Reported Jan 19, 2022 · Terminated

Disposable Subdermal Needle Electrode, Corkscrew, Single Use, Sterile; Model Numbers TE/S50715-001-C, TE/S50725-001C,…

Technomed Europe

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Technomed Europe · Amerikalaan 71 · Maastricht-Airport, N/A · N/A

Is this the product you have?

  • Disposable Subdermal Needle Electrode, Corkscrew, Single Use, Sterile; Model Numbers TE/S50715-001-C, TE/S50725-001C, and TE/S50715-001.
Lot codes and dates
  • 263 of 263 codes

    • Read as "Lot Number (UDI-DI
    • Product Number)": 048565 (08718375861707
    • TE/S50715-004)
    • 048670 (08718375867549
    • TE/S50715-001-C)
    • 048949 (08718375867549
    • TE/S50715-001-C)
    • 049013 (08718375865439
    • SO-ELCS20)
    • 049013 (08718375865439
    • SO-ELCS20)
    • 049014 (08718375867549
    • TE/S50715-001-C)
    • 049014 (08718375867549
    • TE/S50715-001-C)
    • 049165 (08718375865439
    • SO-ELCS20)
    • 049166 (08718375867853
    • TE/S50725-001-C)
    • 049166 (08718375867853
    • TE/S50725-001-C)
    • 049166 (08718375867853
    • TE/S50725-001-C)
    • 049166 (08718375867853
    • TE/S50725-001-C)
    • 049167 (08718375867549
    • TE/S50715-001-C)
    • 049167 (08718375867549
    • TE/S50715-001-C)
    • 049167 (08718375867549
    • TE/S50715-001-C)
    • 049167 (08718375867549
    • TE/S50715-001-C)
    • 049188 (08718375861707
    • TE/S50715-004)
    • 049188 (08718375861707
    • TE/S50715-004)
    • 049188 (08718375861707
    • TE/S50715-004)
    • 049188 (08718375861707
    • TE/S50715-004)
    • 049188 (08718375861707
    • TE/S50715-004)
    • 049188 (08718375861707
    • TE/S50715-004)
    • 049189 (08718375861707
    • TE/S50715-004)
    • 049189 (08718375861707
    • TE/S50715-004)
    • 049189 (08718375861707
    • TE/S50715-004)
    • 049189 (08718375861707
    • TE/S50715-004)
    • 049189 (08718375861707
    • TE/S50715-004)
    • 049190 (08718375861691
    • TE/S50715-003)
    • 049190 (08718375861691
    • TE/S50715-003)
    • 049190 (08718375861691
Amount recalled
117,672 devices

Where it was sold

Why it was recalled

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

This product could cause temporary or reversible health problems — stop using it.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Notice updated May 31, 2024 · Data as of Sep 19, 6:17 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.