Use caution Medical device recall · FDA · Published August 9, 2022

Technomed Europe Disposable Subdermal Needles: MRI Burn Risk

Technomed Europe recalls disposable subdermal needle electrodes with potential MRI burns due to inadequate safety info. Affected lots expire by 2024; stop using if used in MRI.

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

🇺🇸 FDA recall #Z-1737-2022Medical device Technomed Europe ›

Use caution until it’s fixed

Burns of varying degrees can occur to patients with electrodes left in while in the MRI scanner as a result of inadequate safety information in the IFU.

Take action

Contact the company

Recalling firmTechnomed EuropeAmerikalaan 71 · Maastricht-Airport, Netherlands

✎ GovInfoNow plain-language explainer

Technomed Europe is recalling disposable subdermal needle electrodes that could cause burns during MRI scans because the safety instructions were incomplete. This affects patients who have these electrodes left in place while undergoing MRI. Read more at govinfonow.com/recall/60202-technomed-europe-disposable-subdermal-needles-mri-burn-risk.

Source Summary by GovInfoNow · govinfonow.com/recall/60202-technomed-europe-disposable-subdermal-needles-mri-burn-risk · Updated August 19, 2026 · FDA enforcement record: FDA #Z-1737-2022

Cite this page

“Technomed Europe Disposable Subdermal Needles: MRI Burn Risk.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/60202-technomed-europe-disposable-subdermal-needles-mri-burn-risk. Based on FDA recall #Z-1737-2022 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1737-2022%22&limit=1).

The FDA announced on August 9, 2022, that Technomed Europe is recalling Disposable Subdermal Needle Electrodes due to a risk of patient burns during MRI scans. The agency stated the hazard stems from inadequate safety information in the instructions for use.

How to tell if you have it

Brand: Technomed Europe
Product: Disposable Subdermal Needle Electrode, Pt/lr, 12 x 0.40mm
Product number: TE/S46/638
Package size: 25 needles per package, sterile
Lot numbers: 044220 (exp. 1/1/2023), 045077 (exp. 3/1/2023), 045443 (exp. 4/1/2023), and 049285 (exp. 7/1/2024)
UDI-DI: 08718375861530
Quantity: 37/25-electrode boxes
Distribution: US Nationwide in CA, FL, NH, OH, and WA

The hazard

According to the FDA, burns of varying degrees can occur to patients with electrodes left in while in the MRI scanner as a result of inadequate safety information in the IFU.

Context

GovInfoNow's records show Technomed Europe has 2 other recalls on record since 2021-12-08. Other recent recalls include the Technomed Europe NEUROSIGN Disposable Stimulating Dissector Recall (2024-07-25) and the Technomed Disposable Subdermal Needle Electrode Recall (2021-12-08). Similar recent recalls of other products include the I.T.S. GmbH Pelvic Reconstruction System: MRI Safety Risk, the I.T.S. DUL/UOL Systems Risk MRI Heating - Recall, and the I.T.S. Headless Compression Screws: MRI Safety Risk (all 2026-01-23).

How to tell if you have this one

Check for lot numbers 044220 (exp. 1/1/2023), 045077 (exp. 3/1/2023), 045443 (exp. 4/1/2023), or 049285 (exp. 7/1/2024) on the packaging. The product is a sterile disposable subdermal needle electrode with 25 needles per package.

Brand
Technomed Europe
Category
Medical device

Based on the official FDA remedy

What to do — step by step

Check Product Lot Number
Look for lot numbers 044220, 045077, 045443, or 049285 on the packaging.
Stop Using if Used in MRI
If you used this electrode during an MRI scan, stop using it immediately and contact your healthcare provider.

Where it went and when

Where it was distributed

Distributed nationwide; the notice names 5 states.

FDA distribution: “US Nationwide distribution in the states of CA, FL, NH, OH, and WA.” States read from FDA’s own wording; “not listed” means the notice does not name it.

Named in the notice: California, Florida, New Hampshire, Ohio, Washington.

Recall timeline

FDA terminated this recall 20 months after the firm started it.

Aug 9, 2022Firm started the recall
Sep 12, 2022FDA classified it Class II
Sep 21, 2022Published in FDA’s Enforcement Report
Apr 11, 2024FDA 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/60202-technomed-europe-disposable-subdermal-needles-mri-burn-risk">Technomed Europe Disposable Subdermal Needles: MRI Burn Risk (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-1737-2022 (August 9, 2022) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1737-2022 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.