSTEMS AB
Category
Medical device

FDA recall event · 3 products

All 3 products in this recall

FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.

Classification
Class II
Status
Terminated
Distribution
Worldwide distribution - US Nationwide distribution in the states of TX, MD, CA and the countries of Canada, Germany, Switzerland.

Recall number	Product, codes & lots	Quantity
Z-1780-2021	Tranberg MR Cannula, REF: 4013-05, 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.; Lot ID: 116539201117 and 116539030718 M	40 units
Z-1781-2021	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.; Lot ID: 116540030718, 116540201117	40 units
Z-1782-2021	Tranberg Laser Applicator Non-cooled, 1.7mm/ 15G, 15 mm, Diffuser, 12 m, REF: 4017-02, 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.; Lot # 00247/2019/11, 00029/2020/02, 00076/2020/03, 00177/2018/10-1, 00177/2018/10-2, 00049/2020/02	90 units

Based on the official FDA remedy

What to do — step by step

Check Product Details
Look for the product name, model, and reference number on the stylet packaging or label.

Where it went and when

Where it was distributed

Distributed nationwide and abroad; the notice names 3 states.

FDA distribution: “Worldwide distribution - US Nationwide distribution in the states of TX, MD, CA and the countries of Canada, Germany, Switzerland.” States read from FDA’s own wording; “not listed” means the notice does not name it.

Named in the notice: California, Maryland, Texas.

Recall timeline

FDA terminated this recall 2.4 years after the firm started it.

Apr 1, 2021Firm started the recall
Jun 3, 2021FDA classified it Class II
Jun 9, 2021Published in FDA’s Enforcement Report
Aug 30, 2023FDA terminated the recall

Dates from the agency record only; steps without a date are left out.

Similar recalls

Latest medical device recalls

Keep exploring

More CLINICAL LASERTHERMIA SYSTEMS AB recalls

Link to this recall

<a href="https://govinfonow.com/recall/62860-tranberg-mr-stylet-recall-sterile-devices-may-not-be-adequately">Tranberg MR Stylet Recall: Sterile Devices May Not Be Adequately Sterilized (GovInfoNow)</a>

Where this comes from

The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.

Official source: FDA Recall #Z-1781-2021 (April 1, 2021) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1781-2021 to see it in context.
Plain-language summary written by qwen3:4b on August 19, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.