The Recall Desk
HighFDA (Devices)·Z-0465-2022·Announced 2022-01-19

Subdermal Needle Electrode Corkscrew Recall: Risk of Blue Hub Detachment

Technomed Europe is recalling 117,672 disposable subdermal needle electrodes due to risk of the blue hub detaching, potentially leaving the needle in the patient's scalp.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: This is a Class II medical device recall involving a serious hazard (retained needle in scalp) that could result in patient injury. However, the source text does not report any illnesses or injuries. Per the rubric, risk-of-harm products where injury has not yet been reported score as High (3).

Plain-English summary

Technomed Europe has recalled 117,672 disposable subdermal needle electrodes, including model numbers TE/S50715-001-C, TE/S50725-001-C, and TE/S50715-001. These are single-use, sterile devices designed for subdermal electrode application using a corkscrew insertion mechanism.

The recall was initiated due to a high risk that the blue hub could detach from the corkscrew needle. If this detachment occurs, the needle may remain lodged in the patient's scalp, potentially causing injury.

The affected devices were distributed to facilities in California, Florida, and Ohio. Multiple lot numbers are included in this recall. For detailed information on affected lot numbers and the full recall, see FDA recall number Z-0465-2022.

The recalled product

Product
Disposable Subdermal Needle Electrode, Corkscrew, Single Use, Sterile; Model Numbers TE/S50715-001-C, TE/S50725-001C, and TE/S50715-001.
Manufacturer
Technomed Europe
Category
Medical Device — Electrodes
Hazard
  • retained-needle
  • component-detachment

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (20)

  • Read as "Lot Number (UDI-DI
  • Product Number)": 048565 (08718375861707
  • TE/S50715-004)
  • 048670 (08718375867549
  • TE/S50715-001-C)
  • 048949 (08718375867549
  • 049013 (08718375865439
  • SO-ELCS20)
  • 049014 (08718375867549
  • 049165 (08718375865439
  • 049166 (08718375867853
  • TE/S50725-001-C)
  • 049167 (08718375867549
  • 049188 (08718375861707
  • 049189 (08718375861707
  • 049190 (08718375861691
  • TE/S50715-003)
  • 049191 (08718375861684
  • TE/S50715-002)
  • 049192 (08718375861547

Distribution

Distributed nationwide across the United States.

Related recalls

Same category