Lower riskMedical device recall · FDA · Published March 5, 2025
Advanced Bionics HiResolution Bionic Ear System M Battery Charger Recall
Advanced Bionics recalls HiResolution Bionic Ear System M Battery Charger Model CI-5607 due to incorrect labeling matching the intended product. Affected units include specific lot numbers.
“Advanced Bionics HiResolution Bionic Ear System M Battery Charger Recall.” GovInfoNow, updated August 18, 2026. https://govinfonow.com/recall/52667-advanced-bionics-hiresolution-bionic-ear-system-m-battery-charger-recall. Based on FDA recall #Z-1813-2025 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1813-2025%22&limit=1).
The FDA announced on March 5, 2025, that Advanced Bionics, LLC is voluntarily recalling the HiResolution Bionic Ear System - M Battery Charger Model Number CI-5607. The hazard stems from incorrect packaging and distribution where product labeling does not match the intended product.
How to tell if you have it
Brand: Advanced Bionics
Product: HiResolution Bionic Ear System - M Battery Charger
Model Number: CI-5607
UDI-DI code: 00840094433977
Lot Numbers: 410488966; 410488967
Quantity: 6 chargers
Sold in U.S. states: AZ, FL, MI, SC, TN and TX
The hazard
The recall is due to the battery charger being incorrectly packaged and distributed. Product labeling does not match the intended product as specified.
Context
GovInfoNow's records show Advanced Bionics, LLC has 8 other recalls on record since February 6, 2019. Recent similar recalls include a HiResolution Bionic Ear System recall for an incorrect shelf-life expiration date (April 30, 2026) and another for packaging label mismatch (November 27, 2025). Other recent recalls of similar products include Omnicell i.v.Station Label Stock Recall (March 25, 2026).
How to tell if you have this one
Check for the model number CI-5607 on the battery charger. Look for lot numbers 410488966 or 410488967 on the packaging or label.
Brand
Advanced Bionics
Category
Medical device
Based on the official FDA remedy
What to do — step by step
Check Product Labeling
Verify the model number and lot numbers on the battery charger to confirm if it is affected.
Where it went and when
Where it was distributed
Distributed in 6 states.
Listed by the agency
Not listed
FDA distribution: “U.S.: AZ, FL, MI, SC, TN and TX. O.U.S.: N/A” States read from FDA’s own wording; “not listed” means the notice does not name it.
States: Arizona, Florida, Michigan, South Carolina, Tennessee, Texas.
Recall timeline
FDA published this recall 3 months after the firm started it.
1Firm started the recall
2FDA classified it Class II
3Published in FDA’s Enforcement Report
Dates from the agency record only; steps without a date are left out.
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
Official source: FDA Recall #Z-1813-2025 (March 5, 2025) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1813-2025 to see it in context.
Plain-language summary written by qwen3:4b on August 18, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.