États-Unis Recalls
Rappels de sécurité de la FDA, CPSC, NHTSA et de l’USDA FSIS.
CPSCMagnetic Stick Figure Sets Recalled Due to Risk of Serious Injury or Death from Magnet Ingestion; Violate Mandatory Standard for Toys; Sold on Walmart by BlissfulDestiny
Magnetic Stick Figure Sets Recalled Due to Risk of Serious Injury or Death from Magnet Ingestion; Violate Mandatory Standard for Toys; Sold on Walmart by BlissfulDestiny
The magnetic stick figures violate the mandatory standard for toys because they contain loose magnets 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.
CPSCWiifo Children's Tower Stools Recalled Due to Risk of Serious Injury and Death from Entrapment and Fall Hazards; Imported by Wiifo
Wiifo Children's Tower Stools Recalled Due to Risk of Serious Injury and Death from Entrapment and Fall Hazards; Imported by Wiifo
The recalled tower stools can collapse or tip over while in use, and a child's torso can fit through the openings on the tower's sides, posing a risk of serious injury and death due to tip over, fall and entrapment hazards.
CPSCAutobrush Recalls Sonic Pro Children's Toothbrush Boxes Due to Risk of Serious Injury or Death from Battery Ingestion; Violates Mandatory Standard for Consumer Products with Coin Batteries
Autobrush Recalls Sonic Pro Children's Toothbrush Boxes Due to Risk of Serious Injury or Death from Battery Ingestion; Violates Mandatory Standard for Consumer Products with Coin Batteries
The recalled delivery boxes violate the mandatory standard for consumer products containing button cell and coin batteries because they contain a lithium coin battery that can be easily accessed by children, posing an ingestion hazard. The packaging also does not bear the required warning labels for products containing such batteries as required by Reese's Law. If button cell or coin batteries are swallowed, the ingested batteries can cause serious injuries, including internal chemical burns, and death.
CPSCmGanna Sodium Hydroxide Pellet Bags Recalled Due to Risk of Serious Injury or Death from Chemical Burns and Irritation to the Skin and Eyes; Violate Mandatory Standard for Child-Resistant Packaging; Sold on Amazon by Archie Xpress
mGanna Sodium Hydroxide Pellet Bags Recalled Due to Risk of Serious Injury or Death from Chemical Burns and Irritation to the Skin and Eyes; Violate Mandatory Standard for Child-Resistant Packaging; Sold on Amazon by Archie Xpress
The recalled products contain sodium hydroxide (lye), which must be in child-resistant packaging as required by the Poison Prevention Packaging Act (PPPA). The packaging is not child-resistant, posing a risk of chemical burns and irritation to the skin and eyes. The products also violate the labeling requirements for hazardous substances under the Federal Hazardous Substances Act (FHSA).
NHTSAJaguar Land Rover North America, LLC - Fuel Tank May Leak
Jaguar Land Rover North America, LLC - Fuel Tank May Leak
In the event of a crash, an improperly manufactured fuel tank may leak fuel, increasing the risk of a fire.
CPSC32 Degrees Recalls Heated Socks Due to Burn Hazard
32 Degrees Recalls Heated Socks Due to Burn Hazard
When worn during high-intensity activities that generate a combination of heat, excessive friction, moisture and pressure, the socks can pose an injury hazard including burns.
CPSCChildren's Tower Stools Recalled Due to Risk of Serious Injury and Death from Entrapment and Fall Hazards; Imported by AMZCMJ DGD
Children's Tower Stools Recalled Due to Risk of Serious Injury and Death from Entrapment and Fall Hazards; Imported by AMZCMJ DGD
The recalled tower stools can collapse or tip over while in use and a child's torso can fit through the openings on the tower's sides, posing a risk of serious injury and death due to tip over, fall and entrapment hazards.
CPSCKMUYSL Big Red Barn Farm Animal Playsets Recalled Due to Risk of Serious Injury or Death from Choking; Violates Small Parts Ban; Sold on Amazon by MISSJUNE
KMUYSL Big Red Barn Farm Animal Playsets Recalled Due to Risk of Serious Injury or Death from Choking; Violates Small Parts Ban; Sold on Amazon by MISSJUNE
The recalled children's toys violate the small parts ban because the toy is intended for children under three years of age and the fence handles can detach from the toy, posing a deadly choking hazard.
CPSCHappyGira Recalls Sweetie Baby and Style Life Eleven Baby Loungers Due to Risk of Serious Injury or Death from Suffocation and Fall Hazards; Violates Mandatory Standard for Infant Sleep Products
HappyGira Recalls Sweetie Baby and Style Life Eleven Baby Loungers Due to Risk of Serious Injury or Death from Suffocation and Fall Hazards; Violates Mandatory Standard for Infant Sleep Products
The baby loungers violate the mandatory standard for infant sleep products because the sides are shorter than the minimum side height limit to secure the infant and they do not have a stand, posing a fall hazard. Additionally, an infant can fall out of the enclosed opening at the foot of the lounger or become entrapped. Furthermore, the sleeping pad's thickness exceeds the maximum limit, posing a suffocation hazard. These violations create an unsafe sleeping environment for infants, posing a risk of serious injury or death.
FDA DevicesiLet Ace Pump Kit REF: BB1001 iLet Dosing Decision Software
iLet Ace Pump Kit REF: BB1001 iLet Dosing Decision Software
it was found that in versions 1.3.7, 1.4.2, and 1.4.3, the Lock Screen and Limited Access Passcode Screen on the iLet graphical user interface (GUI) include certain icons displayed in the status bar that are active, thereby allowing the user to bypass those screens when those icons on the status bar are pressed, allowing unauthorized access while the device is in Limited Access Mode. A Health Risk associated with Limited access mode includes severe hypoglycemia due to unauthorized access to the iLet if someone were to make unauthorized meal announcements or stopped insulin delivery.
FDA DevicesB Braun Hemodialysis Bloodlines, LOW VOL, NO CHAMBER 4.8MM PUMP SEGMENT. Model Number: B3-4630M4705.
B Braun Hemodialysis Bloodlines, LOW VOL, NO CHAMBER 4.8MM PUMP SEGMENT. Model Number: B3-4630M4705.
Potential for the accumulation of small air bubbles in the arterial line due to adherence of blood gases to the tubing under negative pressure.
NHTSAWinnebago Industries, Inc. - Park Outside: Generator May Turn On Without Operator Action
Winnebago Industries, Inc. - Park Outside: Generator May Turn On Without Operator Action
People in an enclosed space, such as a garage, with a running generator may be at an increased risk of injury or death from carbon monoxide poisoning.
FDA FoodBooey's Dragon's Breath sauce, 15.2oz ringneck glass bottle. UPC on bottle: 7 01936 29222 3. There are 12 bottles per case. Manufactured Exclusively for BOOEYS GOURMET 3924 N. Cannon St. Spokane, WA 99205. Label declares: INGREDIENTS: Contains Soy and Wheat. *** Soy Sauce (Water, Soybeans, Wheat, Salt ***Squid Sauce (Anchovy Extract) ***Sesame Oil***.
Booey's Dragon's Breath sauce, 15.2oz ringneck glass bottle. UPC on bottle: 7 01936 29222 3. There are 12 bottles per case. Manufactured Exclusively for BOOEYS GOURMET 3924 N. Cannon St. Spokane, WA 99205. Label declares: INGREDIENTS: Contains Soy and Wheat. *** Soy Sauce (Water, Soybeans, Wheat, Salt ***Squid Sauce (Anchovy Extract) ***Sesame Oil***.
Ingredients statement declares Anchovy and Sasame, but Contains statement does not declare Fish (Anchovy) and Sesame.
FDA DevicesOmnipod 5 Pods. Model/Catalog number: PT-001662 ASM 5PK Pod STRL OPS G6G7
Omnipod 5 Pods. Model/Catalog number: PT-001662 ASM 5PK Pod STRL OPS G6G7
Due to a manufacturing defect, certain Omnipod 5 Pods from 49 lots have an internal soft cannula tear that results in insulin leaking into the Pod instead of being delivered to the user regardless of basal or bolus delivery. This defect results from damage to the unexposed portion of the soft cannula during manufacturing, which would result in a compromised fluid path. The primary failure mode is pump under-delivery due to loss of insulin to an internal leak; in some cases, the defect may also lead to pump shutoff and cessation of insulin delivery when leaked insulin contacts Pod circuity in a manner that results in an electrical short. Under-delivery of insulin (both basal and bolus insulin) or cessation of insulin put users at risk of hyperglycemia, and complications from acute and chronic hyperglycemia, including dehydration, blurry vision, nausea, vomiting, altered mental status, diabetic ketoacidosis (DKA), hyperglycemic hyperosmolar syndrome (HHS), or even death. Users may require hospitalization or medical intervention to treat severe adverse health consequences. Not all devices with the defect will issue an alarm or alert the user. If there is sufficient leakage of insulin to cause a short in the circuity, the Pod will issue a Hazard Alarm that stops all insulin delivery and alerts the user to replace their Pod. In addition, if a user s glucose is trending high and is not responding to insulin delivery, the system may reach the maximum amount of insulin microboluses allowed by the system and trigger the Automated Delivery Restriction (ADR) alert that tells users to check their blood glucose and take appropriate actions (i.e., ADR is a response to persistent hyperglycemia and maximum automated delivery constraints rather than a direct detection of the leak). The magnitude of under-delivery is unknown and based on multiple factors, including how much insulin is being delivered, whether an alarm and/or alert triggers, whether and when the user recognizes the device defect, the duration of Pod use, and the size of the tear.
FDA DrugsSemaglutide-Glycine-Cyanocobalamin Injectable, 2.5 mg, 5 mg, 1 MG/ML, 0.5 mL vials, Rx only, Northwest Compounders, Beaverton, OR
Semaglutide-Glycine-Cyanocobalamin Injectable, 2.5 mg, 5 mg, 1 MG/ML, 0.5 mL vials, Rx only, Northwest Compounders, Beaverton, OR
Lack of Assurance of Sterility
FDA DrugsSLMD BP Acne Spot Treatment, 10% Benzoyl Peroxide, 0.5 fl. oz - 15 mL bottles, Sandra Lee MD, Distributed by Skin PS Brands, Culver City, CA90232.
SLMD BP Acne Spot Treatment, 10% Benzoyl Peroxide, 0.5 fl. oz - 15 mL bottles, Sandra Lee MD, Distributed by Skin PS Brands, Culver City, CA90232.
Chemical contamination: Presence of benzene
FDA DrugsQC Quality Choice, Menthol-Cough Suppressant Oral Anesthetic, Cough Drops, Honey Lemon Flavor, 30-count bag, Distributed By: CDMA Inc., Novi, MI 48375, Made in China, NDC: 83698-617-30, UPC: 63551598673.
QC Quality Choice, Menthol-Cough Suppressant Oral Anesthetic, Cough Drops, Honey Lemon Flavor, 30-count bag, Distributed By: CDMA Inc., Novi, MI 48375, Made in China, NDC: 83698-617-30, UPC: 63551598673.
This recall is being initiated following FDA's recommendation based on certain observations noted during an August 15, 2025, inspection of the manufacturing facility that may bear on product quality.
FDA DevicesArjo Tenor mobile passive patient lift, Model Numbers KHA1000 US and KHA1010 US
Arjo Tenor mobile passive patient lift, Model Numbers KHA1000 US and KHA1010 US
An internal component of the actuators in a certain production batch may not meet the required mechanical strength. This could result, in the worst case scenario, in a sudden loss of the actuator's ability to hold the load, leading to rapid and uncontrolled downward movement of the lifting arm.
FDA DrugsQC Quality Choice, Menthol-Cough Suppressant Oral Anesthetic, Cough Drops, Vanilla Honey Flavor, 30-count bag, Distributed By: CDMA Inc., Novi, MI 48375, Made in China, NDC: 83698-620-30, UPC: 635515999411.
QC Quality Choice, Menthol-Cough Suppressant Oral Anesthetic, Cough Drops, Vanilla Honey Flavor, 30-count bag, Distributed By: CDMA Inc., Novi, MI 48375, Made in China, NDC: 83698-620-30, UPC: 635515999411.
This recall is being initiated following FDA's recommendation based on certain observations noted during an August 15, 2025, inspection of the manufacturing facility that may bear on product quality.
FDA DrugsCinacalcet Hydrochloride Tablets, 90 mg, 30 Tablets per bottle, Rx Only, Manufactured by: Cipla Ltd., MIDC, Patalganga, India; Manufactured for: Cipla USA, Inc., 10 Independence Boulevard, Suite 300, Warren, NJ 07059. NDC: 69097-412-02
Cinacalcet Hydrochloride Tablets, 90 mg, 30 Tablets per bottle, Rx Only, Manufactured by: Cipla Ltd., MIDC, Patalganga, India; Manufactured for: Cipla USA, Inc., 10 Independence Boulevard, Suite 300, Warren, NJ 07059. NDC: 69097-412-02
CGMP Deviations; presence N-Nitroso Cinacalcet above the acceptable daily intake limit
FDA DevicesInstinct Plus Endoscopic Clipping Device REF: G58010 Rx Only, Sterile EO
Instinct Plus Endoscopic Clipping Device REF: G58010 Rx Only, Sterile EO
Due to increased in complaints their is the potential for endoscopic clipping device to malfunction.
FDA DrugsFHF Farmhouse Fresh, Midnight Clearing, NIGHT LOTION, 2.5% BENZOYL PEROXIDE ACNE TREATMENT, OTC a) 0.5 fl. oz./15ml; and b)1 fl. oz./30ml tubes; Made in the USA for FarmHouse Fresh, 8797 CR 858 McKinney, Texas
FHF Farmhouse Fresh, Midnight Clearing, NIGHT LOTION, 2.5% BENZOYL PEROXIDE ACNE TREATMENT, OTC a) 0.5 fl. oz./15ml; and b)1 fl. oz./30ml tubes; Made in the USA for FarmHouse Fresh, 8797 CR 858 McKinney, Texas
Chemical contamination: Presence of benzene
FDA DrugsQC Quality Choice, Pectin Oral Demulcent, Throat Soothing Drops, Creamy Strawberry Flavor, 30-count bag, Distributed By: CDMA, Inc., Novi, MI 48375, Made in China, NDC: 83698-625-30, UPC: 635515999398.
QC Quality Choice, Pectin Oral Demulcent, Throat Soothing Drops, Creamy Strawberry Flavor, 30-count bag, Distributed By: CDMA, Inc., Novi, MI 48375, Made in China, NDC: 83698-625-30, UPC: 635515999398.
This recall is being initiated following FDA's recommendation based on certain observations noted during an August 15, 2025, inspection of the manufacturing facility that may bear on product quality.
FDA DrugsDesmopressin Nasal Spray, USP, 10 mcg/0.1 mL, 5 mL bottle (50 doses), Rx only, Mfg by: Apotek inc., Toronto, Ontario, Canada, M9L 1T9, Mfg for: Apotek Corp., Weston, FL 33326, NDC 60505-0815-0
Desmopressin Nasal Spray, USP, 10 mcg/0.1 mL, 5 mL bottle (50 doses), Rx only, Mfg by: Apotek inc., Toronto, Ontario, Canada, M9L 1T9, Mfg for: Apotek Corp., Weston, FL 33326, NDC 60505-0815-0
Defective container: defect in a batch of bottle caps, specifically involving dislodged or missing cap liners.