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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