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Safety Alert
Health Canada
Health CanadaTransport Canada Recall - 2026046 - JOHN DEERE
TC
Health CanadaGeneral Alert
Transport Canada Recall - 2026046 - JOHN DEERE
Other
Feb 12, 2026TC
Safety AlertHealth Canada
Health CanadaCertain Stellar Bay Shellfish brand Oysters recalled due to norovirus
CFIA
Health CanadaClass 2
Certain Stellar Bay Shellfish brand Oysters recalled due to norovirus
Norovirus
Feb 12, 2026CFIA
Vehicle Recall
NHTSA
NHTSAInternational Motors, LLC - Brakes May Fail to Activate with Adaptive Cruise Control
International Motors, LLC
NHTSAFORWARD COLLISI...
International Motors, LLC - Brakes May Fail to Activate with Adaptive Cruise Control
A vehicle that does not automatically brake as expected increases the risk of a crash.
Feb 12, 2026International Motors, LLC
Medical DeviceFDA Devices
FDA DevicesPRISMAFLEX TPE2000 SET, Product Code 114093; Dialyzer, High Permeability With Or Without Sealed Dialysate System
VANTIVE US HEALTHCARE LLC
FDA DevicesClass II
PRISMAFLEX TPE2000 SET, Product Code 114093; Dialyzer, High Permeability With Or Without Sealed Dialysate System
There is a potential dislodgement of the Prismaflex Set deaeration chamber from the Prismaflex Control Unit.
Feb 11, 2026VANTIVE US HEALTHCARE LLC
Medical DeviceFDA Devices
FDA DevicesProduct Name: Single Use 3-Lumen Sphincterotome V Model/Catalog Number: KD-V411M-3030 Product Description: These instruments have been designed to be used with an Olympus endoscope and guidewire for papillotomy using high-frequency current.
Olympus Corporation of the Americas
FDA DevicesClass II
Product Name: Single Use 3-Lumen Sphincterotome V Model/Catalog Number: KD-V411M-3030 Product Description: These instruments have been designed to be used with an Olympus endoscope and guidewire for papillotomy using high-frequency current.
Devices which did not undergo thermoforming could deform and lose performance.
Feb 11, 2026Olympus Corporation of the Americas
Medical DeviceFDA Devices
FDA DevicesProduct Name: Single Use 3-Lumen Sphincterotome V Model/Catalog Number: KD-V411M-3020 Product Description: These instruments have been designed to be used with an Olympus endoscope and guidewire for papillotomy using high-frequency current.
Olympus Corporation of the Americas
FDA DevicesClass II
Product Name: Single Use 3-Lumen Sphincterotome V Model/Catalog Number: KD-V411M-3020 Product Description: These instruments have been designed to be used with an Olympus endoscope and guidewire for papillotomy using high-frequency current.
Devices which did not undergo thermoforming could deform and lose performance.
Feb 11, 2026Olympus Corporation of the Americas
Medical DeviceFDA Devices
FDA DevicesMiniMed 780G Insulin Pump Catalog Numbers: MMT-1884 MMT-1886 With Software Version 6.60 The MiniMed 780G insulin pump is indicated for use by patients age 7-80 years with Type 1 diabetes, whose total daily dose of insulin is 8 units per day or more. The MiniMed 780G system is intended for continuous delivery of basal insulin at selectable rates, and the administration of insulin boluses at selectable amounts for the management of type 1 diabetes mellitus in persons seven years of age and older requiring insulin. The system is also intended to continuously monitor glucose values in the fluid under the skin. The MiniMed 780G system includes SmartGuard technology, which can be programmed to automatically adjust insulin delivery based on continuous glucose monitoring (CGM) sensor glucose values and can suspend delivery of insulin when the SG value falls below or is predicted to fall below predefined threshold values.
Medtronic MiniMed, Inc.
FDA DevicesClass II
MiniMed 780G Insulin Pump Catalog Numbers: MMT-1884 MMT-1886 With Software Version 6.60 The MiniMed 780G insulin pump is indicated for use by patients age 7-80 years with Type 1 diabetes, whose total daily dose of insulin is 8 units per day or more. The MiniMed 780G system is intended for continuous delivery of basal insulin at selectable rates, and the administration of insulin boluses at selectable amounts for the management of type 1 diabetes mellitus in persons seven years of age and older requiring insulin. The system is also intended to continuously monitor glucose values in the fluid under the skin. The MiniMed 780G system includes SmartGuard technology, which can be programmed to automatically adjust insulin delivery based on continuous glucose monitoring (CGM) sensor glucose values and can suspend delivery of insulin when the SG value falls below or is predicted to fall below predefined threshold values.
A software timing and processor communication issue in MiniMed" 780G software version 6.60 may trigger Pump Error 43 and/or Pump Error 41, resulting in suspension of insulin delivery.
Feb 11, 2026Medtronic MiniMed, Inc.
Food & BeverageFDA Food
FDA FoodSea Moss Gel Superfood; 16 FL OZ; Glass jar sold individually. Pineapple- UPC# 5065006235288
Diva Fam Inc
FDA FoodClass II
Sea Moss Gel Superfood; 16 FL OZ; Glass jar sold individually. Pineapple- UPC# 5065006235288
potential Clostridium botulinum contamination
Feb 11, 2026Diva Fam Inc
Medical DeviceFDA Devices
FDA DevicesPRISMAFLEX HF1000 SET, Product Code 107140; Dialyzer, High Permeability With Or Without Sealed Dialysate System
VANTIVE US HEALTHCARE LLC
FDA DevicesClass II
PRISMAFLEX HF1000 SET, Product Code 107140; Dialyzer, High Permeability With Or Without Sealed Dialysate System
There is a potential dislodgement of the Prismaflex Set deaeration chamber from the Prismaflex Control Unit.
Feb 11, 2026VANTIVE US HEALTHCARE LLC
Medical DeviceFDA Devices
FDA DevicesBrand Name: Disposable Triple Lumen Sphincterotome Product Name: Disposable Triple Lumen Sphincterotome Model/Catalog Number: KD-401Q-0320 Product Description: These instruments have been designed to be used with an Olympus endoscope and guidewire for papillotomy using high-frequency current.
Olympus Corporation of the Americas
FDA DevicesClass II
Brand Name: Disposable Triple Lumen Sphincterotome Product Name: Disposable Triple Lumen Sphincterotome Model/Catalog Number: KD-401Q-0320 Product Description: These instruments have been designed to be used with an Olympus endoscope and guidewire for papillotomy using high-frequency current.
Devices which did not undergo thermoforming could deform and lose performance.
Feb 11, 2026Olympus Corporation of the Americas
Medical DeviceFDA Devices
FDA DevicesBrand Name: Single Use Electrosurgical Knife Product Name: Olympus Single Use Electrosurgical Knife KD-640L Model/Catalog Number: KD640-L Product Description: An electrosurgical device consisting of a handpiece with mechanical and/or electrical controls, and a monopolar electrode, intended to deliver a current from a system generator directly to tissues for cutting/coagulation/ablation during endoscopic (including laparoscopic, arthroscopic) surgery.
Olympus Corporation of the Americas
FDA DevicesClass II
Brand Name: Single Use Electrosurgical Knife Product Name: Olympus Single Use Electrosurgical Knife KD-640L Model/Catalog Number: KD640-L Product Description: An electrosurgical device consisting of a handpiece with mechanical and/or electrical controls, and a monopolar electrode, intended to deliver a current from a system generator directly to tissues for cutting/coagulation/ablation during endoscopic (including laparoscopic, arthroscopic) surgery.
A deterioration of the cutting knife, including overheating and burning, can contribute to tip breakage during use.
Feb 11, 2026Olympus Corporation of the Americas
Medical DeviceFDA Devices
FDA DevicesNAEOTOM Alpha.Prime Software applications: syngo.CT Brain Quantification syngo.CT Vessel Hyperdensities syngo.CT ASPECTS
Siemens Medical Solutions USA, Inc
FDA DevicesClass II
NAEOTOM Alpha.Prime Software applications: syngo.CT Brain Quantification syngo.CT Vessel Hyperdensities syngo.CT ASPECTS
To remove the software applications from certain CT systems as the applications have not received FDA 510(k) clearance.
Feb 11, 2026Siemens Medical Solutions USA, Inc
Medical DeviceFDA Devices
FDA DevicesProduct Name: Single Use 3-Lumen Sphincterotome V Model/Catalog Number: KD-V411M-0330; Software Version: N/A Product Description: These instruments have been designed to be used with an Olympus endoscope and guidewire for papillotomy using high-frequency current.
Olympus Corporation of the Americas
FDA DevicesClass II
Product Name: Single Use 3-Lumen Sphincterotome V Model/Catalog Number: KD-V411M-0330; Software Version: N/A Product Description: These instruments have been designed to be used with an Olympus endoscope and guidewire for papillotomy using high-frequency current.
Devices which did not undergo thermoforming could deform and lose performance.
Feb 11, 2026Olympus Corporation of the Americas
Medical DeviceFDA Devices
FDA DevicesProduct Name: Disposable Triple Lumen Sphincterotome Model/Catalog Number: KD-411Q-0720 Product Description: These instruments have been designed to be used with an Olympus endoscope and guidewire for papillotomy using high-frequency current.
Olympus Corporation of the Americas
FDA DevicesClass II
Product Name: Disposable Triple Lumen Sphincterotome Model/Catalog Number: KD-411Q-0720 Product Description: These instruments have been designed to be used with an Olympus endoscope and guidewire for papillotomy using high-frequency current.
Devices which did not undergo thermoforming could deform and lose performance.
Feb 11, 2026Olympus Corporation of the Americas
Medical DeviceFDA Devices
FDA DevicesVortex Surgical I2 Injection Kit, VS0500
Vortex Surgical Inc.
FDA DevicesClass II
Vortex Surgical I2 Injection Kit, VS0500
There may be voids located in the seal of Tyvek pouches associated with identified catalog numbers and lots. A compromised sterile barrier has potential of bioburden contamination which could lead to infection.
Feb 11, 2026Vortex Surgical Inc.
Food & Beverage
RappelConso
RappelConsosatyva - skywalker
satyva
RappelConsovolontaire (san...
satyva - skywalker
etiquetage non conforme : absence de traçabilité et de numéro de lot, absence de composition et absence de recommandation d'utilisation sur le conditionnement
Feb 11, 2026satyva
Food & BeverageRappelConso
RappelConsoferme du bois de boulle - conserves de lapin
ferme du bois de boulle
RappelConsovolontaire (san...
ferme du bois de boulle - conserves de lapin
perte de maitrise du process de sterilisation
Feb 11, 2026ferme du bois de boulle
Food & BeverageRappelConso
RappelConsoferme du bois de boulle - conserves de lapin
ferme du bois de boulle
RappelConsovolontaire (san...
ferme du bois de boulle - conserves de lapin
perte de maitrise du process de sterilisation
Feb 11, 2026ferme du bois de boulle
Food & BeverageRappelConso
RappelConsofournil de la barre - conserves de volailles
fournil de la barre
RappelConsovolontaire (san...
fournil de la barre - conserves de volailles
perte de maitrise du process de sterilisation
Feb 11, 2026fournil de la barre
Food & BeverageRappelConso
RappelConsola ferme aux biches - conserves de cerf
la ferme aux biches
RappelConsovolontaire (san...
la ferme aux biches - conserves de cerf
perte de maitrise du process de sterilisation
Feb 11, 2026la ferme aux biches
Food & BeverageRappelConso
RappelConsonamli - domates salcasi
namli
RappelConsovolontaire (san...
namli - domates salcasi
des produits interdits ont été utilisé pour la conception du produit
Feb 11, 2026namli
Medical DeviceFDA Devices
FDA DevicesProduct Name: Single Use 3-Lumen Sphincterotome V Model/Catalog Number: KD-V431M-0720; Software Version: N/A Product Description: These instruments have been designed to be used with an Olympus endoscope and guidewire for papillotomy using high-frequency current.
Olympus Corporation of the Americas
FDA DevicesClass II
Product Name: Single Use 3-Lumen Sphincterotome V Model/Catalog Number: KD-V431M-0720; Software Version: N/A Product Description: These instruments have been designed to be used with an Olympus endoscope and guidewire for papillotomy using high-frequency current.
Devices which did not undergo thermoforming could deform and lose performance.
Feb 11, 2026Olympus Corporation of the Americas
Food & BeverageRappelConso
RappelConsoagroburkina - aubergine blanche
agroburkina
RappelConsovolontaire (san...
agroburkina - aubergine blanche
dépassement de la limite réglementaire en résidu de pesticide (chlorpyrifos).
Feb 11, 2026agroburkina
Medical DeviceFDA Devices
FDA DevicesFDR Visionary Suite; Model Number: CH-200; Version: (1) 566-16130-23, (2) 566-16130-31, (3)
FUJIFILM Healthcare Americas Corporation
FDA DevicesClass II
FDR Visionary Suite; Model Number: CH-200; Version: (1) 566-16130-23, (2) 566-16130-31, (3)
It was found that the contacts of the electromagnetic contactors used inside the cabinet of the X-ray high-voltage generator were welded, and the current might continue to be supplied to the power supply circuit even if the power of the device is cut off. As a result, it cannot be denied that the circuit in question overheats and damages the surrounding parts. It may also cause smoke.
Feb 11, 2026FUJIFILM Healthcare Americas Corporation