Recall of Advanced Bionics HiResolution Bionic Ear System Battery Pak
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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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