Stop using now Medical device recall · FDA · Published December 8, 2021

Technomed Disposable Subdermal Needle Electrode Recall: Blue Hub May Detach Causing Scalp

Technomed recalls disposable subdermal needle electrodes with a risk of blue hub detaching, leaving needles in scalp. Affected models include TE/S50715-001-C and others. Stop using immediately.

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

🇺🇸 FDA recall #Z-0465-2022Medical device Technomed ›

Stop using this now

There is a high risk of the blue hub detaching from the corkscrew needle, resulting the the needle remaining in the patient's scalp.

Take action

Contact the company

Recalling firmTechnomed EuropeAmerikalaan 71 · Maastricht-Airport, Netherlands

✎ GovInfoNow plain-language explainer

Technomed is recalling disposable subdermal needle electrodes that may have a blue hub detaching from the needle, potentially leaving it in the patient's scalp. This poses a serious injury risk if the needle remains embedded. Read more at govinfonow.com/recall/61452-technomed-disposable-subdermal-needle-electrode-recall-blue-hub-may-detach.

Source Summary by GovInfoNow · govinfonow.com/recall/61452-technomed-disposable-subdermal-needle-electrode-recall-blue-hub-may-detach · Updated August 19, 2026 · FDA enforcement record: FDA #Z-0465-2022

Cite this page

“Technomed Disposable Subdermal Needle Electrode Recall: Blue Hub May Detach Causing Scalp.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/61452-technomed-disposable-subdermal-needle-electrode-recall-blue-hub-may-detach. Based on FDA recall #Z-0465-2022 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0465-2022%22&limit=1).

The FDA announced on 2021-12-08 that Technomed Europe is recalling Disposable Subdermal Needle Electrodes due to a high risk of the blue hub detaching from the corkscrew needle. This defect can result in the needle remaining in the patient's scalp. The agency classified this as a Class II recall.

How to tell if you have it

Brand: Technomed
Product: Disposable Subdermal Needle Electrode, Corkscrew, Single Use, Sterile
Model Numbers: TE/S50715-001-C, TE/S50725-001C, TE/S50715-001
Lot Numbers: 048565, 048670, 048949, 049013, 049014, 049165, 049166, 049167, 049188, 049189, 049190, 049191, 049192, 049193, 049328, 049343, 049429, 049443, 049502, 049528, 049549, 049552, 049603, 049662, 049710, 049735, 049736, 049802, 049847, 049855, 049858, 049861, 049871, 049878, 049924, 049925, 049932, 049955, 049969, 049970, 049982, 049989, 049990, 050077, 050106, 050136, 050240, 050395, 050715
Units Affected: 117,672 devices

The hazard

There is a high risk of the blue hub detaching from the corkscrew needle. This results in the needle remaining in the patient's scalp.

Context

GovInfoNow's records show Technomed Europe has 2 other recalls on record since 2022-08-09. On 2024-07-25, Technomed Europe issued a recall for NEUROSIGN Disposable Stimulating Dissector due to brown discoloration hazards. On 2022-08-09, the brand recalled Disposable Subdermal Needles over MRI burn risks. Other recent recalls of similar products include Medline Medical Convenience Kits Recall (2026-02-27) and Medline Medical Kits Recall (2026-02-27).

How to tell if you have this one

Check for model numbers TE/S50715-001-C, TE/S50725-001C, and TE/S50715-001 in the product description. The product is a disposable subdermal needle electrode used for medical procedures.

Brand
Technomed
Category
Medical device

Based on the official FDA remedy

What to do — step by step

Stop Using Immediately
Discontinue use of the recalled disposable subdermal needle electrodes if you have them.

Where it went and when

Where it was distributed

Distributed nationwide; the notice names 3 states.

FDA distribution: “US Nationwide distribution in the states of California, Florida, and Ohio.” States read from FDA’s own wording; “not listed” means the notice does not name it.

Named in the notice: California, Florida, Ohio.

Recall timeline

FDA terminated this recall 2.5 years after the firm started it.

Dec 8, 2021Firm started the recall
Jan 7, 2022FDA classified it Class II
Jan 19, 2022Published in FDA’s Enforcement Report
May 31, 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/61452-technomed-disposable-subdermal-needle-electrode-recall-blue-hub-may-detach">Technomed Disposable Subdermal Needle Electrode Recall: Blue Hub May Detach Causing Scalp (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-0465-2022 (December 8, 2021) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0465-2022 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.