Vereinigte Staaten Recalls
Verbraucherrückrufe von FDA, CPSC, NHTSA und USDA FSIS.
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.
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.
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.
CPSCCpzzkq Baby Loungers Recalled Due to Risk of Serious Injury or Death from Suffocation Hazard; Violates Mandatory Standard for Infant Support Cushions; Sold on Amazon by CetoPMax
Cpzzkq Baby Loungers Recalled Due to Risk of Serious Injury or Death from Suffocation Hazard; Violates Mandatory Standard for Infant Support Cushions; Sold on Amazon by CetoPMax
The recalled baby loungers violate the mandatory safety standard for infant support cushions because the padding can obstruct an infant's breathing, posing a serious risk of injury or deadly suffocation hazard.
CPSCChildren's Tower Stools Recalled Due to Risk of Serious Injury and Death from Entrapment and Fall Hazards; Imported by TOETOL HOME
Children's Tower Stools Recalled Due to Risk of Serious Injury and Death from Entrapment and Fall Hazards; Imported by TOETOL HOME
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.
CPSCTzumi Electronics Recalls FitRx SmartBell Quick-Select Adjustable Dumbbells Due to Serious Injury from Impact Hazard
Tzumi Electronics Recalls FitRx SmartBell Quick-Select Adjustable Dumbbells Due to Serious Injury from Impact Hazard
Weight plates can dislodge from the handle during use, posing a risk of serious injury due to impact hazard.
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.
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.
FDA DevicesCytal Wound Matrix 2-Layer 10x15 cm. Product ID: WSM1015.
Cytal Wound Matrix 2-Layer 10x15 cm. Product ID: WSM1015.
Increased rate of out-of-specification endotoxin results.
FDA DrugsFluocinonide, USP, 0.05% Cream, 30g tube, Rx only, Mfd by: Taro Pharmaceuticals Inc., Brampton, Ontario, Canada L6T 1C1, Dist. by: Taro Pharmaceuticals U.S.A., Inc., Hawthorne, NY 10532, NDC 51672-1386-2.
Fluocinonide, USP, 0.05% Cream, 30g tube, Rx only, Mfd by: Taro Pharmaceuticals Inc., Brampton, Ontario, Canada L6T 1C1, Dist. by: Taro Pharmaceuticals U.S.A., Inc., Hawthorne, NY 10532, NDC 51672-1386-2.
Failed Viscosity Specifications: Out of Specification results, above the specification limit, in viscosity, noted during stability testing.
FDA DevicesCytal Burn Matrix 7x10 cm. Product ID: BMM0710.
Cytal Burn Matrix 7x10 cm. Product ID: BMM0710.
Increased rate of out-of-specification endotoxin results.
FDA FoodRaw & Unfiltered Bee Well Wildflower Honey NET wT. 12 OZ (340g) UPC 8 32587 00003 2, NET WT. 22 OZ (624g) UPC 8 32587 00002 5 & NET WT. 44 OZ (1.25g) UPC 8 32587 00001 8 100% Pure Honey Bee Well Honey 909 W. Main Street Pickens, SC 29671
Raw & Unfiltered Bee Well Wildflower Honey NET wT. 12 OZ (340g) UPC 8 32587 00003 2, NET WT. 22 OZ (624g) UPC 8 32587 00002 5 & NET WT. 44 OZ (1.25g) UPC 8 32587 00001 8 100% Pure Honey Bee Well Honey 909 W. Main Street Pickens, SC 29671
High sugar content. The firm was notified by the FDA that sample results were positive for a high C4 sugar content.
FDA DrugsFluocinonide, USP, 0.05% Cream, 15g tube, Rx only, Mfd by: Taro Pharmaceuticals Inc., Brampton, Ontario, Canada L6T 1C1, Dist. by: Taro Pharmaceuticals U.S.A., Inc., Hawthorne, NY 10532, NDC 51672-1386-1
Fluocinonide, USP, 0.05% Cream, 15g tube, Rx only, Mfd by: Taro Pharmaceuticals Inc., Brampton, Ontario, Canada L6T 1C1, Dist. by: Taro Pharmaceuticals U.S.A., Inc., Hawthorne, NY 10532, NDC 51672-1386-1
Failed Viscosity Specifications: Out of Specification results, above the specification limit, in viscosity, noted during stability testing.
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 DevicesYeastone Broth, 11ML, 10/BOX YY3462
Yeastone Broth, 11ML, 10/BOX YY3462
Products may report incorrect AST results during quality control. Health consequences may include delayed response or the need to change to another antifungal agent if laboratory ignores Quality Control test result.
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 DevicesReact Health PHOENIX 5L Oxygen Concentrator
React Health PHOENIX 5L Oxygen Concentrator
Devices which did not meet internal quality specifications were inadvertently distributed.
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.
FDA DevicesB. Braun Hemodialysis Bloodlines, STREAMLINE FRESENIUS FOR DAVITA. Model Number: SL-2000M2095DA.
B. Braun Hemodialysis Bloodlines, STREAMLINE FRESENIUS FOR DAVITA. Model Number: SL-2000M2095DA.
Potential for the accumulation of small air bubbles in the arterial line due to adherence of blood gases to the tubing under negative pressure.
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 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 DrugsMGC Health, Menthol- Cough Suppressant, Oral Anesthetic, Cough Drops, Sugar Free, Honey Lemon, 25-count bag, Distributed By: Medical Group Care, LLC, 1035 Collier Center Way, STE 5, Naples, FL 34110, NDC: 83698-125-25, UPC: 383173000085
MGC Health, Menthol- Cough Suppressant, Oral Anesthetic, Cough Drops, Sugar Free, Honey Lemon, 25-count bag, Distributed By: Medical Group Care, LLC, 1035 Collier Center Way, STE 5, Naples, FL 34110, NDC: 83698-125-25, UPC: 383173000085
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 DrugsQC Quality Choice, Menthol- Cough Suppressant Oral Anesthetic, Cough Drops, Cherry Flavor, 30-count bag, Distributed By: CDMA, Inc., Novi MI 48375, Made in China, NDC: 83698-616-25, UPC: 635515993372.
QC Quality Choice, Menthol- Cough Suppressant Oral Anesthetic, Cough Drops, Cherry Flavor, 30-count bag, Distributed By: CDMA, Inc., Novi MI 48375, Made in China, NDC: 83698-616-25, UPC: 635515993372.
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.