Recall of Advanced Bionics HiResolution Bionic Ear System Battery Pak

Source: FDA · United States and Worldwide

Areazine synthesizes this FDA recall directly from FDA's official public data feed. See our methodology for full source attribution and refresh cadence.

Advanced Bionics, LLC is recalling 45,173 units of its M Zn-Air Battery Pak due to a non-conforming battery door that fails to meet safety standards.

What this FDA recall tells you, and what most readers miss

This notice was issued by FDA on May 14, 2026 and geographically references United States and Worldwide. Its severity classification of "medium" signals how the issuing agency weighs the risk of harm if no action is taken - "critical" and "high" tier alerts typically carry direct consumer actions, while "medium" and "low" tend toward informational guidance or monitoring advisories. The category it belongs to - FDA Recalls - determines the consumer-protection framework behind it, which shapes what remedies (refunds, replacements, repairs, or the recall itself) are available to affected consumers and which agency holds statutory responsibility for enforcement.

Most readers skim a notice like this, check whether they are personally affected, and move on. The more useful lens is to read it as a data point about the issuing system: how quickly FDA detected the hazard, how precise the geographic or product-identifier scope is, and whether similar notices have clustered in the same category or region in the last 90 days. Cluster patterns frequently precede a broader regulatory action, a single localized FDA recall is isolated; three of them within a quarter often indicate a supply-chain, infrastructure, or seasonal driver that will keep producing notices until something structural changes.

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What Happened

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.

Which Products Are Affected

The affected products are the HiResolution Bionic Ear System's M Zn-Air Battery Pak with model numbers: 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, and CI-5501-280. A total of 45,173 units are affected, with distribution worldwide, including nationwide in the United States (all states) and countries such as Canada, Argentina, Australia, Austria, Belgium, Brazil, Bulgaria, China, Chile, Croatia, Cuba, Czech Republic, Denmark, Egypt, Finland, France, Germany, Greece, Guam, Guatemala, Hong Kong, Hungary, India, Ireland, Israel, Italy, Japan, Kazakhstan, Luxembourg, Malaysia, Netherlands, New Zealand, Norway, Poland, Portugal, Romania, Saudi Arabia, Singapore, Slovenia, South Africa, South Korea, Spain, Sweden, Switzerland, Thailand, Trinidad and Tobago, United Arab Emirates, and United Kingdom. All lots manufactured up to February 3, 2026, are included. The official recall number is Z-1950-2026.

What You Should Do

As this is a voluntary firm-initiated recall, consumers should contact the recalling firm, Advanced Bionics, LLC, for further instructions.

Why This Matters

This recall ensures that the product meets required safety standards, potentially preventing issues related to battery replacement in medical devices.

Source

FDA Recall Notice: Event ID 98678, Recall Number Z-1950-2026.

Original source: FDA Official Notice ↗

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Frequently Asked Questions

Common questions about this FDA recall.

What is this FDA recall about?
Advanced Bionics, LLC is recalling 45,173 units of its M Zn-Air Battery Pak due to a non-conforming battery door that fails to meet safety standards.
Which agency issued this alert?
This alert was issued by FDA. The original notice is available at the source link at the bottom of this article.
How severe is this alert?
This alert is classified as "medium" severity. Stay informed and follow agency guidance.
What area is affected?
This alert affects United States and Worldwide. Check with FDA for the most current geographic scope.
Where can I find more FDA Recalls updates?
Browse the full FDA Recalls feed on Areazine at areazine.com/recalls/fda/ for the latest updates from FDA and other agencies.