Public recall detail

Volara System Patient Ciruit

2026-05-29

medium
Health products Health product recall
Quick summary

Quick summary: Volara System Patient Ciruit. Reason: Health product recall. Category: Health products. Date: 2026-05-29.

Recommended action

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

Recall details

Quick summary: Volara System Patient Ciruit. Reason: Health product recall. Category: Health products. Date: 2026-05-29.

Official details

Affected product details

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

BrandHill-Rom Services Private Limited
ProductVolara System Patient Ciruit
IssueMedical devices - Performance
Recall classType II
IdentificationRA-82135

Affected products

ProductVolara P.Circuit Kit
LotAll lots.
ModelM08473
Serial numberAll lots.
DescriptionVolara P.Circuit Kit
ProductVolara P.Circuit Kit
LotAll lots.
ModelM08085
Serial numberAll lots.
DescriptionVolara P.Circuit Kit
ProductVolara P.Circuit Kit
LotAll lots.
ModelM08474
Serial numberAll lots.
DescriptionVolara P.Circuit Kit
ProductVolara System
LotAll lots.
ModelPVL1ACCA
Serial numberAll lots.
DescriptionVolara System
ProductVolara System
LotAll lots.
ModelPVL1HCCA
Serial numberAll lots.
DescriptionVolara System

Issue

Baxter Corporation is issuing an urgent medical device correction for Volara System patient circuits due to reports of air and medication leakage from the nebulizer cup during therapy. The leakage can lead to patient desaturation and ineffective nebulization, impacting the delivery of prescribed therapy.

What you should do

  • Contact the manufacturer if you require additional information.
Additional official information
AudienceGeneral public Healthcare
CategoryHealth products - Medical devices - Anaesthesiology
CompaniesHill-Rom Services Private Limited 1 Yishun Avenue 7, Singapore, Singapore, 768923
Recall date2026-05-21
Published byHealth Canada
Recall classType II
Alert / recall typeHealth product recall
Identification numberRA-82135
Background{}
CompaniesHill-Rom Services Private Limited 1 Yishun Avenue 7, Singapore, Singapore, 768923
AudiencesGeneral public Healthcare
Source updated2026-05-29

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

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