MED-EL Elektromedizinische Gereate, Gmbh: Medical Device Recall in 2024 - (Recall #: Z-2356-2024)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2024.

Data Source: FDA.

Product Description:

Mi1250 SYNCHRONY 2, Item Numbers: a) 39541, FLEXSOFT S-Vector; b) 39545, FLEX28 S-Vector; c) 39547, FLEX26 S-Vector; Cochlear Implant

Product Classification:

Class II

Date Initiated: April 18, 2024

Date Posted: July 24, 2024

Recall Number: Z-2356-2024

Event ID: 94531

Reason for Recall:

A small number of devices may have a higher probability of a crack within the internal electronics substrate which could result in a non-functional device.

Status: Ongoing

Product Quantity: 7 devices

Code Information:

a) 39541, UDI/DI 09008737395414, Serial Numbers: 859106; b) 39545, UDI/DI 09008737395452, Serial Numbers: 860731, 860782, 863380; c) 39547, UDI/DI 09008737395476, Serial Numbers: 860757, 860772, 863386

Distribution Pattern:

US, Durham, NC

Voluntary or Mandated:

Voluntary: Firm initiated