Health Canada · October 8, 2026
- Affected product
- FreeO2 Automated Oxygen Therapy Device Adult & Pediatric - Version
- Category
- Medical device recalls
- Hazard
- Under specific conditions following a deep battery discharge, error 29515 may occur during startup of a FreeO2 HW 2.3 device using software package 1.4.2 and prevent its use. The update to software package 1.4.3 corrects this issue and restores the expected…
Check affected FreeO2 Automated Oxygen Therapy Device Adult & Pediatric - Version identifiers →Health Canada · October 8, 2026
- Affected product
- TruSystem 7000 and TruSystem 7500 Surgical Tables
- Category
- Medical device recalls
- Hazard
- Baxter Corporation is issuing a voluntary correction for certain TruSystem 7000 and TruSystem 7500 surgical tables due to a reported issue with the main lift mechanism. The issue has been associated with unexpected wear of the main lift assembly, also known as…
Check affected TruSystem 7000 and TruSystem 7500 Surgical Tables identifiers →Health Canada · October 8, 2026
- Affected product
- Cardinal Health Presource Kits
- Category
- Medical device recalls
- Hazard
- Cardinal Health Presource® has identified various kits that may contain a component impacted by the welmed, extension tubing sets component. that advisory was issued to inform customers of a product condition identified in certain lots and to provide…
Check affected Cardinal Health Presource Kits identifiers →Health Canada · October 6, 2026
- Affected product
- Cardinal Health General Procedure Tray
- Category
- Medical device recalls
- Hazard
- Cardinal Health was recently informed of a medical device recall from Becton Dickinson concerning the BD Alaris™ Pump Infusion sets used with BD Alaris™ pump module model 8100 referenced.Tthe recall is being issued due to BD requesting the discontinuation of…
Check affected Cardinal Health General Procedure Tray identifiers →Health Canada · October 6, 2026
- Affected product
- Medline Bariatric Rollator
- Category
- Medical device recalls
- Hazard
- Specific lots of Medline BariatricRollator (SKU: MDS86800XWS), are being recalled due to the front fork stem bolt/wheel assembly disconnecting from the rollator frame tubing. The immediate consequences could include falls resulting in head trauma, bone…
Check affected Medline Bariatric Rollator identifiers →Health Canada · October 6, 2026
- Affected product
- Embletta MPR PG
- Category
- Medical device recalls
- Hazard
- of incorrect patient information being associated with a study, loss of diagnostic data, delays in diagnosis, or the need to repeat patient testing. Additional information Details Original
Check affected Embletta MPR PG identifiers →Health Canada · October 6, 2026
- Affected product
- FreeO2 Automated Oxygen Therapy Device Adult & Pediatric
- Category
- Medical device recalls
- Hazard
- A battery reading error may occur when certain Freeo2 HW 1.2 devices are restarted following an upgrade from software version 1.2.X to 1.4.X. The error is immediately detectable, prevents the device from being returned to service and requires installation of a…
Check affected FreeO2 Automated Oxygen Therapy Device Adult & Pediatric identifiers →Health Canada · October 5, 2026
- Affected product
- hCG One Step Pregnancy Tests
- Category
- Medical device recalls
- Hazard
- Product may detect low levels of HCG below the stated assay sensitivity which may result in false positive test results in samples from non-pregnant individuals. The package insert is being updated to note that low HCG levels can occur at or after onset of…
Check affected hCG One Step Pregnancy Tests identifiers →Health Canada · October 2, 2026
- Affected product
- hCG Cassettes
- Category
- Medical device recalls
- Hazard
- Product may detect low levels of HCG below the stated assay sensitivity which may result in false positive test results in samples from non-pregnant individuals. The package insert is being updated to note that low HCG levels can occur at or after onset of…
Check affected hCG Cassettes identifiers →Health Canada · October 1, 2026
- Affected product
- Radiography 7000 M
- Category
- Medical device recalls
- Hazard
- Philips has become aware of a potential safety issue impacting the Radiography 7000 M system (Model 712010) where the drive function may fail immediately after an exposure, causing the system to remain stationary. The issue may occur with the Radiography 7000…
Check affected Radiography 7000 M identifiers →Health Canada · October 1, 2026
- Affected product
- Direxion and Direxion HI-FLO Microcatheters
- Category
- Medical device recalls
- Hazard
- Boston scientific is initiating the removal of specific lots of Direxion and Direxion HI-FLO Microcatheters due to a manufacturing issue that may cause difficulty withdrawing the device from the carrier hoop and difficulty advancing or withdrawing the device…
Check affected Direxion and Direxion HI-FLO Microcatheters identifiers →Health Canada · October 1, 2026
- Affected product
- CareIntellect Perinatal
- Category
- Medical device recalls
- Hazard
- GE Healthcare has become aware of an issue in CareIntellect Perinatal (CIP) that may result in loss of monitoring information and clearance of active patient monitoring alarms. When this issue occurs due to an interruption in system connectivity, monitoring…
Check affected CareIntellect Perinatal identifiers →Health Canada · October 1, 2026
- Affected product
- Medline Convenience Kits Containing Cannula Components with Female
- Category
- Medical device recalls
- Hazard
- Specific item(s) and lot(s) of Medline Convenience Kits Containing Cannula Components with Female Luer Lock Connectors are being recalled. Medline has identified that the components do not conform to ISO 80369-7 dimensional requirements. The nonconforming…
Check affected Medline Convenience Kits Containing Cannula Components with Female identifiers →Health Canada · September 28, 2026
- Affected product
- BD Alaris™ Pump Module and subset of Compatible Pump Infusion Sets
- Category
- Medical device recalls
- Hazard
- BD is initiating this voluntary recall notice to inform customers of worse performance, under certain use cases, for the BD Alaris™ Pump Module model 8100 (pump module) when used with a subset of compatible pump infusion sets (see Appendix A). Pump infusion…
Check affected BD Alaris™ Pump Module and subset of Compatible Pump Infusion Sets identifiers →Health Canada · September 24, 2026
- Affected product
- Inzone® Detachment System
- Category
- Medical device recalls
- Hazard
- Stryker has observed that some devices may experience premature battery drain. When this occurs, the devices may: not power on; power on with faint audible and visual indicators; be unable to detach a coil as intended.
Check affected Inzone® Detachment System identifiers →Health Canada · September 23, 2026
- Affected product
- Williams Cystoscopic Injection Needle
- Category
- Medical device recalls
- Hazard
- Cook Medical identified that products supplied in the affected device lots may have been manufactured out of specification. Specifically, the female luer lock adapter component may not have been correctly seated due to misalignment and inadequate torquing…
Check affected Williams Cystoscopic Injection Needle identifiers →Health Canada · September 18, 2026
- Affected product
- SIGNA™ Artist and SIGNA™ Artist Evo
- Category
- Medical device recalls
- Hazard
- GE Healthcare has become aware of an exposed sharp edge inside the SIGNA™ Artist Evo and SIGNA™ Artist electronics cabinet that could damage power cables, which may potentially cause an electrical fault. If the electrical fault is present and the cabinet door…
Check affected SIGNA™ Artist and SIGNA™ Artist Evo identifiers →Health Canada · September 18, 2026
- Affected product
- Counterfeit laser hair removal and therapy devices found in some
- Category
- Medical device recalls
- Hazard
- s Last updated 2026-09-18 Summary Product Soprano diode laser hair removal systems and diode laser therapy systems Issue Medical devices Health products - Product safety Health products - Unauthorized product What to do Do not buy or use unauthorized medical…
Check affected Counterfeit laser hair removal and therapy devices found in some identifiers →Health Canada · September 10, 2026
- Affected product
- IMN Screws System Advanced Locking Screw
- Category
- Medical device recalls
- Hazard
- Following a product complaint, and as part of its standard quality process, Stryker confirmed that one lot of T2 Alpha IMN advanced locking is incorrectly labeled. The product contains a 75mm length screw instead of 57.5mm.
Check affected IMN Screws System Advanced Locking Screw identifiers →Health Canada · September 10, 2026
- Affected product
- Centricity High Acuity Anesthesia
- Category
- Medical device recalls
- Hazard
- GE Healthcare has become aware of two potential issues associated with certain Centricity High Acuity (CHA) systems. Safety issue #1, involving the order and recording summary component used in displays and printed reports within CHA applications. Safety issue…
Check affected Centricity High Acuity Anesthesia identifiers →Health Canada · September 9, 2026
- Affected product
- Philips Ingenia, Achieva and Intera MR Systems
- Category
- Medical device recalls
- Hazard
- Philips has become aware of a software issue affecting Philips Magnetic Resonance (MR) imaging systems operating with software versions R5 & R11, which may terminate an examination during the image reconstruction process. If the scan parameters are manually…
Check affected Philips Ingenia, Achieva and Intera MR Systems identifiers →Health Canada · September 9, 2026
- Affected product
- Veradius Unity and BV Pulsera Mobile C-Arm System-9in. and 12in
- Category
- Medical device recalls
- Hazard
- Air bubbles may develop in the monoblock oil when there is a prolonged period between manufacture and installation, for example due to storage, transportation, or other pre-installation holding time. During a clinical procedure, when the user activates X-ray…
Check affected Veradius Unity and BV Pulsera Mobile C-Arm System-9in. and 12in identifiers →Health Canada · September 4, 2026
- Affected product
- Imager™ II Angiographic Catheter
- Category
- Medical device recalls
- Hazard
- of tip degradation and detachment. Additional information Details Original
Check affected Imager™ II Angiographic Catheter identifiers →Health Canada · September 4, 2026
- Affected product
- Imager™ II Angiographic Catheter
- Category
- Medical device recalls
- Hazard
- of tip degradation and detachment. Additional information Details Original
Check affected Imager™ II Angiographic Catheter identifiers →Health Canada · September 4, 2026
- Affected product
- LIFEPAK ® 35 Monitor/Defibrillator
- Category
- Medical device recalls
- Hazard
- During production of LP35, Stryker identified that certain printer and modem access port connectors may not have been fully seated within the rear housing assembly. As a result, the connectors may appear flush with or recessed relative to the retaining nut…
Check affected LIFEPAK ® 35 Monitor/Defibrillator identifiers →Health Canada · September 2, 2026
- Affected product
- BiCOAG Hemostasis Probe
- Category
- Medical device recalls
- Hazard
- Olympus determined that the affected products may have been manufactured without the designated amount of adhesive to the rear of the device’s ceramic tip, which may result in detachment of the ceramic tip. Customers should immediately discontinue using the…
Check affected BiCOAG Hemostasis Probe identifiers →Health Canada · September 2, 2026
- Affected product
- LEO+ Intracranial Self Expandable Stent And Delivery System
- Category
- Medical device recalls
- Hazard
- As a precautionary measure, Balt Extrusion is voluntarily recalling specific ANRYV connector lots after routine quality control identified non-conforming bacterial endotoxin test results. The recall affects both standalone ANRYV connectors and ANRYV connectors…
Check affected LEO+ Intracranial Self Expandable Stent And Delivery System identifiers →Health Canada · September 2, 2026
- Affected product
- Quantum PureFlow Standard Heat Exchanger High Flow
- Category
- Medical device recalls
- Hazard
- Blood-to-glycol leakage was identified in the heat exchanger during the procedure. Glycol compartment contamination may result in blood contamination of the heater-cooler due to glycol circulation for thermoregulation. Customer communication is considered…
Check affected Quantum PureFlow Standard Heat Exchanger High Flow identifiers →Health Canada · August 28, 2026
- Affected product
- Carestation 850
- Category
- Medical device recalls
- Hazard
- Unexpected shutdown of Carestation 850 and 850C anesthesia systems when AC mains power is disconnected or AC mains power is lost.
Check affected Carestation 850 identifiers →Health Canada · August 27, 2026
- Affected product
- Automated Impella Controller (AIC)
- Category
- Medical device recalls
- Hazard
- based strategy for component replacement will be implemented. The purge flag is the component that engages with the purge disc and allows the AIC to recognize the purge disc. These AIC purge flag component failures may result most frequently in user…
Check affected Automated Impella Controller (AIC) identifiers →Health Canada · August 27, 2026
- Affected product
- Cardinal Health Gynaecology Robotics and Endoscopy Packs
- Category
- Medical device recalls
- Hazard
- Cardinal Health was recently informed of a medical device recall from Stryker concerning the StrykeFlow PS referenced. the recall is being issued due to an increased amount in reported complaints consistently describing leaking from the handpiece during use.
Check affected Cardinal Health Gynaecology Robotics and Endoscopy Packs identifiers →Health Canada · August 26, 2026
- Affected product
- Cyanosure DermaV Laser System
- Category
- Medical device recalls
- Hazard
- Cynosure Lutronic has identified a adverse trend of complaint reports in North America for spark and loud noise resulting in patient burns during vascular treatment with the DermaV laser system. There is a remote possibility that utilizing higher fluences at…
Check affected Cyanosure DermaV Laser System identifiers →Health Canada · August 25, 2026
- Affected product
- Dräger VentStar® Resus Neo and VentStar® Resuscitaire
- Category
- Medical device recalls
- Hazard
- The manufacturer has became aware of cases in which obvious cracks in the hose of the VentStar® Resus Neo and VentStar® Resuscitaire were detected by the users prior to use. In no case draeger was informed of any negative effects on the health of the affected…
Check affected Dräger VentStar® Resus Neo and VentStar® Resuscitaire identifiers →Health Canada · August 21, 2026
- Affected product
- iQ200 Series Analyzers and DxU 840m/850m Iris Analyzers
- Category
- Medical device recalls
- Hazard
- Additional information Details Original
Check affected iQ200 Series Analyzers and DxU 840m/850m Iris Analyzers identifiers →Health Canada · August 20, 2026
- Affected product
- Patient Information Centre iX
- Category
- Medical device recalls
- Hazard
- ous situation occurs if the observed behavior is: Loss of central alarming, Loss of, or frozen, waveforms/data display -Bedside monitors and telemetry devices could generate a "No Central Mon" INOP Additional information Details Original
Check affected Patient Information Centre iX identifiers →Health Canada · August 20, 2026
- Affected product
- IMRIS Table ORT 300
- Category
- Medical device recalls
- Hazard
- associated with the ORT300 Operating Room Tables. As part of this action, corrective measures will be implemented to replace the linear actuator and rotation lock mechanism components on affected tables with an updated design. Additional information Details…
Check affected IMRIS Table ORT 300 identifiers →Health Canada · August 20, 2026
- Affected product
- Centricity™ Enterprise Archive and PACS Workstation
- Category
- Medical device recalls
- Hazard
- GE Healthcare has become aware that, under certain conditions, historical imaging data migrated from a legacy system may become incorrectly associated with a different patient. If this occurs, studies or images may be displayed under the wrong patient record,…
Check affected Centricity™ Enterprise Archive and PACS Workstation identifiers →Health Canada · August 19, 2026
- Affected product
- Embosphere® Microspheres-Syringe
- Category
- Medical device recalls
- Hazard
- (s), use of the
Check affected Embosphere® Microspheres-Syringe identifiers →Health Canada · August 19, 2026
- Affected product
- StatStrip® Glucose And Beta-Ketone Hospital Meter
- Category
- Medical device recalls
- Hazard
- A software issue in StatStrip (Gen 2) Glucose and Beta-Ketone Hospital Meters may retain previous patient information during barcode scanning, potentially assigning results to the wrong patient. Users should verify patient identification before accepting…
Check affected StatStrip® Glucose And Beta-Ketone Hospital Meter identifiers →Health Canada · August 17, 2026
- Affected product
- Cook Medical Hemospray Kit
- Category
- Medical device recalls
- Hazard
- of potential endoscope adherence and inability to spray powder. Additional information Details Original
Check affected Cook Medical Hemospray Kit identifiers →
