Advanced Bionics, LLC
Complete recall history across all FDA and CPSC categories — 11 total recalls
Advanced Bionics, LLC appears in recall records across 1 category. This page consolidates all FDA food, drug, and medical device enforcement actions, plus CPSC consumer product recalls associated with this company. Recall data is sourced from openFDA and CPSC public databases.
Device Recalls (11)
FDA medical device enforcement actions by Advanced Bionics, LLC
| Date | Product | Reason | Class |
|---|---|---|---|
| Nov 27, 2025 | Brand Name: HiResolution Bionic Ear System Product Name: Sky CI M90 Sound Pr... | Behind-the-ear sound processer packaging label is different then included p... | Class II |
| Mar 5, 2025 | HiResolution" Bionic Ear System - M Battery Charger Model Number CI-5607 | Due to incorrect the battery charger being packaged and distributed. Product... | Class II |
| Sep 26, 2020 | AB PowerCel 230 (velvet black), REF: CI-5523-150, UDI: (01) 07630016832956 us... | Mislabeling; It has been determined that some batteries were improperly label... | Class III |
| Sep 26, 2020 | AB PowerCel 170 (velvet black), REF: CI-5517-150, UDI: (01) 07630016833113 us... | Mislabeling; It has been determined that some batteries were improperly label... | Class III |
| Feb 17, 2020 | AB HiResolution Bionic Ear System, HiRes Ultra 3D CI, HiFocus SlimJ Electrode... | hearing performance degradation due to body-fluid entering the device. | Class II |
| Feb 17, 2020 | AB HiResolution Bionic Ear System, HiRes Ultra CI, MS Electrode - Product Usa... | hearing performance degradation due to body-fluid entering the device. | Class II |
| Apr 4, 2019 | SoundWave Professional Suite Software 3.2, Ref CI-6055-014, SPN 058-023-32085... | The manufacturer received complaints that customers were attempting to instal... | Class III |
| Mar 18, 2019 | HiResolution Bionic Ear System HiRes 90K Advantage CI HiFocus MS Electrode RE... | Three materials used in the makeup of the implant were mistakenly left off th... | Class III |
| Feb 6, 2019 | Na¿da CL Q30 Sound Processor, Sand Beige, Model Cl-5260-120; Silver Gray, Mod... | The sound processors were loaded with the incorrect firmware. | Class II |
| Feb 6, 2019 | Na¿da CI Q90 Sound Processor, Silver Gray, Model Cl-5280-140. | The sound processors were loaded with the incorrect firmware. | Class II |
| Feb 6, 2019 | Na¿da CI Q70 Sound Processor, Sand Beige, Model Cl-5245-120; Silver Gray, Mod... | The sound processors were loaded with the incorrect firmware. | Class II |
Frequently Asked Questions
A high number of recalls does not necessarily indicate that a company is unsafe. Large manufacturers that produce thousands of products across multiple categories will statistically appear in recall databases more frequently. What matters more is the severity of each recall (Class I being the most serious), the speed of response, and whether the company proactively identified and addressed the issue. Companies with robust safety programs often catch problems earlier.
Food, drug, and medical device recall data comes from the FDA's openFDA enforcement database, which contains all FDA enforcement reports. Consumer product recall data comes from the U.S. Consumer Product Safety Commission (CPSC). Both sources are public government databases that are updated regularly. RecallCheck aggregates these sources to provide a unified view of a company's recall history.
The FDA classifies recalls into three categories. Class I is the most serious — there is a reasonable probability that use of or exposure to the product will cause serious adverse health consequences or death. Class II means the product may cause temporary or medically reversible health problems, or the probability of serious consequences is remote. Class III is the least serious — the product is unlikely to cause adverse health consequences. CPSC product recalls do not use this classification system.
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