Baby and kids' product recalls
6675 federal recalls on file. Every federal recall touching baby and kids' products — toys, formula, baby food, cribs, strollers, child seats. Sourced from CPSC, FDA, USDA, and NHTSA, translated into plain English.
- 2014-11-05FDA-FoodHerb Garden ProductionsClass IHerbally Grounded Hello Blossom 120 ct Vegetarian Capsule Formula, bottle in 20cc food grade amber glass bottle. Manufacturer: Herbally Grounded LLC., Curtiss Harris 7023640090 3744 W. Meade Ave. Ste. 11a Las Vegas, NV 89102
Notified by immediate supplier that Nettle Leaf Powder may contain Salmonella after reports of a positive finding by a customer.
- 2014-10-29FDA-DeviceAerogen Ltd.Class IIThe Aeroneb Professional Nebulizer System is a portable medical device for multiple patient use that is intended to aerosolize physician-prescribed solutions for inhalation to patients on and off ventilation or other positive pressure breathing assistance. The Aeroneb Professional Nebulizer System is suitable for use in adult and pediatric patients. The Aeroneb Solo Nebulizer System is an iteration of the Aeroneb Professional Nebulizer System which is single patient use. The FRIWO AC/DC
Aerogen has received a small number of complaints in relation to the main power adapter manufactured by FRIWO GmbH and used in the Aeroneb Solo and Pro Nebuliser systems. The complaints received identified that the power adapter cover had broken and dislodged from the body of the adapter prior to use.
- 2014-10-29FDA-DeviceAerogen Ltd.Class IIThe Aeroneb Professional Nebulizer System is a portable medical device for multiple patient use that is intended to aerosolize physician-prescribed solutions for inhalation to patients on and off ventilation or other positive pressure breathing assistance. The Aeroneb Professional Nebulizer System is suitable for use in adult and pediatric patients. The Aeroneb Solo Nebulizer System is an iteration of the Aeroneb Professional Nebulizer System which is single patient use. The FRIWO AC/DC
Aerogen has received a small number of complaints in relation to the main power adapter manufactured by FRIWO GmbH and used in the Aeroneb Solo and Pro Nebuliser systems. The complaints received identified that the power adapter cover had broken and dislodged from the body of the adapter prior to use.
- 2014-10-29FDA-DeviceAerogen Ltd.Class IIThe Aeroneb Professional Nebulizer System is a portable medical device for multiple patient use that is intended to aerosolize physician-prescribed solutions for inhalation to patients on and off ventilation or other positive pressure breathing assistance. The Aeroneb Professional Nebulizer System is suitable for use in adult and pediatric patients. The Aeroneb Solo Nebulizer System is an iteration of the Aeroneb Professional Nebulizer System which is single patient use. The FRIWO AC/DC
Aerogen has received a small number of complaints in relation to the main power adapter manufactured by FRIWO GmbH and used in the Aeroneb Solo and Pro Nebuliser systems. The complaints received identified that the power adapter cover had broken and dislodged from the body of the adapter prior to use.
- 2014-10-29FDA-DeviceAerogen Ltd.Class IIThe Aeroneb Professional Nebulizer System is a portable medical device for multiple patient use that is intended to aerosolize physician-prescribed solutions for inhalation to patients on and off ventilation or other positive pressure breathing assistance. The Aeroneb Professional Nebulizer System is suitable for use in adult and pediatric patients. The Aeroneb Solo Nebulizer System is an iteration of the Aeroneb Professional Nebulizer System which is single patient use. The FRIWO AC/DC
Aerogen has received a small number of complaints in relation to the main power adapter manufactured by FRIWO GmbH and used in the Aeroneb Solo and Pro Nebuliser systems. The complaints received identified that the power adapter cover had broken and dislodged from the body of the adapter prior to use.
- 2014-10-29FDA-DeviceRespironics California IncClass IEsprit V1000 and V200 Ventilators, Model No. V1000 and V200; and the 3rd Generation Power Supply Repair Part (RP)Kits Microprocessor-controlled, electrically powered mechanical ventilators intended for use by qualified medical personnel to provide continuous or intermittent ventilator support for adult, pediatric and neonatal patients as prescribed by a physician.
A failure of a specific component may prevent the ventilators from operating on AC power or transitioning back to AC power when operating on battery. Additionally, if a battery is not present or is depleted the ventilators will not operate. This failure will cause the loss of ventilator support, which may result in hypercarbia or hypoxemia.
- 2014-10-29FDA-FoodPlum, Inc.Class IIPlum Organics Little Cremes: Organic Rice Milk Snacks; Super Reds: Pomegranate, Beet and Berry; Net Wt. 1 oz. (28 grams) 8 CT. USDA Organic; Dairy Free. Ingredients:ORGANIC SWEET POTATO PUREE, ORGANIC STRAWBERRY PUREE, ORGANIC POMEGRANATE JUICE CONCENTRATE, ORGANIC RICE MILK (ORGANIC BROWN RICE, WATER), ORGANIC EVAPORATED CANE SYRUP, ORGANIC TAPIOCA STARCH, ORGANIC BEET JUICE CONCENTRATE Plum Inc., Emeryville, CA 94608
Increased number of complaints that product is not softening as intended and causes a potential choking hazard in babies and young children,.
- 2014-10-29FDA-FoodPlum, Inc.Class IIPlum Organics Little Cremes: Organic Rice Milk Snacks; Super Purples: Acai, Blackberry and Purple Carrot; Net Wt. 1 oz. (28 grams) 8 CT. USDA Organic; Dairy Free. Ingredients: ORGANIC SWEET POTATO PUREE, ORGANIC BLACKBERRY PUREE, ORGANIC APPLE PUREE, ORGANIC ACAI PUREE, ORGANIC RICE MILK (ORGANIC BROWN RICE, WATER), ORGANIC EVAPORATED CANE SYRUP, ORGANIC TAPIOCA STARCH, ORGANIC PURPLE CARROT JUICE CONCENTRATE, NATURAL FLAVOR. Plum Inc., Emeryville, CA 94608
Increased number of complaints that product is not softening as intended and causes a potential choking hazard in babies and young children,.
- 2014-10-29FDA-FoodPlum, Inc.Class IIPlum Organics Little Cremes: Organic Rice Milk Snacks; Super Greens: Kale, Apple and Sweet Potato; Net Wt. 1 oz. (28 grams) 8 CT. USDA Organic; Dairy Free. Ingredients: ORGANIC SWEET POTATO PUREE, ORGANIC APPLE PUREE, ORGANIC RICE MILK (ORGANIC BROWN RICE, WATER), ORGANIC EVAPORATED CANE SYRUP, ORGANIC TAPIOCA STARCH, ORGANIC DRIED KALE, ORGANIC APPLE FLAVOR, ORGANIC CINNAMON. Plum Inc., Emeryville, CA 94608
Increased number of complaints that product is not softening as intended and causes a potential choking hazard in babies and young children,.
- 2014-10-29FDA-DrugQualitest PharmaceuticalsClass IICHILDREN'S Q-PAP, Acetaminophen, ORAL SUSPENSION, GRAPE FLAVOR, Active ingredient (in each 5 mL = 1 tsp) Acetaminophen USP 160 mg, 4 FL OZ (118 mL), Made in the USA for Qualitest Pharmaceuticals, Huntsville, AL 35811, NDC 0603-0843-54, OTC
Superpotent Drug: Qualitest Pharmaceuticals is initiating a recall of three flavors of Acetaminophen Oral Suspension Liquid 160mg/5mL for failure of the product assay at the 12 month timepoint.
- 2014-10-29FDA-DrugQualitest PharmaceuticalsClass IICHILDREN'S Q-PAP, Acetaminophen, ORAL SUSPENSION, CHERRY FLAVOR, Active ingredient (in each 5 mL = 1 tsp) Acetaminophen USP 160 mg, 4 FL OZ (118 mL), Made in the USA for Qualitest Pharmaceuticals, Huntsville, AL 35811, NDC 0603-0842-54, OTC
Superpotent Drug: Qualitest Pharmaceuticals is initiating a recall of three flavors of Acetaminophen Oral Suspension Liquid 160mg/5mL for failure of the product assay at the 12 month timepoint.
- 2014-10-29FDA-DrugQualitest PharmaceuticalsClass IICHILDREN'S Q-PAP, Acetaminophen, ORAL SUSPENSION, BUBBLE GUM FLAVOR, Active ingredient (in each 5 mL = 1 tsp) Acetaminophen USP 160 mg, 4 FL OZ (118 mL), Made in the USA for Qualitest Pharmaceuticals, Huntsville, AL 35811, NDC 0603-0841-54, OTC
Superpotent Drug: Qualitest Pharmaceuticals is initiating a recall of three flavors of Acetaminophen Oral Suspension Liquid 160mg/5mL for failure of the product assay at the 12 month timepoint.
- 2014-10-29FDA-DrugBio-pharm, Inc.Class IIRugby Children's Pain and Fever Acetaminophen Oral Suspension 160 mg/5 mL, Cherry Flavor, 2 FL. oz bottle, OTC, Distributed by: Rugby Laboratories Livonia, MI 48150, NDC 0536-3606-96 Major Children's Mapap Suspension Liquid, Cherry Flavor, 4 FL OZ bottle, OTC, Distributed by: Major Pharmaceuticals Livonia, MI 48150 , NDC 0904-6308-20,
Superpotent Drug: Bio-Pharm, Inc. is initiating a recall of one lot of Acetaminophen Oral Suspension Liquid 160mg/5mL failure of the product assay at the 6 month timepoint.
- 2014-10-24USDAClass IDon't eat Antioch Farms chicken Kiev
Product Contamination
- 2014-10-22FDA-DeviceStryker Howmedica Osteonics Corp.Class IIStryker T2 Tibia System Nail Insertion Sleeve, Elastic, Sterile, a) REF 1806-1406S, SPI 08-11 and b) REF 1806-1407S, SPI 08-13. Product Usage: The T2 Tibial Nailing system is intended to provide temporary stabilization of various types of fractures, malunion and nonunion of the tibia. The nails are inserted using an opened or closed technique and can be statically, dynamically and compressed locked. The system is indicated for long bone fracture fixation, specifically tibial fracture fixatio
Stryker Orthopaedics received a report indicating some of the Nail Insertion Sleeves had a different inner diameter than described on the package label.
- 2014-10-20NHTSA-EquipmentEvenflo Company, Inc.Evenflo Company, Inc. — Buckle may not Unlatch
A buckle that does not release easily, or possibly at all, may make it difficult to remove the child from the restraint, increasing the risk of injury in the event of a vehicle crash, fire, or other emergency, in which a prompt exit from the vehicle is required.
- 2014-10-16CPSCAmerican Honda Motor Company, of Torrance, Calif.American Honda Recalls Recreational Off-Highway Vehicles Due to Fire Hazard (Recall Alert)
Vegetation and debris can accumulate on the middle skid plate and make contact with the vehicle's exhaust system. Dried debris can ignite, resulting in smoke or fire.
- 2014-10-15FDA-DeviceMckesson Information Solutions LLCClass IIMcKesson Cardiology" Hemo intended for complete physiological/hemodynamic monitoring, clinical data acquisition, medical image and data processing, and analytical assessment.
Software Error: The McKesson Cardiology Hemo calculation section incorrectly converts the Hemoglobin value before it is utilized in the applicable formula calculations.
- 2014-10-15FDA-FoodAMS Health SciencesClass IIsaba; ACE; Appetite Control Energy; 052234; 07/2015; Distributed by Saba; 711 NE 39th Street, Oklahoma City, OK 73105
Product called SABA ACE (Appetite Control Energy) that was manufactured prior to September 2013 was found to have DMAA (1,3-Dimethylpentylamine) based on label and laboratory analysis. the DMAA was removed when the product was reformulated in September 2013.
- 2014-10-08FDA-DeviceSiemens Medical Solutions USA, Inc.Class IIThe Symbia Intevo series consists of the Intevo 16, Intevo 6 and Intevo 2. This manual also describes the Symbia Intevo Excel. The Symbia Intevo series integrates state-of-the-art SPECT and high quality spiral CT to provide precise attenuation correction and anatomical mapping. The system can also be used as a complete clinical SPECT system for general purpose, whole body (WB) and SPECT applications. The Symbia Intevo Excel integrates state-of-the-art SPECT and high quality spiral CT to give t
Siemens Medical Solutions USA, Inc. is performing a field correction because we recently detected a rubber isolator with unfavorable aging properties. The function of the rubber isolator, which is situated within the rotate motor mounting assembly, may degrade over time and may impact motor support. The event does not pose a hazard by itself but could lead to a rupture of the drive belt which in t
- 2014-10-08FDA-FoodTradewind Foods de Puerto Rico Inc.Class IIGoya Red Kidney Beans Habichuelas Coloradas 15.5 oz. (439 g)
Goya de Puerto Rico is recalling the following products due to a possible can seam defect that may compromise the integrity of the product.
- 2014-10-02CPSCToys R Us Inc., of Wayne, N.J.Toys R Us Recalls Children’s Sandals Due to Choking Hazard
The butterfly wings on the children's sandals can rip and detach, posing a choking hazard to young children.
- 2014-10-01FDA-DeviceVapotherm, Inc.Class IIVapotherm Precision Flow,Disposable Patient Circuit PFHDPC-Low. For use with the Heliox Precision Flow system Precision Flow" is intended for use to add warm moisture to breathing gases from an external source for administration to a neonate/infant, pediatric and adult patients in the hospital, sub-acute institutions, and home settings. It adds heat and moisture to blended medical air/oxygen mixture and assures the integrity of the precise air/oxygen mixture via an integral oxygen analyzer.
Disposable Patient Circuit that allows water to leak into the center gas lumen
- 2014-10-01FDA-DeviceVapotherm, Inc.Class IIVapotherm Precision Flow,Disposable Patient Circuit PF-DPC-Low. For use with the Precision Flow system Precision Flow" is intended for use to add warm moisture to breathing gases from an external source for administration to a neonate/infant, pediatric and adult patients in the hospital, sub-acute institutions, and home settings. It adds heat and moisture to blended medical air/oxygen mixture and assures the integrity of the precise air/oxygen mixture via an integral oxygen analyzer. The flow
Disposable Patient Circuit that allows water to leak into the center gas lumen
- 2014-10-01FDA-DeviceVapotherm, Inc.Class IIVapotherm Precision Flow,Disposable Patient Circuit PFNODPC-High. For use with the Precision Flow system and Ikaria INOmax DSIR ¿ System. This DPC allows clinicians to administer nitric oxide non-invasively via high flow nasal cannula. In the Precision Flow High Flow Therapy application, a special disposable patient circuit re-routes the gas to the INOmax injector module then back into the Precision Flow system Precision Flow" is intended for use to add warm moisture to breathing gases f
Disposable Patient Circuit that allows water to leak into the center gas lumen
- 2014-10-01FDA-DeviceVapotherm, Inc.Class IIVapotherm Precision Flow,Disposable Patient Circuit PFH-DPC-High. For use with the Heliox Precision Flow system Precision Flow" is intended for use to add warm moisture to breathing gases from an external source for administration to a neonate/infant, pediatric and adult patients in the hospital, sub-acute institutions, and home settings. It adds heat and moisture to blended medical air/oxygen mixture and assures the integrity of the precise air/oxygen mixture via an integral oxygen analyzer
Disposable Patient Circuit that allows water to leak into the center gas lumen
- 2014-10-01FDA-DeviceVapotherm, Inc.Class IIVapotherm Precision Flow,Disposable Patient Circuit PF-E-DPC-High. For use with the Precision Flow system Precision Flow" is intended for use to add warm moisture to breathing gases from an external source for administration to a neonate/infant, pediatric and adult patients in the hospital, sub-acute institutions, and home settings. It adds heat and moisture to blended medical air/oxygen mixture and assures the integrity of the precise air/oxygen mixture via an integral oxygen analyzer. The
Disposable Patient Circuit that allows water to leak into the center gas lumen
- 2014-10-01FDA-DeviceVapotherm, Inc.Class IIVapotherm Precision Flow, Disposable Patient Circuit PF-DPC-High. For use with the Precision Flow system Precision Flow" is intended for use to add warm moisture to breathing gases from an external source for administration to a neonate/infant, pediatric and adult patients in the hospital, sub-acute institutions, and home settings. It adds heat and moisture to blended medical air/oxygen mixture and assures the integrity of the precise air/oxygen mixture via an integral oxygen analyzer. The f
Disposable Patient Circuit that allows water to leak into the center gas lumen
- 2014-10-01FDA-DeviceCarefusion 2200 IncClass IICareFusion AirLife Heated Infant Breathing Circuit Product Usage: Respiratory breathing circuits are used with a ventilator when mechanical ventilation is administered to a patient.
The CareFusion AirLife Heated Infant Breathing Circuit is being recalled due to a regulatory compliance risk involving a material change. The changes to the gas pathway may potentially impact the safety of the device and quality of the gas condensates to the patient.
- 2014-10-01FDA-DeviceFresenius Medical Care Holdings, Inc.Class IIFresenius Naturalyte Liquid Bicarbonate Concentrate Product Number: 08-4000-LB The concentrate is formulated to be used with a three steam hemodialysis machine which is calibrated for acid and bicarbonate concentrates.
Product was held at temperature above the labeled recommended storage temperature
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