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Found 12,722 results for "product recalls and alerts"
FDA DevicesBARD Dynamic XT Steerable, Product Number 201103, REPROCESSED ELECTROPHYSIOLOGY CATHETER
BARD Dynamic XT Steerable, Product Number 201103, REPROCESSED ELECTROPHYSIOLOGY CATHETER
Incomplete seals on sterile product
Health CanadaPersonnelle Supravite Energizing Formula: The breakage of vials can generate glass fragments
Personnelle Supravite Energizing Formula: The breakage of vials can generate glass fragments
Product quality
FDA DevicesNamic Preceptor Manifold, custom, Medline Product Number/SKU 64039307; Extravascular blood pressure transducer
Namic Preceptor Manifold, custom, Medline Product Number/SKU 64039307; Extravascular blood pressure transducer
Medline has identified the presence of particulate within the fluid path of the Manifolds.
FDA DevicesDaig Livewire Steerable BDB, Product Number 401918, REPROCESSED ELECTROPHYSIOLOGY CATHETER
Daig Livewire Steerable BDB, Product Number 401918, REPROCESSED ELECTROPHYSIOLOGY CATHETER
Incomplete seals on sterile product
FDA DevicesBrand Name: Dexcom G7 Continuous Glucose Monitoring System Product Name: Dexcom G7 CGM watchOS App Model/Catalog Number: SW13355 Software Version: Versions 2.9.0 through 2.11.2 Product Description: Dexcom G7 CGM watchOS App - The watchOS app is installed along with the iOS phone app and the versions used are the same for each user. The watchOS app cannot be installed independently from the iOS phone app. Component: Dexcom G7 Continuous Glucose Monitoring System, Dexcom G7 15 Day Continuous Glucose Monitoring System
Brand Name: Dexcom G7 Continuous Glucose Monitoring System Product Name: Dexcom G7 CGM watchOS App Model/Catalog Number: SW13355 Software Version: Versions 2.9.0 through 2.11.2 Product Description: Dexcom G7 CGM watchOS App - The watchOS app is installed along with the iOS phone app and the versions used are the same for each user. The watchOS app cannot be installed independently from the iOS phone app. Component: Dexcom G7 Continuous Glucose Monitoring System, Dexcom G7 15 Day Continuous Glucose Monitoring System
A software defect in which a low-priority file I/O check blocks the higher-priority thread responsible for processing estimated glucose values (EGVs) and trend arrows. When the app is running in the background, EGV notifications may queue up and then "replay" sequentially when the user brings the app to the foreground, causing the Glucose Compass to flicker through previous EGVs. In more severe instances, the app may perceive signal loss and deploy signal loss mitigations. This delay in EGV and alert processing creates a risk that users may miss detection of a hypoglycemic or hyperglycemic event, or make treatment decisions based on outdated glucose information.
FDA DevicesDaig Livewire Steerable, Product Number 401908; REPROCESSED ELECTROPHYSIOLOGY CATHETER
Daig Livewire Steerable, Product Number 401908; REPROCESSED ELECTROPHYSIOLOGY CATHETER
Incomplete seals on sterile product
Health CanadaSprings Cellular Shades recalled due to choking hazard
Springs Cellular Shades recalled due to choking hazard
Choking hazard
FDA DevicesBrand Name: Dexcom ONE+ Continuous Glucose Monitoring System Product Name: Dexcom ONE+ iOS CGM App Model/Catalog Number: SW14244 Software Version: versions 1.5.0 and 1.6.0 Product Description: Dexcom ONE+ iOS CGM App Component: Dexcom ONE+ Continuous Glucose Monitoring System
Brand Name: Dexcom ONE+ Continuous Glucose Monitoring System Product Name: Dexcom ONE+ iOS CGM App Model/Catalog Number: SW14244 Software Version: versions 1.5.0 and 1.6.0 Product Description: Dexcom ONE+ iOS CGM App Component: Dexcom ONE+ Continuous Glucose Monitoring System
A software defect in which a low-priority file I/O check blocks the higher-priority thread responsible for processing estimated glucose values (EGVs) and trend arrows. When the app is running in the background, EGV notifications may queue up and then "replay" sequentially when the user brings the app to the foreground, causing the Glucose Compass to flicker through previous EGVs. In more severe instances, the app may perceive signal loss and deploy signal loss mitigations. This delay in EGV and alert processing creates a risk that users may miss detection of a hypoglycemic or hyperglycemic event, or make treatment decisions based on outdated glucose information.
FDA DevicesBARD Dynamic Tip Steerable, Product Number 200131; REPROCESSED ELECTROPHYSIOLOGY CATHETER
BARD Dynamic Tip Steerable, Product Number 200131; REPROCESSED ELECTROPHYSIOLOGY CATHETER
Incomplete seals on sterile product
FDA DevicesCS Uni-Directional w Auto ID, Product Number D135304; REPROCESSED ELECTROPHYSIOLOGY CATHETER
CS Uni-Directional w Auto ID, Product Number D135304; REPROCESSED ELECTROPHYSIOLOGY CATHETER
Incomplete seals on sterile product
Health CanadaERYTHROMYCIN OPHTHALMIC OINTMENT USP: The sterility of the product could be compromised.
ERYTHROMYCIN OPHTHALMIC OINTMENT USP: The sterility of the product could be compromised.
Product quality
FDA DevicesDaig Livewire Steerable, Product Number 401652; REPROCESSED ELECTROPHYSIOLOGY CATHETER
Daig Livewire Steerable, Product Number 401652; REPROCESSED ELECTROPHYSIOLOGY CATHETER
Incomplete seals on sterile product
FDA DevicesArrow Edge Hemodialysis Catheterization Product, REF: CS-15242-I, CS-15282-I, CS-15322-I
Arrow Edge Hemodialysis Catheterization Product, REF: CS-15242-I, CS-15282-I, CS-15322-I
16F dual-valved splittable sheath introducer, the subject of a supplier recall, was included in impacted hemodialysis kits & sets. Sheath introducer may not split as intended, and may result in withdrawal resistance, prolonged procedure time, pain, bleeding, hematoma, tissue injury, vessel wall injury.
FDA DevicesNamic Angiographic Manifold, custom, Medline Product Number/SKU 64038200; Cardiopulmonary bypass adaptor, stopcock, manifold, or fitting.
Namic Angiographic Manifold, custom, Medline Product Number/SKU 64038200; Cardiopulmonary bypass adaptor, stopcock, manifold, or fitting.
Medline has identified the presence of particulate within the fluid path of the Manifolds.
FDA DevicesNamic Angiographic Manifold, custom, Medline Product Number/SKU 64038301; Cardiopulmonary bypass adaptor, stopcock, manifold, or fitting.
Namic Angiographic Manifold, custom, Medline Product Number/SKU 64038301; Cardiopulmonary bypass adaptor, stopcock, manifold, or fitting.
Medline has identified the presence of particulate within the fluid path of the Manifolds.
Health CanadaChildren’s Glow in the dark bath robes recalled due to flammability hazard
Children’s Glow in the dark bath robes recalled due to flammability hazard
Flammability hazard
Health Canada1-K Kerosene Heater Fluid Portable Fuel Containers recalled due to fire hazard
1-K Kerosene Heater Fluid Portable Fuel Containers recalled due to fire hazard
Fire hazard
Health CanadaHonibe Honey Gummies - Melatonin: Daily recommended intake may cause the active ingredient to exceed the allowable limit.
Honibe Honey Gummies - Melatonin: Daily recommended intake may cause the active ingredient to exceed the allowable limit.
Product quality
Health CanadaAsung Trading Inc. products recalled due to missing mandatory hazard labelling
Asung Trading Inc. products recalled due to missing mandatory hazard labelling
Labelling and packaging
Health CanadaZwilling Enfinigy Electric Kettle and Zwilling Enfinigy Electric Kettle Pro recalled due to burn hazard
Zwilling Enfinigy Electric Kettle and Zwilling Enfinigy Electric Kettle Pro recalled due to burn hazard
Burn hazard
Health CanadaCertain Petzl SIMBA and SWAN harnesses recalled due to fall hazard
Certain Petzl SIMBA and SWAN harnesses recalled due to fall hazard
Fall hazard
Health CanadaPetzl ASTRO and CANYON GUIDE Harnesses recalled due to fall hazard
Petzl ASTRO and CANYON GUIDE Harnesses recalled due to fall hazard
Fall hazard
Health CanadaGenerac power electric start pressure washers recalled due to carbon monoxide poisoning hazard
Generac power electric start pressure washers recalled due to carbon monoxide poisoning hazard
Poisoning hazard
Health CanadaHARPPA Wooden Baby Playpen Gate recalled due to choking and injury hazards
HARPPA Wooden Baby Playpen Gate recalled due to choking and injury hazards
Choking hazard - Injury hazard