Advanced Bionics, LLC: Medical Device Recall in 2026 - (Recall #: Z-1493-2026)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2026.

Data Source: FDA.

Product Description:

Brand Name: HiResolution Bionic Ear System Product Name: Sky CI M90 Sound Processor Model/Catalog Number: CI-5295-150

Product Classification:

Class II

Date Initiated: November 27, 2025

Date Posted: March 11, 2026

Recall Number: Z-1493-2026

Event ID: 98161

Reason for Recall:

Behind-the-ear sound processer packaging label is different then included product.

Status: Ongoing

Product Quantity: 2 units

Code Information:

Lot Code: UDI-DI: 08400944CI5295YJ Model Number: CI-5295-150 Serial Numbers: 249596, 249603

Distribution Pattern:

Unknown

Voluntary or Mandated:

Voluntary: Firm initiated