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.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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
- Affected units
- 117,672
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
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