Recall of Advanced Bionics HiResolution Bionic Ear System Battery Pak
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 verify its scope, source, and timestamp, then compare related notices without assuming that one record proves a broader trend.
Areazine pairs this record with the original agency URL so you can check the primary source before acting. Its related labels are recall, product-safety, fda, Devices.
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 ↗
Related FDA Recalls
All FDA Recalls →Nationwide notices with similar length or severity timing 8
Two Areazine-derived peer sets for this FDA recall: nearest notices by body length and by same severity near the same agency date. Peers come from other categories so they are not the same-feed Related list above.
Similar body length
Nearest notices by article body length (1,626 characters here).
Similar severity timing
Same severity (medium) notices issued closest in time to May 14, 2026.
Frequently Asked Questions
Common questions about this FDA recall.