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Found 12,723 results for "product recalls and alerts"
FDA DevicesBrand Name: EDAN Product Name: Vital Signs Monitor Model/Catalog Number: iM3s, iM3As, iM3Bs, iHM3s Product Description: The iM3s series vital signs monitors including iM3s/iM3As/iM3Bs/iHM3s are intended to be used for measuring, storing, reviewing of, and generating prompts for multiple physiological parameters of adults and pediatrics. Component: No
Brand Name: EDAN Product Name: Vital Signs Monitor Model/Catalog Number: iM3s, iM3As, iM3Bs, iHM3s Product Description: The iM3s series vital signs monitors including iM3s/iM3As/iM3Bs/iHM3s are intended to be used for measuring, storing, reviewing of, and generating prompts for multiple physiological parameters of adults and pediatrics. Component: No
As a result of receiving an FDA It Has Come to Our Attention Letter (IHCTOA Letter) regarding potential cybersecurity issues with various of the firm device.
FDA DevicesBrand Name: MicroPort Product Name: HIPTURN FEM HEAD TRIAL 36MM REUSABLE Model/Catalog Number: HTHT0036 Software Version: N/A Product Description: HIPTURN FEM HEAD TRIAL 36MM REUSABLE
Brand Name: MicroPort Product Name: HIPTURN FEM HEAD TRIAL 36MM REUSABLE Model/Catalog Number: HTHT0036 Software Version: N/A Product Description: HIPTURN FEM HEAD TRIAL 36MM REUSABLE
Due to products not having FDA Premarket authorization to be distributed within the United States.
FDA DevicesBrand Name: RayStation Product Name: RayStation/RayPlan Model/Catalog Number: 15.2.0, 15.1.3 Software Version: RayStation 2024A SP1, RayStation 2024A SP2 Product Description: Radiation Therapy Treatment Planning System Component: No
Brand Name: RayStation Product Name: RayStation/RayPlan Model/Catalog Number: 15.2.0, 15.1.3 Software Version: RayStation 2024A SP1, RayStation 2024A SP2 Product Description: Radiation Therapy Treatment Planning System Component: No
Potential for the invalidation for calculated radiation dose does not work as intended for certain Regions of Interest (ROIs). This issue occurs for some ROI(s) which have no contours and either have a material override defined, or are of type Bolus, Fixation, or Support. In these cases, adding geometry to the ROI, subsequently modifying geometry, or removing the material override does not invalidate dose as intended.
FDA DevicesBrand Name: EDAN Product Name: Vital Signs Monitor Model/Catalog Number: iM3 Product Description: The iM3 has three work modes, Monitor, Spot and Round, to measure physiological parameters, including non-invasive blood pressure (NIBP), oxygen saturation of the blood (SpO2), pulse rate (PR), and Quick TEMP/Infrared TEMP (TEMP). iM3 capabilities include storing, displaying measuring data. When necessary, alarms will be produced so that doctors and nurses can manage patient care appropriately. Component: No
Brand Name: EDAN Product Name: Vital Signs Monitor Model/Catalog Number: iM3 Product Description: The iM3 has three work modes, Monitor, Spot and Round, to measure physiological parameters, including non-invasive blood pressure (NIBP), oxygen saturation of the blood (SpO2), pulse rate (PR), and Quick TEMP/Infrared TEMP (TEMP). iM3 capabilities include storing, displaying measuring data. When necessary, alarms will be produced so that doctors and nurses can manage patient care appropriately. Component: No
As a result of receiving an FDA It Has Come to Our Attention Letter (IHCTOA Letter) regarding potential cybersecurity issues with various of the firm device.
Health CanadaRoller and Duo Blinds by Interiors by Better Shade recalled due to a strangulation hazard
Roller and Duo Blinds by Interiors by Better Shade recalled due to a strangulation hazard
Strangulation hazard
FDA DevicesThe LDL-Cholesterol assay is comprised of two distinct phases. In phase one a unique detergent solubilizes cholesterol from non-LDL- lipoprotein particles. This cholesterol is consumed by cholesterol esterase, cholesterol oxidase, peroxidase and 4- aminoantipyrine to generate a colorless end product. In phase two a second detergent in reagent 2 releases cholesterol from the LDL lipoproteins. This cholesterol reacts with cholesterol esterase, cholesterol oxidase and a chromogen system to yield a blue color complex which can be measured bichromatically at 540/660nm. The resulting increase in absorbance is directly proportional to the LDL-C concentration in the sample.
The LDL-Cholesterol assay is comprised of two distinct phases. In phase one a unique detergent solubilizes cholesterol from non-LDL- lipoprotein particles. This cholesterol is consumed by cholesterol esterase, cholesterol oxidase, peroxidase and 4- aminoantipyrine to generate a colorless end product. In phase two a second detergent in reagent 2 releases cholesterol from the LDL lipoproteins. This cholesterol reacts with cholesterol esterase, cholesterol oxidase and a chromogen system to yield a blue color complex which can be measured bichromatically at 540/660nm. The resulting increase in absorbance is directly proportional to the LDL-C concentration in the sample.
Beckman Coulter identified that LDL Cholesterol OSR6x96 is not meeting the performance claim listed in the Instructions for Use (IFU). LDL Cholesterol reagent showed clinically significant interference due to triglyceride concentration up to 1500 mg/dL may cause a maximum positive bias of up to 28.8% in low LDL Cholesterol samples (concentration 80 mg/dL) and up to 11.02% in high LDL Cholesterol samples (concentration 160mg/dL).
FDA DevicesBrand Name: RayStation Product Name: RayStation/RayPlan Model/Catalog Number: 10.1.1 Software Version: RayStation 10B SP1 Product Description: Radiation Therapy Treatment Planning System Component: No
Brand Name: RayStation Product Name: RayStation/RayPlan Model/Catalog Number: 10.1.1 Software Version: RayStation 10B SP1 Product Description: Radiation Therapy Treatment Planning System Component: No
Potential for the invalidation for calculated radiation dose does not work as intended for certain Regions of Interest (ROIs). This issue occurs for some ROI(s) which have no contours and either have a material override defined, or are of type Bolus, Fixation, or Support. In these cases, adding geometry to the ROI, subsequently modifying geometry, or removing the material override does not invalidate dose as intended.
UKClass 4 Medicines Defect Notification: Viatris Products Ltd, Arixtra solution for injection, pre-filled syringes, EL(26)A/04
Class 4 Medicines Defect Notification: Viatris Products Ltd, Arixtra solution for injection, pre-filled syringes, EL(26)A/04
Viatris has received reports of brown discolouration and blockage in the needle of pre-filled syringes of Arixtra. This quality defect is related to oxidation of the syringe needle....
FDA DevicesBrand Name: EDAN Product Name: Patient Monitor Model/Catalog Number: iX10, iX12, iX15 Product Description: The iX series Patient Monitors including iX10, iX12, iX15 can perform long-time continuous monitoring of multiple physiological parameters. Also, it is capable of storing, displaying, analyzing and controlling measurements, and it will indicate alarms in case of abnormalities so that doctors and nurses can respond to the patient's situation as appropriate. Component: No
Brand Name: EDAN Product Name: Patient Monitor Model/Catalog Number: iX10, iX12, iX15 Product Description: The iX series Patient Monitors including iX10, iX12, iX15 can perform long-time continuous monitoring of multiple physiological parameters. Also, it is capable of storing, displaying, analyzing and controlling measurements, and it will indicate alarms in case of abnormalities so that doctors and nurses can respond to the patient's situation as appropriate. Component: No
As a result of receiving an FDA It Has Come to Our Attention Letter (IHCTOA Letter) regarding potential cybersecurity issues with various of the firm device.
Health CanadaRoller Shade by Starlight Shutter recalled due to strangulation hazard for children
Roller Shade by Starlight Shutter recalled due to strangulation hazard for children
Strangulation hazard
CPSCAborder Products Recalls Cumbor Retractable Safety Gates Due to Risk of Serious Injury or Death to Children from Entrapment; Violates Mandatory Standard for Gates and Enclosures
Aborder Products Recalls Cumbor Retractable Safety Gates Due to Risk of Serious Injury or Death to Children from Entrapment; Violates Mandatory Standard for Gates and Enclosures
The recalled gates violate the mandatory standard for expansion gates and expandable enclosures because a child's torso can fit through the opening between the gate and the floor, posing a risk of serious injury or death due to entrapment.
Health CanadaAngry Orange Stain Removers recalled due to risk of exposure to bacteria
Angry Orange Stain Removers recalled due to risk of exposure to bacteria
Microbial hazard
FDA FoodUkrop's 6" Pound Cake with Buttercream Icing/Red Roses NET WT 30 OZ (2.06lb/936g) UPC 7 22515 91452 7 and Ukrop's 8" Pound Cake with Buttercream Icing/Red Roses NET WT 44 OZ (2.75lb/1.25kg) UPC 7 22515 91456 5 CONTAINS: Egg, Milk, Wheat Made in a production area that also uses soy and tree nuts. Ukrop's Homestyle Foods, LLC Richmond, VA 23230
Ukrop's 6" Pound Cake with Buttercream Icing/Red Roses NET WT 30 OZ (2.06lb/936g) UPC 7 22515 91452 7 and Ukrop's 8" Pound Cake with Buttercream Icing/Red Roses NET WT 44 OZ (2.75lb/1.25kg) UPC 7 22515 91456 5 CONTAINS: Egg, Milk, Wheat Made in a production area that also uses soy and tree nuts. Ukrop's Homestyle Foods, LLC Richmond, VA 23230
Undeclared Soy. Label did not include soy, which was used in product.
FDA DevicesBrand Name: PALACOS Product Name: PALACOS R pro 40; PALACOS R pro 80 Model/Catalog Number: 5081286; 5081287 Software Version: N/A Product Description: Radiopaque, poly(methyl methacrylate)-based (PMMA) bone cement, pre-filled into a mixing and application system, suitable for use with or without vacuum (ready to mix). Component: N/A
Brand Name: PALACOS Product Name: PALACOS R pro 40; PALACOS R pro 80 Model/Catalog Number: 5081286; 5081287 Software Version: N/A Product Description: Radiopaque, poly(methyl methacrylate)-based (PMMA) bone cement, pre-filled into a mixing and application system, suitable for use with or without vacuum (ready to mix). Component: N/A
increase of complaints regarding the breakage of the ampoules within their device systems. An extensive investigation revealed that multiple factors have an impact on the ampoule breakage. An unfortunate combination of these influence factors can lead to unbreakable ampoules. If none or not all ampoules break, the product cannot be used on the patient since no or no appropriate cement dough is formed.
Health CanadaNûby IcyBite™ Keys Teethers recalled due to microbial contamination
Nûby IcyBite™ Keys Teethers recalled due to microbial contamination
Microbial hazard
FDA FoodSo Delicious Dairy Free Salted Caramel Cluster Cashewmilk, Non-Dairy Frozen Dessert, One Pint (473 mL). UPC 744473 476138. Manufactured By/For So Delicious Dairy Free Eugene, OR 97402 So Delicious Dairy Free Salted Caramel Cluster Cashewmilk, Non-Dairy Frozen Dessert. Net wt. 500mL. UPC 744473 276134. Product of the U.S.A. Distributed by Danone Inc., Boucherville, Quebec J4B 1E6
So Delicious Dairy Free Salted Caramel Cluster Cashewmilk, Non-Dairy Frozen Dessert, One Pint (473 mL). UPC 744473 476138. Manufactured By/For So Delicious Dairy Free Eugene, OR 97402 So Delicious Dairy Free Salted Caramel Cluster Cashewmilk, Non-Dairy Frozen Dessert. Net wt. 500mL. UPC 744473 276134. Product of the U.S.A. Distributed by Danone Inc., Boucherville, Quebec J4B 1E6
Foreign material
FDA DrugsAQ 120 GFEW, Aquarion Preserved Cartridges (2) 3.7 Gallons each
AQ 120 GFEW, Aquarion Preserved Cartridges (2) 3.7 Gallons each
cGMP deviations.
FDA FoodTops Mixed Fruit Jam INGREDIENTS: Sugar, Mixed Fruit Pulp 48% (Apple, Pear, Guava, Pineapple, Banana, Mango, Grapes, Papaya), Gelling Agent (Pectin - INS 440), Acidity Regulator (Citric Acid - INS 330), Preservative (Sodium Benzoate - INS 211, Potassium metabisulphite - INS 224), Food Colour (Carmoisine - INS 122), Nature Identical Flavouring Substances (Apple & Pineapple) & Artificial Flavouring Substances (Banana, Raspberry & Strawberry). Allergen Advice: Contains Sulphite, May Contain Soy & Wheat. PRODUCT OF INDIA Brand Owned & Mktd. by: G.D. Foods Mfg. (I) Pvt. Ltd. C-1/119, Janak Puri, New Delhi - 110058 (INDIA) Mfd. by: G.D. Foods Mfg. (I) Pvt. Ltd. Plot No. SP-15&16. RIICO Industrial Area, Neemrana-301705, Dist. - Kotputli-Behror, Rajasthan (INDIA) Imported and Distributed by: Mangalm LLC California, USA Email: info@mangalm.com Phone: 925-302-6025 UPC: 8 904288 626025 Batch No.: 4F1101 Best Before: 10.06.26 NET QTY.: 16.75 oz (475g)
Tops Mixed Fruit Jam INGREDIENTS: Sugar, Mixed Fruit Pulp 48% (Apple, Pear, Guava, Pineapple, Banana, Mango, Grapes, Papaya), Gelling Agent (Pectin - INS 440), Acidity Regulator (Citric Acid - INS 330), Preservative (Sodium Benzoate - INS 211, Potassium metabisulphite - INS 224), Food Colour (Carmoisine - INS 122), Nature Identical Flavouring Substances (Apple & Pineapple) & Artificial Flavouring Substances (Banana, Raspberry & Strawberry). Allergen Advice: Contains Sulphite, May Contain Soy & Wheat. PRODUCT OF INDIA Brand Owned & Mktd. by: G.D. Foods Mfg. (I) Pvt. Ltd. C-1/119, Janak Puri, New Delhi - 110058 (INDIA) Mfd. by: G.D. Foods Mfg. (I) Pvt. Ltd. Plot No. SP-15&16. RIICO Industrial Area, Neemrana-301705, Dist. - Kotputli-Behror, Rajasthan (INDIA) Imported and Distributed by: Mangalm LLC California, USA Email: info@mangalm.com Phone: 925-302-6025 UPC: 8 904288 626025 Batch No.: 4F1101 Best Before: 10.06.26 NET QTY.: 16.75 oz (475g)
Unapproved color (carmoisine).
FDA DevicesProduct Name: Allura Xper FD10C; Model number: 722001;
Product Name: Allura Xper FD10C; Model number: 722001;
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 FoodUkrop's 6" Pound Cake with Buttercream Icing/Confetti NET WT 30 OZ (1.88lb/851g) CONTAINS: Egg, Milk, Wheat Made in a production area that also uses soy and tree nuts. UPC 7 22515 91849 5 Ukrop's Homestyle Foods, LLC Richmond, VA 23
Ukrop's 6" Pound Cake with Buttercream Icing/Confetti NET WT 30 OZ (1.88lb/851g) CONTAINS: Egg, Milk, Wheat Made in a production area that also uses soy and tree nuts. UPC 7 22515 91849 5 Ukrop's Homestyle Foods, LLC Richmond, VA 23
Undeclared Soy. Label did not include soy, which was used in product.
FDA DevicesBrand Name: PALACOS Product Name: PALACOS MV pro 40; PALACOS MV pro 80 Model/Catalog Number: 5150633; 5150635 Software Version: N/A Product Description: Radiopaque, poly(methyl methacrylate)-based (PMMA) bone cement, pre-filled into a mixing and application system, suitable for use with or without vacuum (ready to mix). Component: N/A
Brand Name: PALACOS Product Name: PALACOS MV pro 40; PALACOS MV pro 80 Model/Catalog Number: 5150633; 5150635 Software Version: N/A Product Description: Radiopaque, poly(methyl methacrylate)-based (PMMA) bone cement, pre-filled into a mixing and application system, suitable for use with or without vacuum (ready to mix). Component: N/A
increase of complaints regarding the breakage of the ampoules within their device systems. An extensive investigation revealed that multiple factors have an impact on the ampoule breakage. An unfortunate combination of these influence factors can lead to unbreakable ampoules. If none or not all ampoules break, the product cannot be used on the patient since no or no appropriate cement dough is formed.
Health CanadaPNW Components Loam Pedal Gen 2 bicycle pedals recalled due to fall hazard
PNW Components Loam Pedal Gen 2 bicycle pedals recalled due to fall hazard
Fall hazard
Health CanadaANNQUAN Brand Power Strips recalled due to fire hazard
ANNQUAN Brand Power Strips recalled due to fire hazard
Fire hazard
FDA DevicesBrand Name: PALACOS Product Name: PALACOS R+G pro 40; PALACOS R+G pro 80 Model/Catalog Number: 5081288; 5081289 Software Version: N/A Product Description: Radiopaque, poly(methyl methacrylate)-based (PMMA) bone cement, pre-filled into a mixing and application system, suitable for use with or without vacuum (ready to mix). Component: N/A
Brand Name: PALACOS Product Name: PALACOS R+G pro 40; PALACOS R+G pro 80 Model/Catalog Number: 5081288; 5081289 Software Version: N/A Product Description: Radiopaque, poly(methyl methacrylate)-based (PMMA) bone cement, pre-filled into a mixing and application system, suitable for use with or without vacuum (ready to mix). Component: N/A
increase of complaints regarding the breakage of the ampoules within their device systems. An extensive investigation revealed that multiple factors have an impact on the ampoule breakage. An unfortunate combination of these influence factors can lead to unbreakable ampoules. If none or not all ampoules break, the product cannot be used on the patient since no or no appropriate cement dough is formed.