Public recall detail

M Zn-Air Battery Pak

2026-05-06

medium
Ear, nose and throat Performance
Quick summary

Quick summary: M Zn-Air Battery Pak. Reason: Performance. Category: Ear, nose and throat. Date: 2026-05-06.

Recommended action

Recommended action: compare your product with the official notice and follow the instructions published by the official source.

Recall details

Quick summary: M Zn-Air Battery Pak. Reason: Performance. Category: Ear, nose and throat. Date: 2026-05-06.

Official details

Affected product details

Structured information extracted from the official recall notice. Confirm the identifiers and instructions in the original notice.

BrandAdvanced Bionics, LLC
ProductM Zn-Air Battery Pak
IssueMedical devices - Performance
Recall classType II
IdentificationRA-82035

Affected products

ProductM Zn-Air Battery Pak
LotAll lots.
ModelCI-5501-150
Serial numberAll lots.
DescriptionM Zn-Air Battery Pak
ProductM Zn-Air Battery Pak
LotAll lots.
ModelCI-5501-260
Serial numberAll lots.
DescriptionM Zn-Air Battery Pak
ProductM Zn-Air Battery Pak
LotAll lots.
ModelCI-5501-280
Serial numberAll lots.
DescriptionM Zn-Air Battery Pak
ProductM Zn-Air Battery Pak
LotAll lots.
ModelCI-5501-110
Serial numberAll lots.
DescriptionM Zn-Air Battery Pak
ProductM Zn-Air Battery Pak
LotAll lots.
ModelCI-5501-190
Serial numberAll lots.
DescriptionM Zn-Air Battery Pak
ProductM Zn-Air Battery Pak
LotAll lots.
ModelCI-5501-250
Serial numberAll lots.
DescriptionM Zn-Air Battery Pak
ProductM Zn-Air Battery Pak
LotAll lots.
ModelCI-5501-120
Serial numberAll lots.
DescriptionM Zn-Air Battery Pak
ProductM Zn-Air Battery Pak
LotAll lots.
ModelCI-5501-240
Serial numberAll lots.
DescriptionM Zn-Air Battery Pak
ProductM Zn-Air Battery Pak
LotAll lots.
ModelCI-5501-270
Serial numberAll lots.
DescriptionM Zn-Air Battery Pak
ProductM Zn-Air Battery Pak
LotAll lots.
ModelCI-5501-130
Serial numberAll lots.
DescriptionM Zn-Air Battery Pak
ProductM Zn-Air Battery Pak
LotAll lots.
ModelCI-5501-140
Serial numberAll lots.
DescriptionM Zn-Air Battery Pak

Issue

The non‑tamperproof battery door in the M Zn‑Air Battery Pak (CI‑5501) does not meet IEC 60601‑1‑11:2015 clause 8.5.2 because it allows battery access without a tool, creating potential safety risk. No injuries are reported, but the recall instructs customers to dispose of the affected door per local guidelines.

What you should do

  • Follow manufacturer's instructions on removing non-tamperproof battery door and dispose of it. Ask for replacements with tamperproof battery doors.
Additional official information
AudienceGeneral public
CategoryHealth products - Medical devices - Ear, nose and throat
CompaniesAdvanced Bionics, LLC 28515 Westinghouse Place, Valencia, California, United States, 91355
Recall date2026-03-25
Published byHealth Canada
Recall classType II
Alert / recall typeHealth product recall
Identification numberRA-82035
Background{}
CompaniesAdvanced Bionics, LLC 28515 Westinghouse Place, Valencia, California, United States, 91355
AudiencesGeneral public
Source updated2026-05-06

Contains information licensed under the Open Government Licence – Canada. SafetyPulse is independent of the Government of Canada.

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