Browse Device Recalls
11 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 11 FDA medical device recall enforcement actions. Each entry includes the device description, reason for recall, classification (Class I through III based on severity), recalling firm, and distribution details. Use the filters below to search by year, classification, state, or keyword.
Medical Device Recalls
Browse 11 FDA device recalls.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| 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 product. | Class II | Advanced Bionics, LLC |
| 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 labeling does not m... | Class II | Advanced Bionics, LLC |
| 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 labeled and may contain a... | Class III | Advanced Bionics, LLC |
| 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 labeled and may contain a... | Class III | Advanced Bionics, LLC |
| 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 | Advanced Bionics, LLC |
| 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 | Advanced Bionics, LLC |
| 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 install the fitting softwa... | Class III | Advanced Bionics, LLC |
| 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 the list of bio-compat... | Class III | Advanced Bionics, LLC |
| 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 | Advanced Bionics, LLC |
| 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 | Advanced Bionics, LLC |
| 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 | Advanced Bionics, LLC |
Frequently Asked Questions
When a device safety issue is identified, the manufacturer or FDA initiates a recall. The FDA publishes an enforcement report detailing the device, the reason for the recall, and distribution. Healthcare facilities and providers are notified to check their inventory and take corrective action.
All types — from simple devices like blood glucose test strips and surgical gloves to complex devices like pacemakers, defibrillators, insulin pumps, hip implants, and ventilators. Software-driven devices are increasingly common in recalls due to bugs and cybersecurity vulnerabilities.
Use the search and filter tools on this page. Each recall entry includes the device description, model numbers, and distribution details so you can determine if your device is affected. Contact your healthcare provider if you find a match.