CLASS II ONGOING Device recall · Reported 28 May 2025 · FDA Enforcement Report

HiResolution" Bionic Ear System - M Battery Charger recalled

Advanced Bionics is recalling HiResolution" Bionic Ear System - M Battery Charger, distributed in Arizona, Florida, Michigan, South Carolina, Tennessee, Texas. The recall was initiated on 5 Mar 2025 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesM Battery Charger Model Number: CI-5607 UDI-DI code: 00840094433977 Lot Numbers: 410488966; 410488967

Quantity recalled6 chargers

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-1813-2025
FDA event ID: 96668
Recalling firm: Advanced Bionics, Valencia, CA
Classification: Class II
Status: Ongoing
Recall initiated: 5 Mar 2025
FDA classified: 22 May 2025
Reported: 28 May 2025
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Packaging Defects
Device type: Other Medical Devices

Timeline

5 Mar 2025	Recall initiated by company
22 May 2025	Classified by FDA	+78 days
28 May 2025	Published in enforcement report	+6 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

Due to incorrect the battery charger being packaged and distributed. Product labeling does not match the intended product as specified.

Packaging recalls include wrong labels, wrong products in the wrong bottle, missing leaflets, short-filled or empty capsules and seals that fail.

Product as listed by the FDA

HiResolution" Bionic Ear System - M Battery Charger Model Number CI-5607

Where it was distributed

U.S.: AZ, FL, MI, SC, TN and TX. O.U.S.: N/A

Arizona Florida Michigan South Carolina Tennessee Texas

Questions about this recall

Why was it recalled?

Due to incorrect the battery charger being packaged and distributed. Product labeling does not match the intended product as specified.

Which lots are affected?

M Battery Charger Model Number: CI-5607 UDI-DI code: 00840094433977 Lot Numbers: 410488966; 410488967

Where was it sold?

U.S.: AZ, FL, MI, SC, TN and TX. O.U.S.: N/A

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

More recalls from Advanced Bionics

All 14

Reported	Class	Recall	Company	Reason	Where
10 Jun 2026Device	CLASS II	HiResolution" Bionic Ear System HiRes Ultra 3D CI HiFocus Mid Scala recalled	Advanced Bionics	Device Malfunction	Nationwide
6 May 2026Device	CLASS II	HiResolution" Bionic Ear System M Zn-Air Battery Pak recalled	Advanced Bionics	Device Malfunction	Nationwide
11 Mar 2026Device	CLASS II	HiResolution Bionic Ear System Sky CI M90 Sound Processor recalled	Advanced Bionics	Packaging Defects	CA
2 Dec 2020Device	CLASS III	AB PowerCel 230 (velvet black) recalled by Advanced Bionics	Advanced Bionics	Labeling Errors	Nationwide
2 Dec 2020Device	CLASS III	AB PowerCel 170 (velvet black) recalled by Advanced Bionics	Advanced Bionics	Labeling Errors	Nationwide

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