Class II U.S. Food and Drug Administration

Advanced Bionics, LLC Brand Name: HiResolution" Bionic Ear System Product Name: M recall: The non-tamperproof battery door supplied with the sound processor fails

Recall published 6 months ago

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.

The hazard: Button battery hazard

Accessible button batteries prompted this notice. The danger is not the size of the cell but the current it still carries after the toy has stopped working.

What the notice says: 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.

Why it matters: The battery compartment can be opened by a child, or the cell can work loose. A swallowed coin-cell battery generates an alkaline burn where it lodges and can damage the oesophagus within a couple of hours — while the child still looks well.

Symptoms and when to call a doctor

A swallowed button battery is an emergency. Go straight to an emergency department; do not induce vomiting and do not give food or drink unless staff tell you to. The National Battery Ingestion Hotline on 800-498-8666 takes calls around the clock. Early signs can be as vague as drooling, refusing food, coughing, gagging or chest pain, and a child who swallowed one unobserved may show nothing at all at first.

This page is general information, not medical advice. If you feel unwell, a clinician who can see you is the only person able to judge your case.

Recall details

Recall number
Z-1950-2026
Published
May 6, 2026
Risk level
Class II
Status
Ongoing
Issued by
U.S. Food and Drug Administration
Brand
Advanced Bionics, LLC
Product type
Medical devices
Units affected
45173
Distribution
Nationwide
Made in
United States
Lot / code info
Lot Code: All lots manufactured up to February 3, 2026. Refer to Exhibit_0006

Products covered by this recall

Brand Name: HiResolution" Bionic Ear System Product Name: M Zn-Air Battery Pak Model/Catalog Number: CI-5501-110; CI-5501-120; CI-5501-130; CI-5501-140; CI-5501-150; CI-5501-190; CI-5501-240; CI-5501-250; CI-5501-260; CI-5501-270; CI-5501-280 Software Version: Not Applicable Product Description: The M Zn-Air Battery Pak is a disposable power source for the Naida" CI M and Sky CI" M Sound Processors. The type of disposable battery to be used with the M Zn-Air Battery Pak is a 675 power implant battery (P675). Regular 675 hearing instrument batteries will not be powerful enough for a cochlear implant. The suggested manufacturer and battery is PowerOne P675 Implant Plus battery. The M Zn-Air Battery Pak is available with non-tamperproof and tamperproof cartridges. Component: Not Applicable

Check your product

The notice names 2 codes you can read straight off the package. Type the one printed on yours and the list below narrows to it.

Lot or batch code

Usually ink-stamped near the seam, the cap or the bottom of the pack.

  • 2026. Refer

Model or item number

On the rating label, the box or the instruction sheet.

  • CI-5501-110

Codes are lifted verbatim from the FDA — Device enforcement notice. A code that is missing here may still be covered — the official notice is the complete list.

What to do about Button battery

Advanced Bionics, LLC — Accessible button batteries prompted this notice. The danger is not the size of the cell but the current it still carries after the toy has stopped working.

  1. Take the product away from children now, before reading the rest of this page.
  2. Follow the company’s remedy for the product itself and keep the packaging until the claim is settled.
  3. If a battery is missing from the product, treat that as a possible ingestion and go to an emergency department.
  4. Do not tape the compartment shut and carry on — the remedy on this page exists because that does not hold.

If the claim stalls

Most recall claims are paid without argument. The ones that stall usually stall for a reason you can fix.

  • Check you used the recall channel rather than ordinary customer support — the two queues rarely talk to each other.
  • If the company is unresponsive or has stopped trading, report it to the CPSC at SaferProducts.gov, and try the retailer in parallel.
  • Paid by card? A chargeback for goods that are unfit for sale is a legitimate fallback once the company has had a fair chance.
  • Send the photos they asked for in the format they asked for. A missing date code is the single commonest reason a claim sits unprocessed.

Company contact: Advanced Bionics, LLC — 28515 Westinghouse Pl, Valencia, CA, 91355-1398

The official notice

This page summarises a notice published by U.S. Food and Drug Administration. The agency notice is the authoritative version — read it before you act, and treat it as the final word if anything here looks different.

Open the FDA — Device enforcement record U.S. Food and Drug Administration recalls

Questions people ask about this recall

Why was Advanced Bionics, LLC medical devices recalled?

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. 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.

How do I know if I have the recalled product?

Match the codes printed on your package against the notice: lot code 2026. Refer; model number CI-5501-110. If the code on your package is not on that list, your unit is outside the recall.

What should I do with it right now?

Take the product away from children now, before reading the rest of this page.

Can I get my money back?

Check you used the recall channel rather than ordinary customer support — the two queues rarely talk to each other.

Where was the recalled product sold?

It was distributed nationwide.

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