Advanced 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.
Read the official notice →- Date
- 2026-06-10
- Country
- United States
- Brand
- Advanced Bionics
- Product
- Brand Name: HiResolution" Bionic Ear System Product Name: HiRes Ultra 3D CI HiFocus Mid Scala Model/Catalog Number: CI-1601-04 Software…
- Classification
- Class II
- Units
- U.S. Nationwide distribution in the states of CA, CO, GA, IL, IN, KS, MA, MD,…
- 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 Details may be shortened or out of date; the official notice is the authoritative source.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
- 2026-05-06
USAdvanced 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.
FDA · DeviceAdvanced Bionics, LLCWorldwide - U.S Nationwide distribution including in the state of AK, AL, AR,…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
- 2026-06-10
- US
Kico Knee Innovation Company recalls Arvis Hip & Knee 2.0 Instrument Set, REF: IN-21200 containing one of the following components: IN-10500, Impactor V-Block Assembly;…
The Impactor V-Block Assembly and Trackers A, B, C and E may exhibit signs of early wear and/or corrosion on the exposed magnet face.
FDA · DeviceKico Knee Innovation CompanyWorldwide - US Nationwide distribution in the states of MS, CA, IA, IN, MI,…Official notice → - US
Kico Knee Innovation Company recalls Arvis Hip & Knee 3.0 Instrument Set, REF: IN-28000 containing one of the following components: IN-10500, Impactor V-Block Assembly;…
The V-Block Assembly and Trackers A, B, C and E may exhibit signs of early wear and/or corrosion on the exposed magnet face.
FDA · DeviceKico Knee Innovation CompanyWorldwide - US Nationwide distribution in the states of MS, CA, IA, IN, MI,…Official notice → - US
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. recalls Philips Azurion 3M15, Model Numbers: 722064, 722222 with Software release R2.2.0, R2.2.1, R2.2.3, R2.2.5 and R2.2.6 with…
During the device phase of Roadmap Pro, a user may experience a dark image that is not clinically usable. The dark image may result after the user performs a pedal tap (shortly touching the footswitch pedal without…
- US
Stryker Corporation recalls Neptune Smart Docking Station (120V), Catalog Number 0770-100-000, part of the Neptune Waste Management System
It has been identified that the impacted docking station (SN 2521008873) was not product released from manufacturing and may not have completed required testing prior to being shipped to your facility. There is a…
- US
Covidien, LP recalls Covidien EndoStitch" Polysorb Single Use Loading Unit; Product numbers: 170053 and 170071;
The presence of holes in the pouch may compromise the package s ability to maintain the sterile barrier and protect the product from environmental exposure.
FDA · DeviceCovidien, LPDomestic: Nationwide distribution; International: Austria, Canada, Denmark,…Official notice → - US
GE Medical Systems Information Technologies Inc recalls CASE v7.0 Cardiac Testing System Model no. 3031234-001 Product Code SU3
Electrical sparking may occur at the printer head. If the Electrostatic Discharge (ESD) printer brush becomes dislodged, electrical sparking at the printer head can result in charring or discoloration of thermal…
FDA · DeviceGE Medical Systems Information Technologies IncWorldwide distribution - US Nationwide and the countries of Algeria,…Official notice →