Estados Unidos Recalls
Retiros de seguridad del consumidor de la FDA, CPSC, NHTSA y USDA FSIS.
CPSCIristar Minoxidil Spray Bottles for Hair and Beard Growth Recalled Due to Risk of Serious Injury or Death from Child Poisoning; Violates Mandatory Standard for Child-Resistant Packaging; Sold on Amazon by Moralowen
Iristar Minoxidil Spray Bottles for Hair and Beard Growth Recalled Due to Risk of Serious Injury or Death from Child Poisoning; Violates Mandatory Standard for Child-Resistant Packaging; Sold on Amazon by Moralowen
The recalled spray bottles contain minoxidil, which must be in child-resistant packaging, as required by the Poison Prevention Packaging Act. The packaging is not child-resistant, posing a risk of serious injury or death from poisoning if the contents are swallowed by young children.
CPSCGagaku Children's Ice Cream Toy Playsets Recalled Due to Risk of Serious Injury or Death from Magnet Ingestion Hazard; Violate Mandatory Standard for Toys; Sold on Amazon by Brandworl.USA
Gagaku Children's Ice Cream Toy Playsets Recalled Due to Risk of Serious Injury or Death from Magnet Ingestion Hazard; Violate Mandatory Standard for Toys; Sold on Amazon by Brandworl.USA
The recalled toys violate the mandatory standard for toys because they contain high-powered magnets which can loosen and detach, posing an ingestion hazard to children. When high-powered magnets are swallowed, the ingested magnets can attract each other, or other metal objects, and become lodged in the digestive system. This can result in perforations, twisting and/or blockage of the intestines, blood poisoning and death.
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.
CPSCYetonamr Pull String Teething Toys Recalled Due to Risk of Serious Injury or Death from Choking; Violate Mandatory Standard for Toys; Sold on Amazon by Longyanguiheng
Yetonamr Pull String Teething Toys Recalled Due to Risk of Serious Injury or Death from Choking; Violate Mandatory Standard for Toys; Sold on Amazon by Longyanguiheng
The recalled teething toys violate the mandatory standard for toys because the silicone strings are smaller than permitted. The silicone strings can reach the back of the throat and become lodged, posing a risk of respiratory distress, serious choking hazard and death.
CPSCThrasio Recalls Angry Orange Enzyme Stain Removers Due to Risk of Exposure to Bacteria
Thrasio Recalls Angry Orange Enzyme Stain Removers Due to Risk of Exposure to Bacteria
The recalled products can contain bacteria, including Pseudomonas aeruginosa, an environmental organism found widely in soil and water. People with weakened immune systems, external medical devices, or underlying lung conditions who are exposed to Pseudomonas aeruginosa face a risk of serious infection that may require medical treatment. The bacteria can enter the body if inhaled, through the eyes, or through a break in the skin. People with healthy immune systems are usually not affected by bacteria.
CPSCJohnson Health Tech Expands Recall to Include Matrix Retail and Vision Treadmills Due to Fire Hazard
Johnson Health Tech Expands Recall to Include Matrix Retail and Vision Treadmills Due to Fire Hazard
The power cord can become loose from the treadmill's power socket, posing a fire hazard.
CPSCAcademy Sports + Outdoors Recalls Magellan Odyssey Rocker Chairs Due to Injury and Fall Hazards
Academy Sports + Outdoors Recalls Magellan Odyssey Rocker Chairs Due to Injury and Fall Hazards
The recalled chairs' legs can break, posing injury and fall hazards to consumers.
CPSCMikario Trading Convertible Baby Gyms Recalled Due to Risk of Serious Injury or Death from Suffocation; Violate Mandatory Standard for Infant Support Cushions; Sold on TikTok Shop
Mikario Trading Convertible Baby Gyms Recalled Due to Risk of Serious Injury or Death from Suffocation; Violate Mandatory Standard for Infant Support Cushions; Sold on TikTok Shop
The recalled baby gyms violate the mandatory safety standard for infant support cushions because the floor mats can obstruct an infant's breathing, posing a serious risk of injury or deadly suffocation hazard.
CPSCTopkay Lighters Recalled Due to Risk of Serious Injury or Death from Fire and Burn Hazards; Violates Mandatory Standard for Multipurpose Lighters; Sold on Amazon by Xiyude
Topkay Lighters Recalled Due to Risk of Serious Injury or Death from Fire and Burn Hazards; Violates Mandatory Standard for Multipurpose Lighters; Sold on Amazon by Xiyude
The recalled lighters violate the mandatory standard for multipurpose lighters because they do not have the required child-resistant mechanisms, posing a risk of serious injury or death from fire and burn hazards.
NHTSABlue Bird Body Company - Illegible DOT Marking on Window/FMVSS 205
Blue Bird Body Company - Illegible DOT Marking on Window/FMVSS 205
A missing DOT code mark may result in the window being replaced with an incorrect type of glass, increasing the risk of a injury.
NHTSAGeneral Motors, LLC - Damaged Parking Brake Wiring Harness
General Motors, LLC - Damaged Parking Brake Wiring Harness
Unintended activation of the parking brake while driving increases the risk of a crash. Loss of the parking brake function while parked can result in a rollaway, increasing the risk of a crash.
NHTSABlue Bird Body Company - Illegible DOT Marking on Window/FMVSS 205
Blue Bird Body Company - Illegible DOT Marking on Window/FMVSS 205
A missing DOT code mark may result in the window being replaced with an incorrect type of glass, increasing the risk of a injury.
CPSCBased Online Fidget Magnet Ball Toys Recalled Due to Risk of Serious Injury or Death from Magnet Ingestion; Violate Mandatory Standard for Toys
Based Online Fidget Magnet Ball Toys Recalled Due to Risk of Serious Injury or Death from Magnet Ingestion; Violate Mandatory Standard for Toys
The magnet ball toys violate the mandatory standard for toys because they are loose high-powered magnets, posing an ingestion hazard to children. When high-powered magnets are swallowed, they can attract each other, or other metal objects, and become lodged in the digestive system. This can result in perforations, twisting, and/or blockage of the intestines, blood poisoning and death.
FDA DevicesAllura Xper FD20; Model Number: 722028;
Allura Xper FD20; Model Number: 722028;
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 DrugsClindamycin Phosphate USP, 1% (10 mg/mL), Topical Solution, 60 mL per applicator bottle, Rx only, Mfd. by: Taro Pharmaceutical Industries Ltd., Haifa Bay, Israel; Dist. by: Taro Pharmaceuticals USA, Inc., Hawthorne, NY 10532, NDC# 51672-4081-4
Clindamycin Phosphate USP, 1% (10 mg/mL), Topical Solution, 60 mL per applicator bottle, Rx only, Mfd. by: Taro Pharmaceutical Industries Ltd., Haifa Bay, Israel; Dist. by: Taro Pharmaceuticals USA, Inc., Hawthorne, NY 10532, NDC# 51672-4081-4
Failed Impurities/Degradation: Out of Specification results for Total Impurities and for Assay.
FDA DrugsAlka Seltzer, a) Original, 2 tablets per packet in 58 count box, UPC: 815556020033, 016500514473, b) Plus Cold & Flu, 2 tablets per packet in 36 count box, UPC: 016500594932
Alka Seltzer, a) Original, 2 tablets per packet in 58 count box, UPC: 815556020033, 016500514473, b) Plus Cold & Flu, 2 tablets per packet in 36 count box, UPC: 016500594932
CGMP Deviations: Insanitary conditions including rodent exposure/activity in their distribution center.
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.
FDA FoodCinnamon, Clear Plastic Container, 100G, UPC 6251136 034139
Cinnamon, Clear Plastic Container, 100G, UPC 6251136 034139
Elevated levels of lead.
FDA DevicesMedline medical procedure convenience kits labeled as: 1) LAVH PROCEDURE, REF CDS980754T; 2) GYN LAP HYSTERECTOMY CDS, REF CDS982662Q; 3) DAVINCI HYSTERECTOMY CDS, REF CDS985344F; 4) LAVH, REF DYNJQ9041R; 5) LAPAROSCOPIC HYSTERECTOMY, REF DYNJ900244I; 6) ROBOTIC LAVH, REF DYNJ901281I; 7) LAVH-LF, REF DYNJ901829T; 8) LEX LAP HYST, REF DYNJ902030J; 9) LITHOTOMY-SLINGS-LF, REF DYNJ905274D; 10) GYN LAPAROSCOPY, REF DYNJ905485J; 11) ROBOTIC HYSTERECTOMY, REF DYNJ906380C; 12) LAPAROSCOPIC HYSTERECTOMY, REF DYNJ910634; 13) LAVH GYN/ONC, REF DYNJ910927.
Medline medical procedure convenience kits labeled as: 1) LAVH PROCEDURE, REF CDS980754T; 2) GYN LAP HYSTERECTOMY CDS, REF CDS982662Q; 3) DAVINCI HYSTERECTOMY CDS, REF CDS985344F; 4) LAVH, REF DYNJQ9041R; 5) LAPAROSCOPIC HYSTERECTOMY, REF DYNJ900244I; 6) ROBOTIC LAVH, REF DYNJ901281I; 7) LAVH-LF, REF DYNJ901829T; 8) LEX LAP HYST, REF DYNJ902030J; 9) LITHOTOMY-SLINGS-LF, REF DYNJ905274D; 10) GYN LAPAROSCOPY, REF DYNJ905485J; 11) ROBOTIC HYSTERECTOMY, REF DYNJ906380C; 12) LAPAROSCOPIC HYSTERECTOMY, REF DYNJ910634; 13) LAVH GYN/ONC, REF DYNJ910927.
Medline kits containing Stryker's Strykeflow 2 Suction Irrigators due to a change in design in 2024, irrigation solution is able to travel to the handpiece and battery pack during use of the Strykeflow 2 Suction Irrigator. This design change has caused some devices to leak and/or emit vaporized saline (which can resemble smoke) during use.
FDA DevicesPortex Spinal Tray, Item No. A3729-24 A3595
Portex Spinal Tray, Item No. A3729-24 A3595
Affected lots of syringes may have a crack on the syringe collar, which may lead to delayed or repeated blood draw/fluid delivery. This issue may also lead to blood leakage during sampling of arterial blood or leakage during fluid delivery.
FDA DevicesVANTAGE TITAN 3T Model MRT-3010/MEXL-3010
VANTAGE TITAN 3T Model MRT-3010/MEXL-3010
There is a potential for formation of ice occurring in the venting system of the superconducting magnet of the MRI systems. if a quench occurs in this condition, helium gas may not be able to escape via the designed vent paths, and the pressure in the helium vessel may rise. This pressure build-up could eventually rupture the helium vessel, causing helium gas to be released into the MR scanning room.
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.
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 DevicesDetachable 10in Pend FRU-1 Pend component for the AIRO Computed Tomography (CT) X-ray System.
Detachable 10in Pend FRU-1 Pend component for the AIRO Computed Tomography (CT) X-ray System.
AIRO pendant replacement kits and upgrade do not possess the "Safe Hand Position Warning" label.