Recall Z-1493-2026 ยท MCM Implant, Cochlear
Advanced Bionics, LLC
Brand Name: HiResolution Bionic Ear System Product Name: Sky CI M90 Sound Processor Model/Catalog Number: CI-5295-150
| Date | Mar 5, 2026 (initiated Nov 27, 2025) |
| Status | Open, Classified |
| Reason | Behind-the-ear sound processer packaging label is different then included product. |
| Root cause | Under Investigation by firm |
| Action | On November 27, 2025, Advanced Bionics issued a recall notification to affected consignees via Email. Advanced Bionics ask consignees to take the following actions: Consignees to contact UK customer service to initiate the exchange of the mislabeled product with the correct product. Acknowledge receipt and understanding of the recall communication. |
| Quantity | 2 units |
| Distribution | Unknown |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.