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 →Health Canada · August 14, 2026
- Affected product
- Orthopaedic Implant Components
- Category
- Medical device recalls
- Hazard
- Stryker has become aware that the devices listed in the Customer Letter were manufactured with Ultra High Molecular Weight Polyethylene (UHMWPE) raw material aged in excess of five (5) years. Industry guidance for storage duration of UHMWPE raw material used…
Check affected Orthopaedic Implant Components identifiers →Health Canada · August 14, 2026
- Affected product
- Endotracheal Tube, Cuffed
- Category
- Medical device recalls
- Hazard
- The 6FR suction catheter could not pass smoothly through the 2.5mm sizes of cuffed tracheal tube. This may lead to reintubations if the airway is unable to be suctioned.To date, there have been two complaints reported from united states customers where one…
Check affected Endotracheal Tube, Cuffed identifiers →Health Canada · August 11, 2026
- Affected product
- Omni-Tract Surgical Retractor System
- Category
- Medical device recalls
- Hazard
- Integra Lifesciences is issuing a correction to the Integra® Omni-Tract® Surgical Retractor System - existing Instructions For Use (IFU) related to prevacuum sterilization dry time requirements, to ensure the Omni-Tract® devices and components are properly…
Check affected Omni-Tract Surgical Retractor System identifiers →Health Canada · August 7, 2026
- Affected product
- Bravo - Capsule Delivery System
- Category
- Medical device recalls
- Hazard
- s associated with this issue include patient aspiration/inhalation, perforation of esophagus, obstruction of the airway, hemorrhage/blood loss/bleeding, laceration of the esophagus, a delay in diagnosis, and foreign bodies remaining in the patient. Lots with…
Check affected Bravo - Capsule Delivery System identifiers →Health Canada · August 6, 2026
- Affected product
- Beckman Coulter AU Immunochemistry System - AU480 Analyzer
- Category
- Medical device recalls
- Hazard
- Beckman Coulter has determined that a software defect in AU480 chemistry analyzers using Microsoft® SQL server 2022 express may cause a DB connection error that renders alarmDB unreadable and prevents instrument startup. The issue is associated with…
Check affected Beckman Coulter AU Immunochemistry System - AU480 Analyzer identifiers →Health Canada · August 6, 2026
- Affected product
- HEALON EndoCoat PRO
- Category
- Medical device recalls
- Hazard
- s associated with cannula insertion and provide additional clarification regarding insertion technique to support the safe and effective use of the product. This recall does not require removal or return of the product from the market. When used in accordance…
Check affected HEALON EndoCoat PRO identifiers →