FDAMarch 5, 2025device

HiResolution" Bionic Ear System - M Battery Charger Model Number CI-5607

Official recall recorded by the U.S. Food & Drug Administration.

The hazard

Due to incorrect the battery charger being packaged and distributed. Product labeling does not match the intended product as specified.

What to do

FDA enforcement status: Ongoing

Brands named

advanced bionicsadvanced

UPCs

00840094433977

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
FDABrand 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: ...2026-03-23
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

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