Advanced Bionics, LLC recalls Brand Name: HiResolution" Bionic Ear System Product Name: M Zn-Air Battery Pak Model/Catalog Number: CI-5501-110; CI-5501-120;…
The 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 battery.
Read the official notice →- Date
- 2026-05-06
- Country
- United States
- Brand
- Advanced Bionics
- Product
- Brand Name: HiResolution" Bionic Ear System Product Name: M Zn-Air Battery Pak Model/Catalog Number: CI-5501-110; CI-5501-120;…
- Classification
- Class II
- Units
- Worldwide - U.S Nationwide distribution including in the state of AK, AL, AR,…
- Category
- Drugs & medical
- Source
- FDA · Device
Copied automatically from the US Food and Drug Administration. Details may be shortened or out of date; the official notice is the authoritative source. Disclaimer
What to do
- Check the product name, strength and lot number against the official notice.
- Do not stop a prescribed medicine without talking to your doctor or pharmacist first.
- Ask the pharmacy or supplier about a replacement or refund.
General guidance from Recall Atlas. The official notice from the US Food and Drug Administration has the exact models, batch codes and remedy, and it takes priority.
More Advanced Bionics recalls
- 2026-06-10
USAdvanced Bionics, LLC recalls Brand Name: HiResolution" Bionic Ear System Product Name: HiRes Ultra 3D CI HiFocus Mid Scala Model/Catalog Number: CI-1601-04 Software…
Due to incorrect shelf-life expiration date.
FDA · DeviceAdvanced Bionics, LLCU.S. Nationwide distribution in the states of CA, CO, GA, IL, IN, KS, MA, MD,…Official notice →- 2026-03-11
- US
Advanced Bionics, LLC recalls Brand Name: HiResolution Bionic Ear System Product Name: Sky CI M90 Sound Processor Model/Catalog Number: CI-5295-150
Behind-the-ear sound processer packaging label is different then included product.
- 2025-05-28
- US
Advanced Bionics, LLC recalls 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 match the intended product as specified.
Other drugs & medical recalls in the United States
- 2026-05-06
- US
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Medtronic, Inc. recalls Medtronic Sphere-9 Catheter, Model Number AFR-00001; catheter, percutaneous, cardiac ablation, for treatment of atrial flutter.
Ventricular fibrillation (VF) occurred during radiofrequency (RF) therapy with the Medtronic Sphere-9 catheter in patients who have a Biotronik Implantable Cardioverter Defibrillator (ICD) or Biotronik Cardiac…
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North American Rescue LLC. recalls AIDBAGs are first aid kits of convenience composed of individually labeled devices designed as specialty first aid kits designed for…
Kits contain the McKesson TRUE Metrix PRO Professional Monitoring Blood Glucose System that has been recalled for an issue with the software design of the E-5 Error Code where the meter displays an E-5 error code for a…