FDAMarch 23, 2026device
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: ...
Official recall recorded by the U.S. Food & Drug Administration.
The hazard
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.
What to do
FDA enforcement status: Ongoing
Brands named
advanced bionicsadvanced
Recall history
Other federal recalls tied to the same brand — a factual pattern, straight from the source data.
- CPSCHonlyne LED Party Favors Recalled Due to Risk of Serious Injury Death from Battery Ingestion; Violate Mandatory Standard for Consumer Products with Button Cell Batteries; Sold by Huizhou Rongheng Network Technology2026-06-25
- FDABrand 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 HiResolution Bionic Ear System is a cochlear implant designed to provide useful hearing to individuals with severe-to-profo...2026-04-30
- FDAiLet Bionic Pancreas, REF: BB10012026-03-12
- FDABrand Name: HiResolution Bionic Ear System Product Name: Sky CI M90 Sound Processor Model/Catalog Number: CI-5295-1502025-11-27
- FDATESTO-100 CIII (testosterone 100 mg), 10 Sterile Pellets per carton, Rx only, Manufactured by: Advanced Pharmaceutical Technology, 132 South Central Avenue, Elmsford, NY 10523, NDC# 57377-100-012025-10-03
- FDAiLet Bionic Pancreas, REF: BB10012025-09-23
- FDATribio Implant 7.5mm x 40mm REF M80 SB008 UDI code: (01) 00816125023653(10) EBL10B13C(17) 270630 Tribio" Implant is indicated for use in bony voids or gaps of the skeletal system (i.e. extremities, pelvis and posterolateral spine). These osseous defects are surgically created or result from traum...2025-09-02
- FDAiLet Ace Pump Kit REF: BB1001 iLet Dosing Decision Software2025-08-13
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