Baby and kids' product recalls
6672 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.
- 2016-02-18CPSCJ. Crew Group Inc., of New York, N.Y.J. Crew Recalls Girls' Coats Due to Choking Hazard (Recall Alert)
The buttons on the front of the coat can detach, posing a choking hazard to young children.
- 2016-02-17FDA-DeviceMerge Healthcare, Inc.Class IIRadSuite, a picture archive and communications system. Model Numbers Versions 5.30.0, 5.30.1, 5.30.2, 5.30.2 SB0344, 5.30.3, 5.30.4, 5.30.4 HF0418E, 5.30.5, 5.30.5 HF0404E, 5.30.5 HF0413E, 5.30.5 HF390E, 5.30.5 SB0368, 5.30.6, 5.30.6 HF0405E, 5.30.6 HF0406E, 5.30.7, 5.30.7 HF0429E, 5.30.7 HF0441E, 5.30.7 HF0446E, 5.30.7 HF0470E, 5.30.7 HF0473E, 5.30.8, 5.30.8 HF0477E, 5.30.8 HF0490E, 5.30.8 HF0495 SB0508E, 5.30.8 HF0495E, 5.30.8 HF0495E SB504E, 5.30.8 HF0550, 5.30.8 SB0485E, 5.30.8 SB0486E, 5.30
Potential incorrect Standardized Uptake Values (SUV) measurements in RadSuite.
- 2016-02-17FDA-DrugFagron, IncClass IISyrSpend SF, Suspending Base, a convenient, sweetened, sugar-free syrup-suspending vehicle specially formulated to assist in extemporaneous preparation of oral liquid dose forms, Rx Only, Shake Well, 4 L bottle, Manufactured by Fagron Inc., St. Paul, MN 55120, NDC 51552-1079-9.
Microbial Contamination of Non-Sterile Products: Syrspend SF and Syrspend SF Grape Flavor are being recalled due to the presence of yeast.
- 2016-02-17FDA-DrugFagron, IncClass IISyrSpend SF, Suspending Base, Grape Flavored, a convenient, sweetened, sugar-free syrup-suspending vehicle specially formulated to assist in extemporaneous preparation of oral liquid dose forms, Rx Only, Shake Well, 4 L bottle, Manufactured by Fagron Inc., St. Paul, MN 55120, NDC 51552-1167-9.
Microbial Contamination of Non-Sterile Products: Syrspend SF and Syrspend SF Grape Flavor are being recalled due to the presence of yeast.
- 2016-02-17FDA-DrugFagron, IncClass IISyrSpend SF, a convenient, sweetened, sugar-free syrup-suspending vehicle specially formulated to assist in extemporaneous preparation of oral liquid dose forms, Rx Only, Shake Well, 500 mL bottle, Manufactured by Fagron Inc., St. Paul, MN 55120, NDC 51552-1079-5.
Microbial Contamination of Non-Sterile Products: Syrspend SF and Syrspend SF Grape Flavor are being recalled due to the presence of yeast.
- 2016-02-11CPSCNuna Baby Essentials Inc., of Morgantown, Pa.Nuna Baby Essentials Recalls High Chairs Due to Fall Hazard
The arm bar can bend or detach during use, posing a fall hazard to children.
- 2016-02-10FDA-FoodThis Bar Saves LivesClass IIThis Kid Saves Lives Chocolate Chip UPC #10858497004097 UPC# 858497004090
This Bar Saves Lives is recalling This Kid Saves Lives Chocolate Chip because the product contains whey protein and does not identify milk.
- 2016-02-09CPSCClassic Characters Inc., of Quebec, CanadaClassic Characters Recalls Infant Booties Due to Choking Hazard; Sold Exclusively at Cracker Barrel Old Country Store
The pompoms at the tip of the toe can detach, posing a choking hazard to young children.
- 2016-02-04CPSCWWRD U.S. LLC, of Wall, N.J.Wedgwood Decorative Baby Rattles Recalled by WWRD Due to Choking Hazard
The ball bearings inside each side of the decorative rattle can be released, posing a choking hazard to young children.
- 2016-02-04CPSCKHS America of Mt. Juliet, Tenn.KHS America Recalls Children's Musical Instrument Due to Violation of Lead Paint Standard
The pink metal note bar on the glockenspiel may contain excessive levels of lead in the paint, violating the federal lead paint standard. If the paint is scraped off and ingested lead can cause adverse health effects.
- 2016-02-03FDA-DrugPerrigo Company PLCClass IIGuaifenesin DM Cherry liquid (guaifenesin 100 mg/5 mL and Dextromethorphan HBr 5 mg/5 mL), packaged in 4oz. bottles, co-packaged with a dosing cup in a carton and sold under the following: a) Sunmark, Children's Mucus Relief Cough, Guaifenesin 100 mg/Expectorant, Dextromethorphan HBr 5 mg/Cough Suppressant, Cherry Flavor, 4 FL OZ (118 mL) Bottle, Alcohol Free, Gluten Free, Distributed by: McKesson, San Francisco, CA 94104, NDC 49348-828-34; b) Rite-Aid, Children's Mucus Relief Cough, Guaifenesin
Defective Delivery System: Firm recalled Guaifenesin liquid and Guaifenesin DM liquid due incorrect dose markings on the dosing cups.
- 2016-02-03FDA-DrugPerrigo Company PLCClass IIGuaifenesin Grape liquid 100 mg/5 mL, packaged in 4oz. bottles, co-packaged with a dosing cup in a carton and sold under the following: a) H.E.B. Mucus Relief, Children's Guaifenesin, Expectorant, Age 4+, Grape Flavor, Gluten Free, Alcohol Free, 4 FL OZ (118 mL) Bottle, Made for: H.E.B. San Antonio, TX 78204, NDC 37808-288-26; b) CVS, Children's Mucus Relief Chest Congestion, Guaifenesin, Expectorant, Alcohol free, Gluten free, 4 FL OZ (118 mL) Bottle, For Ages 4 to 12 Years, Grape Flavor Liquid
Defective Delivery System: Firm recalled Guaifenesin liquid and Guaifenesin DM liquid due incorrect dose markings on the dosing cups.
- 2016-02-02NHTSA-EquipmentGraco Children's Products, Inc.Graco Children's Products, Inc. — Incorrect Position of Reclining Label/FMVSS 213
If the instructions are followed as shown, a rear-facing infant could be placed in an upright position and/or a forward-facing toddler could be placed in a recline position. Either scenario may increase the risk of injury to the child in the event of a crash.
- 2016-01-21CPSCMindware Corp., of Omaha, Neb.Chillafish Recalls Children's Balance Bikes Due to Laceration Hazard (Recall Alert)
Overinflated tires can cause the wheel rims to crack and send pieces of the plastic rim flying, posing a laceration hazard to consumers.
- 2016-01-21CPSCBritax Child Safety Inc., of Fort Mill, S.C.CPSC, NHTSA and Britax Announce Recall of Infant Car Seats Due to Fall Hazard
The car seat carry handle can crack and break allowing the seat to fall unexpectedly, posing a risk of injury to the infant.
- 2016-01-21CPSCBritax Child Safety Inc., of Fort Mill, S.C.Britax Recalls Strollers and Replacement Top Seats Due to Choking Hazard
The foam padding on the stroller's arm bar can come off in fragments if the child bites the arm bar, posing a choking hazard.
- 2016-01-20FDA-DeviceMercury Enterprises, Inc. dba Mercury MedicalClass IIMercury Medical Neo-Tee T-Piece Resuscitator and T-Piece Circuit. The Neo-Tee T-Piece Resuscitator is a gas powered emergency resuscitator intended to provide emergency respiratory support by means of a face mask or a tube inserted into a patient's airway. It is intended for use with neonates and infants weighing less than 10kg (22 lb). The T-piece resuscitator circuit is a component used in conjunction with the T-piece resuscitator devices
Incorrect use of T-Piece resuscitators will result in complete occlusion of the patient circuit and consequent failure to ventilate the patient.
- 2016-01-20FDA-DeviceBoston Scientific CorporationClass IIBoston Scientific, PROPONENT" MRI DR Pacemakers, REF L211. These devices treat bradycardia (slow heartbeats) with RA and/or RV pacing therapy as necessary.
The literature packet packaged with the devices incorrectly describes the pacemaker as SR when it is actually a DR pacemaker or DR when it is actually a SR pacemaker.
- 2016-01-20FDA-DeviceBoston Scientific CorporationClass IIBoston Scientific, MRI PROPONENT" SR , REF L210 Pacemaker. These devices treat bradycardia (slow heartbeats) with RA and/or RV pacing therapy as necessary
The literature packet packaged with the devices incorrectly describes the pacemaker as SR when it is actually a DR pacemaker or DR when it is actually a SR pacemaker.
- 2016-01-19CPSCWalt Disney Parks and Resorts, of Lake Buena Vista, Fla.Walt Disney Parks and Resorts Recalls Infant Bodysuits Due to Choking Hazard
The snaps on the bodysuits can detach, posing a choking hazard to young children.
- 2016-01-14CPSCSchool Specialty Inc., of Greenville, Wis.School Specialty Expands NeoRok Stools Recall Due to Fall Hazard (Recall Alert)
The stool can break during use, posing a fall hazard.
- 2016-01-13FDA-DeviceEthicon, Inc.Class IIGynecare Thermachoice III Uterine Balloon Therapy System Ethicon, Inc. The GYNECARE THERMACHOICE¿ III Uterine Balloon Therapy (UBT) System is a thermal balloon ablation device intended to ablate the endometrial lining of the uterus in pre-menopausal women with menorrhagia (excessive uterine bleeding) due to benign causes for whom childbearing is complete.
Stability data does not substantiate the labeled two-year shelf life of affected product.
- 2016-01-12CPSCPier 1 Imports of Fort Worth, TexasPier 1 Imports Recalls Swingasan Chairs and Stands Due to Fall Hazard
The suspension hardware on the chair and stand can break, or the stand can become unstable during use, posing a fall hazard.
- 2016-01-08NHTSA-EquipmentBritax Child Safety, Inc.Britax Child Safety, Inc. — Carry Handle May Crack and Fracture
If the seat falls, there is an increased risk of injury to the infant in the child restraint.
- 2016-01-07CPSCZulily Inc., of SeattleZulily Recalls Children's Pajamas Due to Violation of Federal Flammability Standard (Recall Alert)
The pajamas do not meet the federal flammability standards for children's sleepwear, posing a risk of burn injuries.
- 2016-01-06FDA-DeviceElekta, Inc.Class IIMOSAIQ Oncology Information System 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 wherever radiotherapy and/or chemotherapy are prescribed.
Incorrect drug dosage due to "Age Limit" and patient weight data item issue.
- 2016-01-06FDA-FoodPure Source, Inc.Class IIBaker's Best Maximum Mind & Memory Formula, 60 capsules, Vitamin B6 75 mg. Distributed by Baker's Best Health Products, Inc. Wixom, MI
Vitamin B6 level below percent declared on label
- 2016-01-06FDA-DrugWalgreens Infusion ServicesClass II3-in-1 TPN formula daily+overfill Bag, 2000 mL, Rx Only, Compounded by Option Care 148, San Antonio, TX 78232-5045
Lack of Assurance of Sterility
- 2015-12-30FDA-DevicePhilips Electronics North America CorporationClass IICardinal Health Tiny Toes; 11470-010T Infant heel warmer
Heel warmers may cause first and second degree burns.
- 2015-12-30FDA-DeviceDraeger Medical, Inc.Class IOptional PS500 Power Supply Unit for the Evita V500 Ventilator and Babylog VN500 Ventilator. Babylog VN500 is a ventilation unit intended for the ventilation of neonatal and pediatric patients.
The firm became aware of cases in which the battery run times of the optional PS 500 power supply unit with the Infinity Workstation Critical Care (Evita Infinity V 500) were unexpectedly short due to the design of the charging algorithm in the current software. Devices used for patient transport will be a priority.
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