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.
- 2014-07-30FDA-DrugEstee Lauder IncClass IIIDENBLAN Anticavity Fluoride Toothpaste, Whitening formula, sodium monofluorophosphate 0.76%, 2.6 oz/75 mL tube, Laboratories Darphin, Dist, Paris France
Stability Data Does Not Support Expiry
- 2014-07-30NHTSA-EquipmentRecaro Child Safety, LLCRecaro Child Safety, LLC — Tether and Anchorage Failure/FMVSS 213
If the top tether anchorage detaches from the child restraint, there is an increased risk of injury to the child or other vehicle occupants.
- 2014-07-24CPSCMayborn USA, Inc.Mayborn USA Recalls to Repair Baby Monitors Due to Strangulation Hazard
Child can pull sensor pad cord into crib and wrap around the neck, posing a strangulation hazard.
- 2014-07-23CPSCDream On Me, of South Plainfield, N.J.Dream On Me Recalls High Chairs Due to Strangulation and Fall Hazards
The leg or side opening of the chair can allow a child's body to pass through and become entrapped at the neck or fall from the chair. This poses a strangulation and fall hazard to young children.
- 2014-07-22CPSCOeuf LLC, of Brooklyn, N.Y.Oeuf Recalls to Repair Cribs Due to Entrapment Hazard
The slats/spindles and top rail can detach from the cribs and pose an entrapment hazard to a child.
- 2014-07-18USDAClass ICheck Harris Teeter grilled chicken strips for allergen risk
Misbranding, Unreported Allergens
- 2014-07-14CPSCGlaxoSmithKline (GSK), of Moon Township, Penn.GSK Recalls Panadol Advance Bottles Due to Failure to Meet Child-Resistant Closure Requirement; Sold Exclusively in Puerto Rico
The packaging is not child-resistant as required by the Poison Prevention Packaging Act. These products contain acetaminophen which is required by the Poison Prevention Packaging Act to be sealed with child-resistant packaging.
- 2014-07-12USDAClass ICheck freezer for recalled Foster Farms chicken
Product Contamination
- 2014-07-02FDA-DeviceElekta, Inc.Class IIMOSAIQ MOSAIQ is an oncology information system used to manage workflows for treatment planning and delivery. It supports information flow among healthcare facility personnel and can be used where ever radiotherapy and/or chemotherapy are prescribed.
MOSAIQ does not re-calculate the agent volume when the user changes the ordering dose (to other than what was calculated) prior to saving the order.
- 2014-07-02FDA-DeviceIntegra LifeSciences Corp.Class IIAccell Evo3C Demineralized Bone Matrix, 5 cc, Model Number: 02-6000-050 , Lot Number: 132160. Product Usage: Accell Evo3c Demineralized Bone Matrix Putty is intended for filling voids and gaps in the skeletal system that are not intrinsic to the stability of the bony structure. Accell Evo3c is indicated for use as a bone graft extender in the spine, extremities and pelvis, or as a bone void filler in the extremities and pelvis. The voids or gaps may be surgically created defects or
This lot of Accell Evo3C Demineralized Bone Matrix, 5cc was incorrectly packaged in boxes that describe the product as Accell Evo3 Demineralized Bone Matrix. Evo3C is contraindicated for treatment of vertebral compression and not indicated for use in the posterolateral spine.
- 2014-07-02FDA-DeviceNellcor Puritan Bennett Inc. (dba Covidien LP)Class IIPuritan Bennett 840 Ventilator (4-840120DIUU-XX) The PB840 Ventilator System is intended to provide invasive or non-invasive ventilatory support and monitoring for infant, pediatric, and adult patients with respiratory failure or respiratory insufficiency. It is used in hospitals and healthcare facilities.
Covidien is conducting a medical device field correction for specific Puritan Bennett 840 Ventilators due to customer reports of loss of graphical user interface (GUI) display information while the ventilator continues to provide breath support.
- 2014-06-30NHTSA-EquipmentGraco Children's Products, Inc.Graco Children's Products, Inc. — Buckle may not Unlatch
It may be 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.
- 2014-06-26USDAClass IIDon't eat Mr. Wok Foods pork nuggets
Misbranding, Unreported Allergens
- 2014-06-25FDA-DeviceNellcor Puritan Bennett Inc. (dba Covidien LP)Class IIModel Number(s): PB840 Ventilator (4-840120DIUU-XX). The product is a component of the Puritan Bennett 840 Ventilator: The Backlight Inverter Printed Circuit Board (BLI PCBA) for the 9.4 Display part number 4-079056-00. The PB840 Ventilator System is intended to provide invasive or non-invasive ventilator support and monitoring for infant, pediatric, and adult patients with respiratory failure or respiratory insufficiency. It is used in hospitals and healthcare facilities
In the case of a loss of GUI display due to a Backlight Inverter PCBA failure, the ventilator continues to provide uninterrupted ventilatory support at the programmed settings for the patient. However, there is a loss of display and thus there is a necessity to move the patient to another ventilator.
- 2014-06-25FDA-DeviceElekta, Inc.Class IIMOSAIQ, an oncology information system used to manage workflows for treatment planning and delivery. It supports information flow among healthcare facility personnel and can be used wherever radiotherapy and/or chemotherapy are prescribed.
When using CMA, if the user hovers the mouse pointer exactly above the direction dropdowns and then uses the mouse thumbwheel or touchpad scroll bar, the direction selection might change when the intention was only to move the mouse to a different area of the screen.
- 2014-06-25FDA-DeviceChildrens Medical VenturesClass IIPhilips/Children's Medical Ventures Smart Monitor 2 Professional Series infant apnea monitor.
The battery pack wire harness is improperly assembled rendering the device inoperable. The wiring issue causes an error code to be displayed and results in the device sounding an alarm repeatedly at power up. The presence of the error code and the devices alarm prevents the device from functioning until the issue is addressed.
- 2014-06-25FDA-DeviceConvatec Inc.Class IConvatec Flexi Seal Control Fecal Management System Rx Only REF 411107 Product Usage:For use to manage fecal incontinence through the collection of liquid to semi-liquid stool and to provide access to administer medications as prescribed by a physician.
Convatec Inc. is recalling Flexi-seal FMS Control Kit since it does not have a 510K. In addition, an internal assessment of product performance, including a review of customer feedback, has confirmed that Flexi-Seal Control is not meeting expectations or those of customers. Specifically, the Auto-Valve feature that is unique to the Flexi-Seal Control has not been consistently performing relative
- 2014-06-25USDAClass IIFirma En Iowa Retira Del Mercado Salchichas Que Contienen Soya Y Trigo Debido A Error En Rotulación Y Alérgenos No Identificados
Misbranding, Unreported Allergens
- 2014-06-21USDAClass IDon't eat Wei-Chuan pork mini buns
Misbranding, Unreported Allergens
- 2014-06-19USDAClass IIStop eating Randy's Slab Bacon if you have soy allergy
Misbranding, Unreported Allergens
- 2014-06-18FDA-DeviceSakura Finetek USA IncClass IITissue-Tek PARAFORM PROC/EMB/MEDIUM, FORMULA 3 - 8x1Kg. for diagnostic chemistry use. Sakura Finetek USA, Inc.
This Lot has variations in melting temperature.
- 2014-06-18FDA-DeviceFresenius Medical Care Holdings, Inc.Class IIINaturaLyte¿ Liquid Bicarbonate Concentrate, 6.4 liter bottle to be used with a hemodialysis unit; Part 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.
Container cap may contain foreign material- 0.60% - 0.80% Manganese
- 2014-06-18FDA-DrugMyNicNaxs, Inc.Class IPill for weight reduction, (Japanese Chinese Formula from Japan Hokkaido Cangye Pharmacy Co, Ltd) 400 mg, supplied in 40 count boxes, distributed by MyNicKnaxs, LLC, Deltona, FL
Marketed Without an Approved NDA/ANDA: Product was found to contain undeclared active pharmaceutical ingredient: Phenolphthalein
- 2014-06-18FDA-DrugVitality Research Labs LLCClass IvitaliKOR Ready When You Are, Fast Acting Formula Dietary Supplement capsules, 40 count bottle, Distributed by Vitality Research Labs, LLC, Las Vegas, NV 89148.
Marketed Without an Approved NDA/ANDA: FDA sampling found undeclared vardenafil and tadalafil in vitaliKOR capsules
- 2014-06-11FDA-FoodSTE FROMAGERE DU LIVRADOISClass IMontboissie du haut- Livradois Manufactured by Ste Fromagere du Livradois 63980 Fournols 13lbs or cut and wrapped (weight may vary) wrapped in a wax paper in a case or wrapped in plastic wrap if cut; refrigerated
Ste Fromagere du Livradois of Fournols, France is recalling Haut Livradois brand Raclette and Montboissie cheeses lot#350 because they have the potential to be contaminated with Salmonella, an organism which can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems.
- 2014-06-11FDA-FoodSTE FROMAGERE DU LIVRADOISClass IRaclette du Haut Livradois Ste Fromagere du Livradois 63980 Fournols 13lbs or cut and wrapped (weight may vary) wrap in a wax paper in a case or wrapped in plastic wrap if cut; refrigerated
Ste Fromagere du Livradois of Fournols, France is recalling Haut Livradois brand Raclette and Montboissie cheeses lot#350 because they have the potential to be contaminated with Salmonella, an organism which can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems.
- 2014-06-04CPSCLea Industries, of High Point, N.C.Lea Industries Recalls Bunk Beds with Bookcases Due to Risk of Entrapment (Recall Alert)
The bunk bed can be assembled incorrectly, creating a space that exceeds the 1.88 inches allowed by the industry standard, posing an entrapment hazard to young children.
- 2014-06-04CPSCphil&teds, of Fort Collins, Colo.phil&teds Recalls Infant Car Seat Adaptors for Strollers Due to Fall Hazard
The plastic adaptors used to connect an infant car seat to a stroller can crack, become unstable and break during use, posing a fall hazard to infants.
- 2014-05-29USDAClass IIIStop using Boulder Natural Meats chicken breasts
Misbranding
- 2014-05-28FDA-DeviceSiemens Healthcare Diagnostics, Inc.Class IIDimension Vista¿ CSA and CSAE The Cyclosporine method is an in vitro diagnostic test for the quantitative measurement of cyclosporine A (CSA) in human whole blood on the Dimension Vista¿ System. Measurements of CSA are used as an aid in the management of heart, liver and kidney transplant patients.
A complaint was received of Dimension Vista¿ CSA and CSAE under-recovery of cyclosporine when patient samples are run from the Small Sample Container. The under-recovery that has been observed is 18 to 44%. In March 2014, Siemens recalled due to the complaint received of Dimension Vista¿ CSA and CSAE reporting under-recovery of cyclosporine when patient samples are run from the Small Sample C
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