FDA DeviceClass IINotable

FDA Recall: Brand Name: HiResolution Bionic Ear System Product Name: Sky CI M90 Sound Processor Model/Catalog

Date: 2026-03-11
Brand: Advanced Bionics, LLC
Category: Medical Device
FDA Class: Class II

Description

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

Hazard

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

Remedy

2 units

View original recall →
Share:

Related Recalls

2026-05-06 · FDA_DEVICE
FDA Recall: Medline medical procedure kits, containing Medline Neuro Sponges (4077 in total), LAMINECTOMY, CRANI
Medline Industries, LP
2026-05-06 · FDA_DEVICE
FDA Recall: VACUUM BAG SU LARGE, Non-sterile specimen container, Model/Catalog Number: 68409SS
Milestone S.R.L.
2026-05-06 · FDA_DEVICE
FDA Recall: Medline medical procedure kits, containing Medline Neuro Sponges, labeled as follows: 1. PLASTICS
Medline Industries, LP
2026-05-06 · FDA_DEVICE
FDA Recall: WHILL Model F, with software versions before HMI: 2.23 / MC: 1.05; the device is an indoor/outdoor,
WHILL, INC.