Technomed Europe: Medical Device Recall in 2022 - (Recall #: Z-1737-2022)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2022.

Data Source: FDA.

Product Description:

Disposable Subdermal Needle Electrode, Pt/lr, 12 x 0.40mm, product number TE/S46/638, 25 needles per package, sterile.

Product Classification:

Class II

Date Initiated: August 9, 2022

Date Posted: September 21, 2022

Recall Number: Z-1737-2022

Event ID: 90733

Reason for Recall:

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.

Status: Terminated

Product Quantity: 37/25-electrode boxes

Code Information:

Lot numbers 044220, exp. 1/1/2023; 045077, exp. 3/1/2023; 045443, exp. 4/1/2023; and 049285, exp. 7/1/2024; UDI-DI 08718375861530.

Distribution Pattern:

US Nationwide distribution in the states of CA, FL, NH, OH, and WA.

Voluntary or Mandated:

Voluntary: Firm initiated