Technomed Europe FDA Recalls

3 recalls on file across devices, 0 of them Class I and 1 still open. This firm is not matched to a listed company.

Newest first

Class I is the FDA's most serious grade: a reasonable probability of serious harm or death.

Product	Reason	Class	Initiated
NEUROSIGN Disposable Stimulating Dissector, REF 5888-00Class IIJul 25, 2024Product has have presence of brown discoloration or substanc	Product has have presence of brown discoloration or substance on the hinge area of the device	Class IIDevices	Jul 25, 2024
Disposable Subdermal Needle Electrode, Pt/lr, 12 x 0.40mm, product number TE/S46/638, 25 needles per package, sterile.Class IIAug 9, 2022Burns of varying degrees can occur to patients with electrod	Burns of varying degrees can occur to patients with electrodes left in while in the MRI scanner as a result of	Class IIDevices	Aug 9, 2022
Disposable Subdermal Needle Electrode, Corkscrew, Single Use, Sterile; Model Numbers TE/S50715-001-C, TE/S50725-001C, anClass IIDec 8, 2021There is a high risk of the blue hub detaching from the cork	There is a high risk of the blue hub detaching from the corkscrew needle, resulting the the needle remaining i	Class IIDevices	Dec 8, 2021