FDA device enforcement
NEUROSIGN Disposable Stimulating Dissector, REF 5888-00
Product has have presence of brown discoloration or substance on the hinge area of the device
Class IIReported ongoing
Distribution: US: FL, CA, TX, IL, NY, PA, MA
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Technomed Europe recall records
1 reported ongoing
3 records in this archive. Latest source date Jul 25, 2024.
FDA enforcement status can lag behind the recall lifecycle. An empty search or a reported termination is not a personal product-safety determination.
Archive changed Oct 1, 2026. USDA FSIS records are unavailable; check FSIS directly. Source coverage and dates.
Records and reported status
Official source for NEUROSIGN Disposable Stimulating Dissector, REF 5888-00
FDA device enforcement
Disposable Subdermal Needle Electrode, Pt/lr, 12 x 0.40mm, product number TE/S46/638, 25 needles per package, sterile.
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.
Class IIReported terminated
Distribution: US Nationwide distribution in the states of CA, FL, NH, OH, and WA.
FDA device enforcement
Disposable Subdermal Needle Electrode, Corkscrew, Single Use, Sterile; Model Numbers TE/S50715-001-C, TE/S50725-001C, and TE/S50715-001.
There is a high risk of the blue hub detaching from the corkscrew needle, resulting the the needle remaining in the patient's scalp.
Class IIReported terminated
Distribution: US Nationwide distribution in the states of California, Florida, and Ohio.
Reasons in these listed records
- Product has have presence of brown discoloration or substance on the hinge area of the device
- 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.
- There is a high risk of the blue hub detaching from the corkscrew needle, resulting the the needle remaining in the patient's scalp.
These examples come from this result page and are not a ranking of every recall reason.
Checking Technomed Europe
Is there a recall on technomed europe right now?
This archive contains 3 records, including 1 with agency-reported ongoing status. The status field can be incomplete or stale. Open the current official notice and match your exact product.
How do I check my package or product?
Compare the product, firm and lot, date, model or serial identifiers with the notice. Use the label-check guide if you need help locating an identifier.
Does a matching name mean every item is included?
A name is a search match. The agency notice sets the affected products and identifiers. Do not assume that every item with the same name or brand belongs to the recall.
What if the search finds no matching record?
This search has source and keyword limits. Missing records or a missing lot code do not establish that a product is unaffected. Check source coverage and the agency's current notices.
Where can I find older records?
Use monthly archives or the local search. The initial import covers records dated from October 2021 where available; each source's actual first and latest dates appear on the coverage page.