--- title: "Advanced Bionics, LLC Recalls: Agency-Reported Status and History (Oct 1, 2026) | Is It on Recall" description: "Search Advanced Bionics, LLC recall records, lots, firms and dates. Reported status can be incomplete; use the linked agency notice for current instructions." url: https://isitonrecall.com/brand/advanced-bionics-llc/ updated: 2026-10-01 site: "Is It on Recall" language: en --- [Home](https://isitonrecall.com/) / Brand archive # Advanced Bionics, LLC recall records **4** reported ongoing 4 records in this archive. Latest source date Apr 30, 2026. FDA enforcement status can lag behind the recall lifecycle. An empty search or a reported termination is not a personal product-safety determination. Archive changed Oct 1, 2026. USDA FSIS records are unavailable; [check FSIS directly](https://www.fsis.usda.gov/recalls). [Source coverage and dates](https://isitonrecall.com/sources/). ## Records and reported status Apr 30, 2026 FDA device enforcement ### [Brand Name: HiResolution" Bionic Ear System Product Name: HiRes Ultra 3D CI HiFocus Mid Scala Model/Catalog Number: CI-1601-04 Software Version: N/A Product Description: The HiR...](https://isitonrecall.com/recall/fda-device-z-2283-2026-brand-name-hiresolution-bionic-ear-system-product-name-hires-ultra-3d-ci-hifocus-mid-scala-model-cat/) Due to incorrect shelf-life expiration date. Class II Reported ongoing Distribution: U.S. Nationwide distribution in the states of CA, CO, GA, IL, IN, KS, MA, MD, MI, MO, MT, NC, TN, WA and WI. [Official source for Brand Name: HiResolution" Bionic Ear System Product Name: HiRes Ultra 3D CI HiFocus Mid Scala Mod...](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-2283-2026%22) Mar 23, 2026 FDA device enforcement ### [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...](https://isitonrecall.com/recall/fda-device-z-1950-2026-brand-name-hiresolution-bionic-ear-system-product-name-m-zn-air-battery-pak-model-catalog-number-ci/) 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. Class II Reported ongoing Distribution: Worldwide - U.S Nationwide distribution including in the state of AK, AL, AR, AZ, CA, CO, CT, CD, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC,... [Official source for Brand Name: HiResolution" Bionic Ear System Product Name: M Zn-Air Battery Pak Model/Catalog Numb...](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-1950-2026%22) Nov 27, 2025 FDA device enforcement ### [Brand Name: HiResolution Bionic Ear System Product Name: Sky CI M90 Sound Processor Model/Catalog Number: CI-5295-150](https://isitonrecall.com/recall/fda-device-z-1493-2026-brand-name-hiresolution-bionic-ear-system-product-name-sky-ci-m90-sound-processor-model-catalog-numb/) Behind-the-ear sound processer packaging label is different then included product. Class II Reported ongoing Distribution: Unknown [Official source for Brand Name: HiResolution Bionic Ear System Product Name: Sky CI M90 Sound Processor Model/Catalog...](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-1493-2026%22) Mar 5, 2025 FDA device enforcement ### [HiResolution" Bionic Ear System - M Battery Charger Model Number CI-5607](https://isitonrecall.com/recall/fda-device-z-1813-2025-hiresolution-bionic-ear-system-m-battery-charger-model-number-ci-5607/) Due to incorrect the battery charger being packaged and distributed. Product labeling does not match the intended product as specified. Class II Reported ongoing Distribution: U.S.: AZ, FL, MI, SC, TN and TX. O.U.S.: N/A [Official source for HiResolution" Bionic Ear System - M Battery Charger Model Number CI-5607](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-1813-2025%22) ## Reasons in these listed records - Due to incorrect shelf-life expiration date. - 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. - Behind-the-ear sound processer packaging label is different then included product. - Due to incorrect the battery charger being packaged and distributed. Product labeling does not match the intended product as specified. These examples come from this result page and are not a ranking of every recall reason. ## Checking Advanced Bionics, LLC ### Is there a recall on advanced bionics, llc right now? This archive contains 4 records, including 4 with agency-reported ongoing status. The status field can be incomplete or stale. Open the current official notice and match your exact product. ### How do I check my package or product? Compare the product, firm and lot, date, model or serial identifiers with the notice. [Use the label-check guide](https://isitonrecall.com/guides/read-lot-codes/) if you need help locating an identifier. ### Does a matching name mean every item is included? A name is a search match. The agency notice sets the affected products and identifiers. Do not assume that every item with the same name or brand belongs to the recall. ### What if the search finds no matching record? This search has source and keyword limits. Missing records or a missing lot code do not establish that a product is unaffected. [Check source coverage](https://isitonrecall.com/sources/) and the agency's current notices. ### Where can I find older records? Use [monthly archives](https://isitonrecall.com/archives/) or the local search. The initial import covers records dated from October 2021 where available; each source's actual first and latest dates appear on the coverage page. ## Keep checking [Search Advanced Bionics, LLC](https://isitonrecall.com/check/?q=Advanced%20Bionics%2C%20LLC) [Browse related products](https://isitonrecall.com/products/) [Review source dates](https://isitonrecall.com/sources/)