Safety Recall Directory
Browse and filter the latest official safety alerts globally.
FDA DevicesAllura Xper FD10; Model Number: 722010;
Allura Xper FD10; Model Number: 722010;
Philips has identified that in a limited number of impacted systems the drip tray beneath the cooling unit was not installed under previous field corrections, or evidence of the implementation was not adequately documented. If it is not installed, there is a potential for coolant liquid to contact electrical components. This could lead to electrical short-circuits, which may trigger system fuses and result in system shutdown.
FDA DevicesAllura Xper FD20/20; Model Number: 722038;
Allura Xper FD20/20; Model Number: 722038;
Philips has identified that in a limited number of impacted systems the drip tray beneath the cooling unit was not installed under previous field corrections, or evidence of the implementation was not adequately documented. If it is not installed, there is a potential for coolant liquid to contact electrical components. This could lead to electrical short-circuits, which may trigger system fuses and result in system shutdown.
FDA DrugsPersonal Care, Vaporizing Chest Rub, 4 oz, 12 count, UPC 048155903319
Personal Care, Vaporizing Chest Rub, 4 oz, 12 count, UPC 048155903319
CGMP Deviations: Insanitary conditions including rodent exposure/activity in their distribution center.
FDA DevicesMAXXUS, System, Tomography, Computed, Emission
MAXXUS, System, Tomography, Computed, Emission
GE HealthCare has become aware that certain Nuclear Medicine systems that are past the End of Guaranteed Service (herein referred to as Impacted Systems and listed in the Affected Product Details section of this letter) could have been transported or relocated without adequate detector support. This could result in excessive stress being applied to the detector mounting mechanisms, compromising their integrity. If this occurs, it can potentially result in a detector fall and lead to life-threatening bodily injury. There have been no reports of detector falls or injuries as a result of this potential issue. The Impacted Systems affected by this notice are those that have not been manufactured for several years. GE HealthCare has previously communicated End of Guaranteed Service for these Impacted Systems.
FDA DrugsPEPCID COMPLETE - 25CT
PEPCID COMPLETE - 25CT
CGMP Deviations: Insanitary conditions including rodent exposure/activity in their distribution center.
FDA DevicesPlum Duo Infusion System, List Number 40002-04-01
Plum Duo Infusion System, List Number 40002-04-01
ICU Medical received one lot of defective primary speakers from our supplier that may fail to produce an audible sound. If the primary speaker in your Plum Duo Infusion Pump fails, the pump may not produce audible alarms, alerts, or provide audible feedback for touchscreen inputs.
FDA DevicesMedicrea, IB3D PL Instruments Set, Rx Only REF: SPS03174
Medicrea, IB3D PL Instruments Set, Rx Only REF: SPS03174
Due to complaints, orthopedic rotation tool handle may untread from the shaft resulting in the inability to rotate implant.
FDA DevicesSMV BodyTrack, System, Tomography, Computed, Emission
SMV BodyTrack, System, Tomography, Computed, Emission
GE HealthCare has become aware that certain Nuclear Medicine systems that are past the End of Guaranteed Service (herein referred to as Impacted Systems and listed in the Affected Product Details section of this letter) could have been transported or relocated without adequate detector support. This could result in excessive stress being applied to the detector mounting mechanisms, compromising their integrity. If this occurs, it can potentially result in a detector fall and lead to life-threatening bodily injury. There have been no reports of detector falls or injuries as a result of this potential issue. The Impacted Systems affected by this notice are those that have not been manufactured for several years. GE HealthCare has previously communicated End of Guaranteed Service for these Impacted Systems.
FDA DevicesAllura Xper FD20 Biplane; Model Number: 722008;
Allura Xper FD20 Biplane; Model Number: 722008;
Philips has identified that in a limited number of impacted systems the drip tray beneath the cooling unit was not installed under previous field corrections, or evidence of the implementation was not adequately documented. If it is not installed, there is a potential for coolant liquid to contact electrical components. This could lead to electrical short-circuits, which may trigger system fuses and result in system shutdown.
FDA DrugsDAYQUIL COLD & FLU, 32CT/2PK
DAYQUIL COLD & FLU, 32CT/2PK
CGMP Deviations: Insanitary conditions including rodent exposure/activity in their distribution center.
FDA DevicesMedline Kits containing B. Braun IV Administration Sets and Pump Administration Sets, labeled as: 1) RR-PLASTIC CRANIOFACIAL PK-LF, Medline kit SKU DYNJ0395085V; 2) NH PERI DISC PACK, Medline kit SKU DYNJ66311C; 3) DISCECTOMY PACK, Medline kit SKU DYNJ86770; 4) TOTAL KNEE, Medline kit SKU DYNJ909643F.
Medline Kits containing B. Braun IV Administration Sets and Pump Administration Sets, labeled as: 1) RR-PLASTIC CRANIOFACIAL PK-LF, Medline kit SKU DYNJ0395085V; 2) NH PERI DISC PACK, Medline kit SKU DYNJ66311C; 3) DISCECTOMY PACK, Medline kit SKU DYNJ86770; 4) TOTAL KNEE, Medline kit SKU DYNJ909643F.
Medline kits contain B. Braun IV Administration Sets and Pump Administration Sets which were recalled due to customer complaints identifying that the check valve components may become stuck in the open or closed positions.
FDA DevicesIvenix Infusion System (IIS), LVP Software: LVP-SW-0005.
Ivenix Infusion System (IIS), LVP Software: LVP-SW-0005.
Emphasizing instructions for LVP duration programming located in the IFU.
FDA DrugsLUCKY ICE, Cool Mouthwash, Alcohol Free, 16.9oz, 12CT, UPC: 808829108989
LUCKY ICE, Cool Mouthwash, Alcohol Free, 16.9oz, 12CT, UPC: 808829108989
CGMP Deviations: Insanitary conditions including rodent exposure/activity in their distribution center.
UKClass 2 Medicines Recall: Mercury Pharmaceuticals Ltd, Paliperidone Mercury Pharma prolonged-release suspension for injection in pre-filled syringes, EL(26)A/01
Class 2 Medicines Recall: Mercury Pharmaceuticals Ltd, Paliperidone Mercury Pharma prolonged-release suspension for injection in pre-filled syringes, EL(26)A/01
Mercury Pharmaceuticals Ltd is recalling remaining stock of paliperidone pre-filled syringes as a precautionary measure due to Good Manufacturing Practice (GMP) deficiencies cited during a recent insp...
Health CanadaPrismaflex Control Units
Prismaflex Control Units
Performance
Health CanadaOmni Legend
Omni Legend
Performance
Health CanadaHickman™ and Broviac™ Central Venous Catheter Kits
Hickman™ and Broviac™ Central Venous Catheter Kits
Sterility
Health CanadaLeft Coast Organics brand Organic Chia Seeds recalled due to Salmonella
Left Coast Organics brand Organic Chia Seeds recalled due to Salmonella
Salmonella
Health CanadaDisney Baby Water Teethers recalled due to microbial contamination
Disney Baby Water Teethers recalled due to microbial contamination
Microbial hazard
Health CanadaTransport Canada Recall - 2026007 - MOTOR COACH INDUSTRIES
Transport Canada Recall - 2026007 - MOTOR COACH INDUSTRIES
Visual System
Health CanadaTransport Canada Recall - 2026010 - FOREST RIVER
Transport Canada Recall - 2026010 - FOREST RIVER
Electrical
Health CanadaTransport Canada Recall - 2025485 - VOLVO
Transport Canada Recall - 2025485 - VOLVO
Visual System
Health CanadaVEVOR Garment Steamer recalled due to burn hazard
VEVOR Garment Steamer recalled due to burn hazard
Burn hazard
Health CanadaMuc-Off, Disc Brake Cleaner recalled due to excessively high flammability
Muc-Off, Disc Brake Cleaner recalled due to excessively high flammability
Flammability hazard