Estados Unidos Recalls
Retiros de seguridad del consumidor de la FDA, CPSC, NHTSA y USDA FSIS.
CPSCNatural Pigments Recalls Rublev Colours Gum Turpentine and Mineral Spirits Bottles Due to Risk of Serious Injury or Death from Child Poisoning; Violates Mandatory Standard for Child-Resistant Packaging
Natural Pigments Recalls Rublev Colours Gum Turpentine and Mineral Spirits Bottles Due to Risk of Serious Injury or Death from Child Poisoning; Violates Mandatory Standard for Child-Resistant Packaging
The gum turpentine and mineral spirits contain turpentine and low-viscosity hydrocarbons, respectively, which must be in child-resistant packaging, as required by the Poison Prevention Packaging Act. The bottles are not child-resistant, posing a risk of serious injury or death from poisoning if the contents are swallowed by young children.
CPSCZMC Group Recalls Multiple Light Up Toys Due to Risk of Serious Injury or Death from Battery Ingestion; Violate Mandatory Standard for Toys
ZMC Group Recalls Multiple Light Up Toys Due to Risk of Serious Injury or Death from Battery Ingestion; Violate Mandatory Standard for Toys
The recalled toys violate the mandatory safety standard for children's toys because the toy contains button cell batteries that can be easily accessed by children. If button cell or coin batteries are swallowed, the ingested batteries can cause serious injuries, including internal chemical burns, and death.
CPSCAnalemma Water Bottles Recalled Due to Risk of Serious Injury or Death from Laceration and Ingestion Hazards; Imported by New Earth Technologies d.o.o.
Analemma Water Bottles Recalled Due to Risk of Serious Injury or Death from Laceration and Ingestion Hazards; Imported by New Earth Technologies d.o.o.
The recalled water bottle's inner glass liner can break, posing a risk of serious injury or death from laceration and ingestion hazards.
CPSCEVLWZL and Gunugu Mattresses Recalled Due to Risk of Serious Injury or Death from Fire Hazard; Violates Mandatory Standard for Mattress Flammability
EVLWZL and Gunugu Mattresses Recalled Due to Risk of Serious Injury or Death from Fire Hazard; Violates Mandatory Standard for Mattress Flammability
The mattresses violate the mandatory flammability standard for mattresses, posing a risk of serious injury or death from fire.
NHTSAChrysler (FCA US, LLC) - Power Transfer Unit May Fail and Cause a Loss of Drive Power
Chrysler (FCA US, LLC) - Power Transfer Unit May Fail and Cause a Loss of Drive Power
A failed PTU may result in a loss of drive power or vehicle rollaway, increasing the risk of a crash or injury.
CPSCSvnntaa Bed Rails Recalled Due to Risk of Serious Injury or Death from Entrapment and Asphyxiation Hazards; Violates Mandatory Standard for Adult Portable Bed Rails; Sold on Amazon by Eokeanon
Svnntaa Bed Rails Recalled Due to Risk of Serious Injury or Death from Entrapment and Asphyxiation Hazards; Violates Mandatory Standard for Adult Portable Bed Rails; Sold on Amazon by Eokeanon
The recalled bed rails violate the mandatory standard for adult portable bed rails because users can become entrapped within the bed rail or between the bed rail and the side of the mattress, posing a serious entrapment hazard and risk of death by asphyxiation. The bed rails do not meet structural stability or retention strap requirements, posing a fall hazard. Furthermore, the bed rails' push pins and push pin holes are incorrectly sized, posing a laceration hazard.
CPSCMulti-Purpose Helmets Recalled Due to Risk of Serious Injury or Death from Head Injury; Violates Mandatory Standard for Bicycle Helmets; Sold on Temu by Foubeaka and Geniuss
Multi-Purpose Helmets Recalled Due to Risk of Serious Injury or Death from Head Injury; Violates Mandatory Standard for Bicycle Helmets; Sold on Temu by Foubeaka and Geniuss
The recalled helmets violate the mandatory safety standard for bicycle helmets because the helmets do not comply with the positional stability and certification requirements. The helmets can fail to protect the user in the event of a crash, posing a serious risk of injury or death due to head injury.
CPSCEEMB USA Recalls Battery Pouches Due to Risk of Serious Injury or Death from Battery Ingestion; Violate Federal Statute for Child-Resistant Packaging of Coin Batteries
EEMB USA Recalls Battery Pouches Due to Risk of Serious Injury or Death from Battery Ingestion; Violate Federal Statute for Child-Resistant Packaging of Coin Batteries
The lithium coin batteries are in pouches that are not child-resistant as required under Reese's Law. If a child swallows button cell or coin batteries, the ingested batteries can cause serious injuries, including internal chemical burns and death.
NHTSAGeneral Motors, LLC - Do Not Drive: Front and/or Rear Wheels May Lock Up
General Motors, LLC - Do Not Drive: Front and/or Rear Wheels May Lock Up
Front or rear wheel lockup increases the risk of a crash.
NHTSAChrysler (FCA US, LLC) - Vehicle Can Exceed the Speed Rating of the Tires
Chrysler (FCA US, LLC) - Vehicle Can Exceed the Speed Rating of the Tires
Loss of vehicle control increases the risk of a crash.
FDA DevicesPhilips Bridge Prep Kit REF: K12-09098C Sterile EO, Rx ONLY
Philips Bridge Prep Kit REF: K12-09098C Sterile EO, Rx ONLY
catheter may experience resistance when being advanced over the guidewire
FDA DevicesBrand Name: Kiwi Omni Vacuum Delivery System Product Name: Kiwi Omni Vacuum Delivery System Model/Catalog Number: VAC-6000MT Product Description: The Clinical Innovations Kiwi is a disposable vacuum assisted fetal delivery system. It is a sterile, single-patient-use device designed to provide assistance in childbirth under the following conditions: 1) Term pregnancy, 2) Ruptured amniotic membranes, 3) Engaged head, 4) Complete cervical dilation, and 5) Adequately trained or supervised operator.
Brand Name: Kiwi Omni Vacuum Delivery System Product Name: Kiwi Omni Vacuum Delivery System Model/Catalog Number: VAC-6000MT Product Description: The Clinical Innovations Kiwi is a disposable vacuum assisted fetal delivery system. It is a sterile, single-patient-use device designed to provide assistance in childbirth under the following conditions: 1) Term pregnancy, 2) Ruptured amniotic membranes, 3) Engaged head, 4) Complete cervical dilation, and 5) Adequately trained or supervised operator.
Due to complaints of device breakage at the traction force gauge to handle joint.
FDA DevicesDepuy Synthes, ATTUNE REVISION HINGE FEMORAL RT SZ 5 CEM. Part Number: 150450205.
Depuy Synthes, ATTUNE REVISION HINGE FEMORAL RT SZ 5 CEM. Part Number: 150450205.
The external sterile packaging was found adhered to the internal sterile packaging, potentially compromising sterility.
FDA DevicesMedline medical procedure kits, containing Medline Neuro Sponges, labeled as follows: GENERAL KIT, Medline Kit Number/SKU DYNJ905664I
Medline medical procedure kits, containing Medline Neuro Sponges, labeled as follows: GENERAL KIT, Medline Kit Number/SKU DYNJ905664I
During an internal review, Medline identified higher-than-expected endotoxin levels on a representative Medline neuro sponge product, indicating that in-market product may be out-of-specification for endotoxin.
FDA DevicesiLet Bionic Pancreas, REF: BB1001
iLet Bionic Pancreas, REF: BB1001
insulin pump software versions 1.4.2, and 1.4.3 issue with Dexcom Continuous Glucose Monitoring (CGM) G7 sensor may result in delayed CGM reading then switch to non-CGM dosing, leading to only basal/requested meal doses provided, no correction doses/insulin reductions/suspensions for high/low glucose unless blood glucose entered for sensor life or replacement. Potential health risks to users include severe hyperglycemia with and without DKA and severe hypoglycemia.
FDA Food52USA brand POPPING BOBA; MANGO FLAVOR; Net wt: 7 lb (3.2kg); Ingredients Drinking water, fructose syrup, food additives (hydroxypropyl distarch phosphate (E1442), calcium lactate (E327), DL-malic acid (E296), sodium alginate (E401), citric acid (E330), carrageenan (EE407), potassium chloride (E508), potassium sorbate (E202), guar gum (E412), trisodium citrate (E331), beta-carotene (E160a). sucralose (E955), tartrazine (E102), sunset yellow (E110)), food flavors.; CONTAINS NO JUICE; Shelf Life: 18 months; Distributed for Felicific Inc., Queens, NY 11435; PRODUCT OF CHINA; UPC 8 1018 42124 4
52USA brand POPPING BOBA; MANGO FLAVOR; Net wt: 7 lb (3.2kg); Ingredients Drinking water, fructose syrup, food additives (hydroxypropyl distarch phosphate (E1442), calcium lactate (E327), DL-malic acid (E296), sodium alginate (E401), citric acid (E330), carrageenan (EE407), potassium chloride (E508), potassium sorbate (E202), guar gum (E412), trisodium citrate (E331), beta-carotene (E160a). sucralose (E955), tartrazine (E102), sunset yellow (E110)), food flavors.; CONTAINS NO JUICE; Shelf Life: 18 months; Distributed for Felicific Inc., Queens, NY 11435; PRODUCT OF CHINA; UPC 8 1018 42124 4
Products contain unapproved colors, specifically tartrazine (FD&C Yellow 5), sunset yellow (FD&C Yellow 6), and allura red (FD&C Red 40).
FDA DevicesCenturion medical convenience kits, containing Webcol Large Alcohol Prep Pads, labeled as: Universal Central/Art Line Insertion Kit, Medline Kit SKU ART155A
Centurion medical convenience kits, containing Webcol Large Alcohol Prep Pads, labeled as: Universal Central/Art Line Insertion Kit, Medline Kit SKU ART155A
Medline Industries, LP is issuing a recall for specific item(s) and lot(s) of Medline Kits containing Cardinal Health Webcol Large Alcohol Prep Pads. Cardinal Health has deemed Webcol Large Alcohol Prep Pads to be non-sterile following the discovery of a contaminant (Paenibacillus phoenicis) during a routine sterilization dose audit.
FDA DevicesCenturion medical procedure kits, containing Medline Neuro Sponges, labeled as follows: SURGICAL ENT PREP KIT, Medline Kit Number/SKU MNS11715
Centurion medical procedure kits, containing Medline Neuro Sponges, labeled as follows: SURGICAL ENT PREP KIT, Medline Kit Number/SKU MNS11715
During an internal review, Medline identified higher-than-expected endotoxin levels on a representative Medline neuro sponge product, indicating that in-market product may be out-of-specification for endotoxin.
FDA DevicesMedline medical procedure kits, containing Medline Neuro Sponges, labeled as follows: 1. OSC COLEMAN FAT HARVEST KIT, Medline Kit Number/SKU DYNJ32854B; 2. RR-DR. CHHETRI MDL PACK, Medline Kit Number/SKU DYNJ62635B.
Medline medical procedure kits, containing Medline Neuro Sponges, labeled as follows: 1. OSC COLEMAN FAT HARVEST KIT, Medline Kit Number/SKU DYNJ32854B; 2. RR-DR. CHHETRI MDL PACK, Medline Kit Number/SKU DYNJ62635B.
During an internal review, Medline identified higher-than-expected endotoxin levels on a representative Medline neuro sponge product, indicating that in-market product may be out-of-specification for endotoxin.
FDA DevicesPhilips Ingenia Elition X with MR Elastography (MRE). 1. Model Number (REF): 781358. 2. Model Number (REF): 782107. 3. Model Number (REF): 782136. 510(k) Numbers: K213516, K223458, K230972, K232030, K251397, K251808
Philips Ingenia Elition X with MR Elastography (MRE). 1. Model Number (REF): 781358. 2. Model Number (REF): 782107. 3. Model Number (REF): 782136. 510(k) Numbers: K213516, K223458, K230972, K232030, K251397, K251808
The potential for stiffness value errors when a specific range of image reconstruction parameters is used in combination with Resoundant's algorithm, leading to the reconstruction voxel size settings in the default MRE scan protocol displaying too small.
FDA Devicesi-STAT EG6+ cartridge; List Number: 03P77-25;
i-STAT EG6+ cartridge; List Number: 03P77-25;
Approximately 7.6% of cartridges from specific i-STAT EG7+ (list number 03P76-25), i-STAT EG6+ (list number 03P77-25) and i-STAT G3+ (list number 03P78-26) cartridge lots in the U.S. marketplace may report higher than expected PCO2 and lower than expected pH results due to a manufacturing issue. A falsely high pCO2 together with a falsely low pH makes the blood gas appear as if the patient is in severe respiratory acidosis. If the clinician believes the values are real, it may trigger unnecessary or even harmful interventions such as unnecessary ventilator changes, unnecessary medications, potential harm from overcorrection, or delays in identifying true problems.
FDA DevicesPhilips Achieva 3.0T with MR Elastography (MRE). 1. Model Number (REF): 781278.
Philips Achieva 3.0T with MR Elastography (MRE). 1. Model Number (REF): 781278.
The potential for stiffness value errors when a specific range of image reconstruction parameters is used in combination with Resoundant's algorithm, leading to the reconstruction voxel size settings in the default MRE scan protocol displaying too small.
FDA DevicesBD GasPak EZ CO2 Pouch System. Catalog Number: 260684. for microbiologic use
BD GasPak EZ CO2 Pouch System. Catalog Number: 260684. for microbiologic use
BD identified an issue affecting certain lots of BD GasPak EZ CO2 and BD GasPak EZ Campy Gas Generating Pouch Systems, where gas generating sachets may produce carbon dioxide levels below specification.
FDA DevicesMedline medical procedure kits, containing Medline Neuro Sponges, labeled as follows: EH BRONCHOSCOPY, Medline Kit Number/SKU DYNJT3270
Medline medical procedure kits, containing Medline Neuro Sponges, labeled as follows: EH BRONCHOSCOPY, Medline Kit Number/SKU DYNJT3270
During an internal review, Medline identified higher-than-expected endotoxin levels on a representative Medline neuro sponge product, indicating that in-market product may be out-of-specification for endotoxin.