Use caution Medical device recall · FDA · Published February 3, 2021

Somatex Thread-like Wire Marker Recall: Risk of Wire Splintering During Lesion Removal

Somatex recalls thread-like wire markers that may splinter during lesion removal, risking retained fragments inside the body. Affected lots include specific reference numbers for Tuflex and Tuflex Premium products.

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

🇺🇸 FDA recall #Z-1200-2021Medical device Somatex ›

Use caution until it’s fixed

This recall has been initiated due to the risk of wire splintering after contact with a cautery device during the removal of a lesion. There is a potential risk that wire fragments are not removed during the procedure and stays inside the patient's body.

Take action

Contact the company

Recalling firmSomatex Medical Technologies GMBHHohenzollerndamm 150-151 · Berlin, Germany

✎ GovInfoNow plain-language explainer

Somatex is recalling thread-like wire markers that could splinter when used with cautery devices during lesion removal. This poses a risk of wire fragments staying inside the patient's body after surgery. Read more at govinfonow.com/recall/63317-somatex-thread-like-wire-marker-recall-risk-of-wire-splintering.

Source Summary by GovInfoNow · govinfonow.com/recall/63317-somatex-thread-like-wire-marker-recall-risk-of-wire-splintering · Updated August 19, 2026 · FDA enforcement record: FDA #Z-1200-2021

Cite this page

“Somatex Thread-like Wire Marker Recall: Risk of Wire Splintering During Lesion Removal.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/63317-somatex-thread-like-wire-marker-recall-risk-of-wire-splintering. Based on FDA recall #Z-1200-2021 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1200-2021%22&limit=1).

The FDA announced on Feb. 3, 2021, that Somatex Medical Technologies GMBH voluntarily recalled Thread-like wire markers due to the risk of wire splintering during lesion removal. The agency classified this Class II recall as terminated.

How to tell if you have it

Brand: Somatex
Product: Tuflex (REF 271640, lots 51268 and 51414; REF 271641, lots 51269 and 51410; REF 271642, lots 51270 and 51411; REF 271643, lots 51271 and 51412)
Product: Tuflex Premium (REF 271650, lot 51300; REF 271651, lots 51299 and 51413; REF 271652, lot 51301)
Distribution: Missouri, New Jersey, Ohio
Units affected: 196 pieces

The hazard

The recall addresses the risk of wire splintering after contact with a cautery device during lesion removal. There is a potential risk that wire fragments are not removed during the procedure and stay inside the patient's body.

Context

GovInfoNow's records show other recent recalls of similar products include Wilson-Cook Teslatome Sphincterotomes Recall (2025-12-18), Medline Livewire Steerable Catheters Recall (2025-12-22), and da Vinci S/Si Cautery Hook Recall (2025-12-09).

How to tell if you have this one

Check the reference numbers on the product packaging: Tuflex has REF 271640-271643 and Tuflex Premium has REF 271650-271652. Affected lots are listed for each reference number.

Brand
Somatex
Category
Medical device

Based on the official FDA remedy

What to do — step by step

Check Product Details
Review the reference numbers on the product packaging to determine if it is in the affected lots listed for Tuflex or Tuflex Premium.

Where it went and when

Where it was distributed

Distributed in 3 states.

FDA distribution: “Domestic: Mo, NJ, OH” States read from FDA’s own wording; “not listed” means the notice does not name it.

States: Missouri, New Jersey, Ohio.

Recall timeline

FDA terminated this recall 11 months after the firm started it.

Feb 3, 2021Firm started the recall
Mar 10, 2021FDA classified it Class II
Mar 17, 2021Published in FDA’s Enforcement Report
Jan 13, 2022FDA terminated the recall

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

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Link to this recall

<a href="https://govinfonow.com/recall/63317-somatex-thread-like-wire-marker-recall-risk-of-wire-splintering">Somatex Thread-like Wire Marker Recall: Risk of Wire Splintering During Lesion Removal (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-1200-2021 (February 3, 2021) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1200-2021 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.