Health Canada Recalls & Safety Alerts

Philips Ingenia and Achieva MRI Systems - MRE Liver Stiffness Measurement Recall

Health Canada has issued a Type I recall for Philips Ingenia and Achieva MRI Systems following identification of two software issues affecting diagnostic accuracy. The primary issue involves MRE (Magnetic Resonance Elastography) stiffness measurements where default scan protocol voxel size settings are too small, potentially producing inaccurate (lower) liver stiffness values. A secondary issue affects Philips Vue Motion v12.2.0-v12.2.8.500 where mis-ordered image frames during dynamic cine runs may display out of sequence. Affected products include multiple Ingenia and Achieva 3.0T models with specific lot numbers.

i-STAT EG7+ Cartridge Recall for pH Errors

Health Canada has issued a Type II recall for Abbott Point of Care Inc.'s i-STAT EG7+ Cartridge due to a manufacturing defect causing inaccurate pH and pCO2 readings. Affected lots (N25209, Model 03P76-25) may report higher than expected pCO2 and lower than expected pH results, potentially leading to inappropriate clinical interventions. Healthcare providers should immediately discontinue use of these cartridges for pH and pCO2 testing and contact the manufacturer for additional information.

Nitrous Oxide Chargers: Sold for Inhalation Without Market Authorization (DIN) - Type I Recall

Health Canada has issued a Type I recall (RA-81896) for nitrous oxide (N2O) chargers sold by DOODLEZ, Gold Whip, and Whip-it! brands, all marketed for inhalation without market authorization (DIN). The recall affects flavored and unflavored gas chargers distributed by Mega Sphere Trading (Calgary, AB). Health Canada warns consumers not to inhale nitrous oxide products for recreational purposes due to serious health risks.

Medtronic SynchroMed Programmer Application Software Recall, Type II

Health Canada has issued a Type II recall for Medtronic's SynchroMed Clinician Programmer Application (CP app) model A810 due to a software sequencing issue affecting flex dosing programming for SynchroMed 8637 and 8667 infusion pumps. When flex dosing steps are added overlapping and out of chronological order, the app may fail to reorder them correctly, potentially causing infusion steps to be delivered at incorrect times, leading to missed doses, underdosing, or shifted dose timing without immediate alerts. Eleven complaints have been reported globally. Affected parties should contact Medtronic for information and guidance.

Bard and Daig Steerable Diagnostic EP Catheter Recall for Sterility Breach

Health Canada issued a Type II recall for Bard Dynamic Deca Steerable Diagnostic EP Catheters (model 201101) and Daig Livewire Steerable Diagnostic EP Catheters (models 401904, 401575) due to breached sterile barriers on the chevron seal side of the primary Tyvek pouch. Stryker Sustainability Solutions received complaints reporting EP catheter devices with compromised sterile packaging. Affected lot numbers exceed 10; healthcare providers are advised to contact the manufacturer for specific lot information and next steps.

Revolution Ascend CT Security Vulnerability Recall

Health Canada issued a Type II medical device recall for GE Healthcare Japan Corporation's Revolution Ascend CT systems due to a potential security vulnerability in the AW server deployed via Edison Health Link (EHL) based CT smart subscription. Three lots are affected: AS10G2400087YC, AS10G2400056YC, and AS10G2400081YC, all with model/catalogue number 00840682146173. Healthcare providers using these devices should contact the manufacturer for additional information regarding the cybersecurity vulnerability.

Dexcom G7 iOS CGM App Type II Recall - Display Flicker Issue

Health Canada issued a Type II medical device recall for Dexcom G7 iOS CGM App versions 2.9.0 to 2.11.2 (model SW12300). The affected apps display a flicker that sequentially shows previous Estimated Glucose Values before displaying the current reading. Users are advised to contact Dexcom, Inc. for additional information. The recall was published April 14, 2026, with recall date April 9, 2026.

Nitrous Oxide Chargers: Sold for Inhalation Without Market Authorization

Health Canada has issued a Type I recall for PUR GAS Cream Charger nitrous oxide products sold without Drug Identification Number (DIN) market authorization. The products, sold in multiple flavours including Blue Raspberry, Mango, and Grape, were marketed for inhalation purposes. Posh Glass Inc. of Calgary, Alberta is the affected company. Retailers are required to remove these products from the Canadian market.

QuickVue Dipstick Strep A Test Recalled - False Positive Results

Health Canada issued a Type II medical device recall for the QuickVue Dipstick Strep A Test (catalog 20125) manufactured by Quidel Corporation due to false positive results. Affected lots include 709509, 709487, 709503, 709684, and 233275. False positives may include faint pink lines as well as pink-to-red test lines. Healthcare providers using these tests should stop using affected lots and contact the manufacturer.

Cardinal Health Angiography Pack and Catheterization Packs Recalled

Health Canada has issued a Type I recall for Cardinal Health Angiography Pack and Catheterization Pack products. The recall affects model numbers SCV30COP18, SCV30COPBN, SCV30COPBO, and SAN30LHTHC. The issue stems from Namic Angiographic Rotating Adaptor (RA) Control Syringes included in these products, which may unwind during use and cause disconnection. Healthcare providers should immediately identify and stop using affected products and contact Cardinal Health for replacement or additional information.

Stryker InZone Detachment System Type II Recall - Battery Drain

Health Canada issued a Type II recall for Stryker Neurovascular's InZone Detachment System. Certain device lots may experience premature battery drain, causing devices to fail to power on, display faint indicators, or be unable to detach coils as intended. Healthcare providers should contact Stryker Neurovascular at 47900 Bayside Parkway, Fremont, CA 94538 to verify affected lot numbers and obtain additional information.

Apo-Fluoxetine Recalled Due to Impurities Out of Specification

Health Canada has issued a Type III health product recall for Apo-Fluoxetine 10mg and 20mg capsules by Apotex Inc. due to impurities being out of specification and out of trend. The recall affects retailer-level distribution. Affected lots include VM4608, VM4612 (20mg) and VM4598 (10mg). Patients with affected product should verify their medication and consult healthcare providers before making any changes to their treatment.

Medline Neuro Sponges Recall - Elevated Endotoxin Risk

Health Canada issued a Type II recall for Medline Neuro Sponges (Gauze Sponges, X-Ray Detectable) due to potential out-of-specification endotoxin levels. Affected products include all lots of eight model numbers (NEUROSPNG05, 02, 13, 06, 07, 14, 09, 11). Elevated endotoxin levels may require medical or surgical intervention, though the likelihood of adverse health consequences is considered remote. Healthcare facilities must destroy recalled products immediately.

Health Canada Warns Against Unauthorized Injectable Peptides

Health Canada issued a public advisory warning consumers about serious health risks of unauthorized injectable peptide drugs sold online. The advisory identifies 14 specific peptides including BPC-157, Melanotan, TB-500, CJC-1295, and Retatrutide that have been seized as illegal health products. These products marketed for anti-aging, bodybuilding, weight loss, or wellness lack Health Canada safety, efficacy, and quality assessment.

Medline ENFit G-Tube Connector Recall - Type II

Health Canada issued a Type II recall for Medline ENFit G-Tube Connectors (ENFIT1010GC) across all lots due to dimensional manufacturing defects. The non-compliant connectors may fail to form proper seals with ENFit devices, causing leakage and potentially delaying patient care during medication administration. Healthcare providers must identify and destroy affected products.

Nucletron B.V. Intrauterine Tube Recall - Tip Detachment

Health Canada issued a Type II medical device recall for Nucletron B.V. Intrauterine Tubes (catalog numbers 152019-00 through 126015-01) affecting 44 product lots. The recall addresses a safety concern where the tip of the 4mm diameter IU tube detached and remained within a patient during use. Healthcare providers should contact the manufacturer for additional information.

ACE Surgical sutures recall due to unlicensed medical devices

Health Canada issued a Type II recall for ACE Surgical Supply® PGA Absorbable Sutures and Absorbable Gut Sutures distributed in Canada. BioHorizons Canada is conducting the recall because manufacturer ACE Surgical Supply Co. Inc. voluntarily ceased operations and discontinued its medical device licenses in Canada, resulting in unlicensed devices on the market. All lots of 17 affected catalogue numbers are subject to this recall. Healthcare providers who have distributed these sutures must cease use and contact the importer.

Medline Convenience Kits containing Namic RA Syringes recall - death risk

Health Canada issued a Type I recall for Medline Convenience Kits containing Namic RA Syringes due to a potential risk of the syringe rotating adaptor unwinding during use, which may cause procedural delays or, in severe cases, death. Multiple lot numbers across angiographic kits, convenience kits, and tumescent syringe kits are affected. Healthcare providers have been advised to immediately stop using and discard the affected syringes.

Medline Angiographic Kit Recall - Syringe Adaptor Unwinding Risk

Health Canada issued a Type I recall for Medline Namic Custom Angiographic Kits (catalog numbers 60700513, 60701152, 60700465) due to potential risk of the syringe rotating adaptor unwinding during use, which may cause procedural delays or death. Healthcare facilities must immediately stop using affected Namic RA Syringes and discard them. Recall identification number RA-81841.

Aved Products Recall - Unauthorized Ophthalmic Solutions

Health Canada issued a Type III recall for Aved ophthalmic solutions from Labtician Ophthalmics, Inc. Nine products were sold without market authorization (DIN) in Canada due to third-party branding issues. Affected products include various atropine sulfate solutions (0.01%-0.05%), fluorescein/proparacaine, insulin ophthalmic, mitomycin, moxifloxacin, and combination steroid/antibiotic solutions. Distribution is national in Canada with recall classification RA-81839.

Olympus Connecting Tubes Premature Failure Recall

Health Canada issued a Type II medical device recall for Olympus Medical Systems Corp. connecting tubes (models MAJ-2110 through MAJ-2330) due to premature failure where lock levers detach or break earlier than expected in Version 2 products. Olympus will remove prior versions from the market and replace them with the current design. Affected parties should identify, quarantine, and contact the manufacturer for replacement.

AneurysmFlow Medical Device Recall - Unreliable mafa Ratio

Health Canada issued a Type II recall for AneurysmFlow software (Model 1.4) manufactured by Philips Medical Systems Nederland B.V. The recall addresses unreliable mafa ratio measurements that provide inaccurate prognostic information for aneurysm occlusion following flow diverter stent treatment. Despite existing cautions in the instructions for use, the displayed mafa ratio may still influence intraprocedural clinical decisions, potentially resulting in incorrect patient treatment choices.

Dimension Creatinine CRE2 Medical Device Recall

Health Canada issued a Class Type II medical device recall for Siemens Healthineers Dimension® Creatinine (CRE2) diagnostic reagents due to potential imprecision in quality control and patient sample results. Affected lots GA6307 and BA7005 (catalog 10872079) may produce inaccurate creatinine measurements on the Dimension system. Healthcare facilities using these products should immediately quarantine affected inventory and contact Siemens for return or replacement options.

Edwards EVOQUE Tricuspid Delivery System Labelling Recall

Health Canada issued a Type II voluntary recall for Edwards EVOQUE Tricuspid Delivery System (Model 9850TDS) affecting all lots. This labeling correction does not require product return but is intended to update device labeling to support proper use and optimal performance. Healthcare providers using this device should review updated labeling materials.

Jamieson Laboratories Products Recall - Defective Tamper-Evident Seals

Health Canada issued a Type III recall for Jamieson Laboratories three natural health product capsule lines due to potentially defective tamper-evident seals. Affected products include Joint pain relief capsules (NPN 80140241, lot 70794), Magnesium bisglycinate Capsules (NPN 80131651, 12 lots), and Maca capsules (NPN 80134082, 3 lots). The recall depth extends to wholesalers and retailers. No compliance deadline or penalties are specified.

Health First Vitamin E Recall - Undeclared Active Ingredient

Health Canada issued a Type III recall for Health First Vitamin E capsules (NPN 80089888, lots 14042 and HL2252701) distributed by Health First Network in Hamilton, Ontario. The recall affects retailers and targets products containing an undeclared active ingredient. Consumers are advised to consult healthcare providers before discontinuing use. The recall was initiated on April 1, 2026.

Flamingo Funnel Medical Device Recall - Sterility Loss Risk

Health Canada issued a Type II recall for Flamingo Funnel™ medical devices (lots 8264501, 8264601, 8264701, model SQ-20012-01) manufactured by Nascent Surgical D/B/A SurgiSmoke Solutions. The recall was initiated due to a packaging defect where a non-gamma-compatible drape degraded under heat, causing pinholes and potential loss of sterility. Healthcare providers must immediately stop using affected lots and dispose per national and local regulations.

Kiwi Vacuum Assisted Delivery System Recall - Breakage Hazard

Health Canada issued a Type II recall for Clinical Innovations' Kiwi® Vacuum Assisted Delivery System (model VAC-6000MT) due to a breakage hazard at the Traction Force Indicator joint during use. The device may break when traction is applied at approximately a 45-degree angle, posing a risk during obstetric procedures. Manufacturers will contact affected customers with instructions for product return.

B. Braun Hemodialysis Blood Tubing Set Recall - Air Bubble Risk

Health Canada issued a Type II recall for B. Braun Hemodialysis Blood Tubing Sets (models B3-4630M4705 and B3-3632M3705) due to potential accumulation of small air bubbles in the arterial line caused by adherence of blood gases to tubing under negative pressure. All lots are affected. Healthcare providers should immediately identify and remove affected products from use and contact the manufacturer for return or replacement instructions.

DermaHealer UVB Light Therapy Lamps Recalled for Lacking Canadian Medical Device Licence

Health Canada issued a Type II recall for DermaHealer UVB Light Therapy Lamps (Handheld and Compact models) distributed in Canada without required Canadian Medical Device Licence. The products were sold to customers across Canada by manufacturer DermaHealer USA/UAB FavouritePlus of Tualatin, Oregon. No specific lot or model numbers are available; customers must contact the manufacturer for identification.

Ultraview SL Command Module Cardiac Output Defect Recall

Health Canada issued a Type II recall for Spacelabs Healthcare's Ultraview SL™ Command Module (model 91496) after production testing discovered the cardiac output function was intermittently yielding bad or irregular curves. Healthcare providers using this multiparameter module should contact the manufacturer for lot information and assess any affected devices in their facilities.

Auro-Canagliflozin Recall - Incorrect DIN on Blister Cards

Health Canada issued a Type III recall for Auro-Canagliflozin 300mg tablets (DIN 02510375) manufactured by Auro Pharma Inc. due to incorrect Drug Identification Number on blister cards. Affected lots XQ3025001A and XQ3025004A are impacted. The recall applies to wholesalers with a depth limited to wholesale distribution.

LUXA-D Recall - Foreign Capsule Found in Affected Batch

Jamp Pharma is recalling one batch of LUXA-D 2000 units capsules (Lot S2520177, DIN 02442256) from the Canadian market after a capsule containing a foreign product was found in the affected batch. The recall affects wholesalers at the distribution level. Healthcare providers and patients who have this product should verify their inventory and consult their healthcare provider before discontinuing use.

Moxifloxacin ophthalmic solution recall due to assay out of trend

Health Canada issued a Type II recall for pms-MOXIFLOXACIN HCL 0.5% Ophthalmic Solution (DIN 02432218, Lot 240518) distributed nationally by Pharmascience. The recall was triggered because the assay is out of trend for the affected lot. Healthcare providers and consumers should verify if they have the affected product and consult with healthcare professionals before discontinuing use.

Cardinal Health EP Packs Type I Recall

Health Canada issued a Type I medical device recall for Cardinal Health Cardiac Electrophysiology (EP) Packs containing potentially affected Medline Namic Angiographic Control Syringes. The recall addresses a risk that the syringe rotating adaptor may unwind during use, causing loose connection or full disconnection between the syringe and manifold. Affected products include lots 479584 and 473022 with model number SAN30EP'XXX'.

Medline Namic Angiographic Control Syringes Recalled Due to Unwinding Risk

Health Canada has issued a Type I recall for Medline Namic Angiographic Control Syringes due to a risk of the syringe rotating adaptor unwinding during use, which could lead to procedural delays or death. Healthcare professionals are advised to contact the manufacturer for more information and to destroy affected products.

HIZENTRA solution recalled due to appearance out of specification

Health Canada has issued a recall for the HIZENTRA solution due to an appearance out of specification in lot P100834477. The recall is classified as Type II, indicating a low risk to health. End users are advised to consult healthcare providers before discontinuing use.

Health Canada Seizes Unauthorized Counterfeit Health Products in Mississauga

Health Canada issued a public advisory regarding the seizure of unauthorized and counterfeit health products, including prescription drugs and injectables, from a Mississauga location. These products have not been assessed for safety, efficacy, or quality and pose serious health risks.

iVascular Navitian Recall

Health Canada has issued a Type II recall for the iVascular Navitian medical device due to a potential risk of material fragment loss from outer layer deterioration. The recall affects specific lot and serial numbers and is being managed by the manufacturer, Life Vascular Devices Biotech S.L.

Olympus HF Cable Recall

Health Canada has issued a Type II recall for the Olympus HF Cable (Model WA00014A) due to performance issues leading to insulation wear, corrosion, and failure. The recall follows 109 complaints, including 17 reports of minor burns, though no serious injuries were reported.

Health Canada: Nitrous Oxide Chargers Sold for Inhalation Without Authorization

Health Canada has issued a recall for Nitrous Oxide Chargers sold by Polar Imports Canada for inhalation without market authorization. The agency warns consumers not to inhale these products for recreational purposes and to seek medical attention if side effects occur.

UniCel DxI 600 Total T4 Assay Recall

Health Canada has issued a Type II recall for the UniCel DxI 600 Access Immunoassay System-Total T4 Assay due to a negative bias that can cause false low patient results. The recall affects specific lot numbers and poses a medium safety risk. Healthcare providers are advised to contact the manufacturer for further information.

Ortho Connect Medical Device Recall for Incorrect Test Results

Health Canada has issued a Type II recall for the Ortho Connect medical device manufactured by Biomedical Data Solutions Limited due to the potential for incorrect test results. The recall affects specific lot and model numbers, with a recall date of February 19, 2026.

Angiographic Catheters Recalled Due to Molded Hub Non-Conformance

Health Canada has issued a recall for AngioDynamics' Soft-Vu and Accu-Vu 4 FR Angiographic Catheters due to a molded hub non-conformance. The defect may prevent guidewire passage, though no injuries have been reported in Canada. Healthcare providers should contact the manufacturer for information.

Health Canada Recalls Vacuum Bag SU Large Due to Leakage Risk

Health Canada has issued a Type II recall for the Milestone S.R.L. Vacuum Bag SU Large due to a risk of leakage from the specimen container. Healthcare providers are advised to contact the manufacturer for additional information.

Health Canada Recalls Disinfectant Spray & Wipe Cleaner

Health Canada has issued a recall for specific lots of Coastwide CP15 Disinfectant Spray & Wipe Cleaner due to the active ingredient strength not meeting the labelled concentration. Retailers are instructed on the depth of the recall, and consumers are advised on actions to take.

Philips Recalls Allura Xper/Azurion Systems for X-ray Imaging Issues

Health Canada issued a recall for Philips Allura Xper and Azurion X-ray imaging systems due to performance issues with the wired foot switch. The recall affects multiple models and advises healthcare providers to contact the manufacturer for additional information.

Medical Device Recall: Incorrect Expiration Dates

Health Canada has issued a recall for several medical devices, including the Approach® CTO Micro Wire Guide and various catheter sets, due to incorrect expiration dates on the labelling. The manufacturer, Cook Incorporated, is providing information to healthcare professionals. This recall impacts multiple lot and model numbers.

Health Canada Recalls GEM PAKs for GEM Premier 5000 Due to Errors

Health Canada has issued a recall for GEM PAKs used with the GEM Premier 5000 due to an increased incidence of 'Process Control Solution Not Detected' errors. These errors can lead to GEM PAK ejection and require replacement, potentially delaying patient management.

Siemens RAPIDPoint 500 Blood Gas Systems Recall

Health Canada has issued a Type II recall for Siemens RAPIDPoint 500 Blood Gas Systems due to Measurement Cartridges potentially being exposed to temperatures outside specified storage conditions during transport. This may affect cartridge performance, and affected healthcare providers should contact the manufacturer.