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.
- 2014-03-25CPSCTak Ngai Electronic Toys Co., LTDWal-Mart Recalls Dolls Due to Burn Hazard
The circuit board in the chest of the doll can overheat, causing the surface of the doll to get hot, posing a burn hazard to the consumer.
- 2014-03-20CPSCIKEA North America Services LLC, of Conshohocken, Pa.IKEA Recalls Children's Bed Canopies Due to Strangulation Hazard
An infant or young child can get entangled at the neck in the canopy's fabric, posing a strangulation hazard.
- 2014-03-19FDA-DeviceElekta, Inc.Class IIXiO RPT System The XiO RTP System is used to create treatment plans for any cancer patient for whom external beam radiation therapy or brachytherapy has been prescribed. The system will calculate and display, both on screen and in hard-copy, either two or three dimensional radiation dose distributions within a patient for a given treatment.
Dose and Monitor Unit values are not computed correctly when Elekta Motorized Wedges are used with Dynamic Conformal arcs.
- 2014-03-19FDA-DeviceMaquet Cardiovascular Us Sales, LlcClass IIMAQUET PLEGIOX Cardioplegia Heat Exchanger The PLEGIOX Cardioplegia Heat Exchanger is used as part of a cardioplegia system to set and maintain temperature for given flow rates and within the given temperature range of blood cardioplegic and crystalloid cardioplegic solutions during extracorporeal circulation. The product is designed for single use only, for an application period of no longer than 6 hours.
The MAQUET post-marketing vigilance program has identified a discrepancy that the desired cardioplegia temperature may not be obtained when the PLEGIOX Cardioplegia Heat Exchanger (PLEGIOX) is used in conjunction with a heater/cooler unit.
- 2014-03-19CPSCGanz USA LLC, Marietta, Ga.Ganz Recalls Grumpy Cat Stuffed Animal Toys Due to Choking Hazard
The stuffed animals' eyes can detach, posing a choking hazard to young children.
- 2014-03-19CPSCVera Bradley Designs Inc., of Fort Wayne, Ind.Vera Bradley Recalls Bear Ring Rattles and Bunny Toys Due to Choking Hazard
The pom-pom tail can detach from the body of the bear rattle and the bunny, posing a choking hazard to young children.
- 2014-03-12FDA-DeviceHeraeus Kulzer, LLC.Class IIBencoDental tartar & stain remover ultrasonic cleaning solution Product Usage: Formulated especially for removal of calculus, tartar, tobacco and food stains from dentures, bridges, orthodontic appliances, etc. Use also for removal of permanent cement.
As the result of a complaint to Heraeus Kulzer's customer service department, Heraues Kulzer is recalling Benco Tartar and Stain Solution part #1010-451, lot #13121434 because it has incorrect labeling on the immediate container. While the outer carton correctly states "Benco Tartar and Stain", the immediate gallon container in which the solution is contained incorrectly states "Benco Temporary C
- 2014-03-12FDA-DrugTeva Pharmaceuticals USAClass IITeva Ethambutol Hydrochloride Tablets, USP, 400 mg, 100- count bottle, Rx Only,Distributed by Teva Pharmaceuticals, USA, Sellersville, PA., NDC 0555-0923-02.
CGMP Deviations: Ethambutol Hydrochloride Tablets, USP, 400 mg were manufactured using unapproved material: the incorrect gelatin excipient than specified in the product formulation.
- 2014-03-07USDAClass IStop using George's chicken breast pieces
Misbranding, Unreported Allergens
- 2014-03-06CPSCDesign Ideas Ltd., of Springfield, Ill.Design Ideas Recalls Magnets Due to Risk of Ingestion
The small magnets can easily detach from the product. If swallowed, magnets can link together inside a child's intestines and clamp onto body tissues, causing intestinal obstructions, perforations, sepsis and death. Internal injury from magnets can pose serious lifelong health effects.
- 2014-03-05FDA-DeviceHologic, IncClass IINovaSure Impedance Controlled Endometrial Ablation System Radiofrequency Controller, Model Number: 71978-001 Catalog Number: RFC2009 Product Usage: The NovaSure Impedance Controlled Endometrial Ablation System is intended to ablate the endometrial lining of the uterus in premenopausal women with mehorrhagia (excessive bleeding) due to benign causes for whom childbearing is complete.
NovaSure Radiofrequency Control Units may not meet a requirement of the electrical standard, IEC 60601-1,
- 2014-03-05FDA-DeviceGE Healthcare, LLCClass IGE Healthcare - Giraffe¿ and Panda¿ iRes Infant Warmer Product Usage: The infant radiant warmers provide infrared heat in a controlled manner to neonates who are unable to thermo-regulate based on their own physiology. Infant radiant warmers may be used to facilitate the neonates transition to the external environment or to provide a controlled open environment. An optional integrated Sp02 monitoring feature may be used for continuous noninvasive monitoring of functional oxygen saturation
Oxygen and air wall inlet fittings on the back panel of the resuscitation systems were reversed during assembly.
- 2014-03-05FDA-DeviceGE Healthcare, LLCClass IGE Healthcare - Giraffe and Panda Bag and Mask Resuscitation System;Giraffe Stand-alone Infant Resuscitation System. Product Usage: The Bag and Mask Resuscitation System provides the basic equipment required for pulmonary resuscitation of infants. Pulmonary resuscitation includes practices necessary to establish a clear airway and provide oxygen or air/oxygen mixtures and/or manual ventilation to the infant. These are clinical practices that represent the established standard of care.
Oxygen and air wall inlet fittings on the back panel of the resuscitation systems were reversed during assembly.
- 2014-03-05FDA-DeviceGE Healthcare, LLCClass IGE Healthcare - Giraffe Warmer;Panda Warmer;Panda iRes Warmer, Giraffe Stand-alone Infant Resuscitation System. Product Usage: The T-Piece Resuscitation System [ventilator, emergency powered resuscitator]/Panda Bag and Mask Resuscitation System provides the basic equipment required for pulmonary resuscitation of infants. Pulmonary resuscitation includes practices necessary to establish a clear airway and provide oxygen or air/oxygen mixtures and/or manual ventilation to the infant. These ar
Oxygen and air wall inlet fittings on the back panel of the resuscitation systems were reversed during assembly.
- 2014-02-27CPSCRowe Fine Furniture Inc., of Elliston, Va.Rowe Fine Furniture Recalls Ottomans Due to Risk of Suffocation (Recall Alert)
Young children can become entrapped inside the storage compartment of the ottoman, posing a risk of suffocation.
- 2014-02-26FDA-DeviceSiemens Hearing Instruments, IncClass IISiemens Prisma 2K Hearing Aid Product Usage: A behind the ear (BTE) hearing aid developed for pediatric patients.
Siemens became aware of an issue where an infant or child could open the tamper resistant battery compartment of the Siemens Prisma 2K hearing aid under certain unintended use conditions.
- 2014-02-26FDA-FoodSTEMVIDA INTERNATIONAL INCClass ISTEMALIVE, 90 Capsules. The product is in a white plastic bottle with white lid, the brand is StemVida International with a white and gold label. Product labeling reads in part:"STEMVIDA INTERNATIONAL***StemAlive***PROMOTES ADULT STEM CELL FUNCTION AND HEALTH***Dietary Supplement***90 Capsules***Formulated exclusively for STEMVIDA International Corporation 4295 Jurupa St Ste 116, Ontario CA 91741***This exclusively formulated product is only available through ETEMVIDA International indepen
Stemvida International Corporation of Ontario California is recalling certain lots of StemAlive 90 Capsules, because it contains undeclared milk.
- 2014-02-26CPSCA Harvest Company, of Huntley, Ill.Cork Block Stacking Toys Recalled by A Harvest Company Due to Choking Hazard; Sold Exclusively at StorkStack.com
Small pieces of cork can break off the blocks, posing a choking hazard to young children.
- 2014-02-20CPSCThe Eastman Footwear Group Inc., of New York, N.Y.Eastman Footwear Recalls Coleman Runestone Children's Shoes
The metal rivets surrounding the holes where the shoestring is secured on the shoes can have sharp edges, posing a laceration hazard.
- 2014-02-20CPSCSamsung C&T America, Inc., New York, N.Y.U.S. Polo Assn. Recalls Girl’s Jacket Due to Strangulation Hazard
The jackets have a band of material at the neck that can pose a strangulation hazard to young children.
- 2014-02-20CPSCInfantino LLC, of San Diego, Calif.Infantino Recalls Teething Toys Due to Choking Hazard; Sold Exclusively at Target
The tail of the monkey can pose a choking hazard to young children.
- 2014-02-12FDA-DeviceElekta, Inc.Class IIXiO RTP System. Used to create treatment plans for any cancer patient for whom external beam radiation therapy or brachytherapy has been prescribed.
When bolus is present, the Effective Depth (with bolus) to the weight point returned on the Source Data Report is incorrect.
- 2014-02-12FDA-DeviceGE HealthcareClass IIUpgrade Kit, Resuscitation, T-Piece, part numbers M1139417, M1192226 and M1223628, labeled in part ***GE Healthcare 8880 Gorman Road Laurel, MD 20723 ***www.gehealthcare.com*** Provides the basic equipment required for pulmonary resuscitation of infants.
Medical device adjustment knob may be loose and affect the accuracy of blended Air/Oxygen gas mixture to patients.
- 2014-02-12FDA-DeviceGE HealthcareClass IIStand-Alone Resuscitation, T-Piece, part numbers 2063771-001, 2063772-001, 2063773-001, 2063774-001, 2063775-001, M1226442, M1241420, M1241421, M1241424, M1241425, M1241427, M1241430, M1241461, M1241463, M1241464, and M1241589; labeled in part ***GE Healthcare 8880 Gorman Road Laurel, MD 20723 ***www.gehealthcare.com*** Provides the basic equipment required for pulmonary resuscitation of infants.
Medical device adjustment knob may be loose and affect the accuracy of blended Air/Oxygen gas mixture to patients.
- 2014-02-12FDA-DeviceGE HealthcareClass IIStand-Alone Resuscitation Unit, Bag and Mask, Upgrade Kits, part number M1139612, labeled in part ***GE Healthcare 8880 Gorman Road Laurel, MD 20723***www.gehealthcare.com*** Provides the basic equipment required for pulmonary resuscitation of infant.s
Medical device adjustment knob may be loose and affect the accuracy of blended Air/Oxygen gas mixture to patients.
- 2014-02-12FDA-DeviceGE HealthcareClass IIStand-Alone Resuscitation Unit, Bag and Mask, part number M1226444, labeled in part ***GE Healthcare 8880 Gorman Road Laurel, MD 20723***www.gehealthcare.com***. Provides the basic equipment required for pulmonary resuscitation of infants.
Medical device adjustment knob may be loose and affect the accuracy of blended Air/Oxygen gas mixture to patients.
- 2014-02-12FDA-DeviceGE HealthcareClass IIPanda iRes¿ Infant Warmers, part number M1112198 and Panda Freestanding Warmers, part number 2063568, labeled in part *** GE Healthcare 8880 Gorman Road Laurel, MD 20723***www.gehealthcare.com** Panda Infant Warmers provide infrared heat in a controlled manner to neonates who are unable to thermo-regulate based on their own physiology.
Medical device adjustment knob may be loose and affect the accuracy of blended Air/Oxygen gas mixture to patients.
- 2014-02-12FDA-DeviceGE HealthcareClass IIGiraffe¿ Infant Warmers, part number M1118179, labeled in part *** GE Healthcare 8880 Gorman Road Laurel, MD 20723***www.gehealthcare.com* Giraffe¿ Infant Warmers provide infrared heat in a controlled manner to neonates who are unable to thermo-regulate based on their own physiology.
Medical device adjustment knob may be loose and affect the accuracy of blended Air/Oxygen gas mixture to patients.
- 2014-02-12FDA-DrugCentral Shared Services dba ParallonClass IICHILDREN'S IBUPROFEN, ORAL SUSPENSION, 200 mg/10mL cup BERRY FLAVOR, ALCOHOL FREE, MFG: ACTAVIS, PGK BY SAFECOR Columbus, OH
CGMP Deviation: Discoloration; Product fails specification for appearance/color. A complaint was received regarding an abnormal appearance of children's ibuprofen suspension.
- 2014-02-10NHTSA-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.
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