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Nucleus

COCHLEAR LIMITED · Model Z146125 · UDI-DI 09321502012249

MCM Prescription
0
510(k) clearances
75,022
Adverse events (68 deaths)
32
Recalls
23
Facilities

Description

NUCLEUS FREEDOM N22 COIL, 8CM, BLK

Recalls

DateFirmReason
2026-04-30Advanced Bionics, LLCDue to incorrect shelf-life expiration date.
2026-03-23Advanced Bionics, LLCThe non-tamperproof battery door supplied with the sound processor fails to conform to IEC 60601-1-11:2015 by not requiring the use of a tool to replace the button/coin cell batter
2025-11-27Advanced Bionics, LLCBehind-the-ear sound processer packaging label is different then included product.
2025-03-05Advanced Bionics, LLCDue to incorrect the battery charger being packaged and distributed. Product labeling does not match the intended product as specified.
2024-04-18MED-EL Elektromedizinische Gereate, GmbhA 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.
2024-04-08MEDLINE INDUSTRIES, LP - NorthfieldMedical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/ other quality issues have been identified that ma
2020-09-26Advanced Bionics, LLCMislabeling; It has been determined that some batteries were improperly labeled and may contain a different battery life than indicated.
2020-09-26Advanced Bionics, LLCMislabeling; It has been determined that some batteries were improperly labeled and may contain a different battery life than indicated.
2020-02-17Advanced Bionics, LLChearing performance degradation due to body-fluid entering the device.
2020-02-17Advanced Bionics, LLChearing performance degradation due to body-fluid entering the device.

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Data compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.