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.
- 2014-05-28FDA-DeviceFresenius Medical Care Holdings, Inc.Class INaturalyte Liquid Bicarbonate Concentrate, 6.4 Liter Bottle 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
Naturalyte Liquid Bicarbonate maybe contaminated
- 2014-05-28FDA-DeviceFisher & Paykel Healthcare, Ltd.Class IInfant Nasal CPAP (continuous positive airway pressure) Prong, Nasal. CPAP Prongs (10 pack): Model No. BC3020-10, BC3520-10, BC4030-10, BC4540-10, BC5040-10, BC5050-10, BC5550-10, BC5560-10, BC6060-10, BC6070-10, BC6570-10. Bubble CPAP Starter Kits: Model No. BC461-SK, BC471-SK, BC490-SK, BC491-SK, BC492-SK. The Nasal CPAP Prongs connect to the FPH FlexiTrunk Patient Interface.
The Infant Nasal CPAP Prong has the potential to detach from the Nasal Tubing and therapy is likely to be interrupted.
- 2014-05-28FDA-FoodStonyfield FarmClass IIStonyfield YoToddler Raspberry/Pear Cereal Organic Whole Milk Yogurt with Fruit and Cereal, multipack 6 pack plastic cups/4 oz each UPC-052159701215
Product has elevated levels of coliforms
- 2014-05-28FDA-FoodStonyfield FarmClass IIStonyfield YoBaby Vanilla Organic Whole Milk Yogurt multipack 6 pack plastic cups/4 oz each UPC-052159701178
Product has elevated levels of coliforms
- 2014-05-28FDA-FoodStonyfield FarmClass IIStonyfield YoBaby Pear/Peach Organic Whole Milk Yogurt multipack- 6 pack plastic cups- 3 peach and 3 pear/4 oz each cups UPC-052159701161
Product has elevated levels of coliforms
- 2014-05-28FDA-FoodH:20 Innovations LLCClass IIMeijer Baby Pediatric Electrolyte Strawberry Flavor 8oz x 4 with Best by: 10/02/15; 24 bottles per case, 6-4packs
H:20 Innovations is recalling Meijer Brand Baby Pediatric Electrolyte Fruit and Strawberry Flavor 8oz drinks due to a seal defect found during a complaint investigation.
- 2014-05-28FDA-FoodH:20 Innovations LLCClass IIMeijer Baby Pediatric Electrolyte Fruit Flavor 8oz x 4 with Best by: 10/01/15; 24 bottles per case, 6-4packs
H:20 Innovations is recalling Meijer Brand Baby Pediatric Electrolyte Fruit and Strawberry Flavor 8oz drinks due to a seal defect found during a complaint investigation.
- 2014-05-28FDA-DrugFresenius Medical Care Holdings, Inc.Class IIphosLo (calcium acetate) GelCaps, 667 mg, 200-count bottle, Rx only, Manufactured for Fresenius Medical Care North America, Waltham, MA 02451, NDC 0781-2081-02
Cross Contamination with Other Products: Potential for contaminant on the cotton packaging inside the bottle. Chemical analysis of the contaminant found on the cotton was identified as a formulation of 4% Trimipramine methanesulfonate - a tricyclic antidepressant..
- 2014-05-28CPSCHamilton Beach Brands Inc., of Glen Allen, Va.Hamilton Beach Recalls Baby Food Makers Due to Small Parts Hazard
Use of the slicing/shredding disc with the motor shaft adapter can cause the stainless steel pin in the food bowl lid to loosen and fall into processed food.
- 2014-05-27CPSCEmpress Arts Ltd. of Valencia, Calif.Children’s Pajamas Recalled by Empress Arts Due to Violation of Federal Flammability Standards
The pajamas fail to meet federal flammability standards for children's sleepwear, posing a risk of burn injuries to children.
- 2014-05-23USDAClass IDon't use Chaparros Mexican Foods beef products
Misbranding, Unreported Allergens
- 2014-05-22CPSCBosswin, of Shenzhen, ChinaLakeshore Learning Materials Recalls Bristle Builders for Toddlers Play Sets Due to Choking Hazard
The base of the three animal figures can detach, posing a choking hazard to young children.
- 2014-05-21FDA-DeviceRoche Diagnostics Operations, Inc.Class IIACCU-CHEK Compact Plus Test Strips For use with: ACCU-CHEK Compact Plus Meters; 17 count sample strip 51 count retail strip; 102 count retail strip; 51 count MedBen strip 51 count Mail Order strip; Sample Kit 16 per case. The ACCU-CHEK Compact Plus Test Strips are for use with the ACCU-CHEK Compact Plus Blood Glucose Meter to quantitatively measure glucose (sugar) in fresh capillary whole blood samples drawn from the fingertips or palm.
Roche Diabetes Care has become aware the ACCU-CHEK Compact Plus test strips may produce erroneously low blood glucose readings in patients undergoing Ceftriaxone therapy. The interference is not described in the product labeling.
- 2014-05-21FDA-DeviceNellcor Puritan Bennett Inc. (dba Covidien LP)Class IIRecalled product is a component of the Newport Medical Instruments e360 Ventilator: single board computer, part number SBC2105A. Intended to provide invasive or noninvasive ventilator support and monitoring for infant, pediatric, and adult patients with respiratory failure or respiratory insufficiency.
Reports of the audible alarm not sounding when the ventilator is in an alarm state. The ventilator, as well as the visual and remote alarms, continue to operate normally.
- 2014-05-21FDA-DeviceBaxter Corporation EnglewoodClass IABACUS TPN Calculation Software, Product Codes: 8300-0045 ABACUS CE (Calculator Edition), 8300-0046 ABACUS SE (Single-Workstation Edition), 8300-0047 ABACUS ME (Multi-Workstation Edition), 8300-0156 ABACUS 3.0 CE, 8300-0157 ABACUS 3.0 SE, 8300-0158 ABACUS 3.0 ME, 8300-0166 ABACUS 3.1 DE, 8300-0167 ABACUS 3.1 CE, 8300-0168 ABACUS 3.1 SE, 8300-0169 ABACUS 3.1 ME. ABACUS is a Windows - based order entry TPN software application for comprehensive calculations and label printing. The primary use of
1. ABACUS v3.1 may calculate quantities of electrolytes that are double the expected values during the creation of TPN orders. 2. ABACUS v3.1 may automatically add additional sterile water to a formula equal to the volume of a premix resulting in an over dilution. 3. All software versions of ABACUS software display the calcium phosphate curve points for Premasol incorrectly. 4. All software v
- 2014-05-21USDAClass IDo not eat recalled Wegmans or Sugar Lake Farms chicken strips
Misbranding, Unreported Allergens
- 2014-05-15CPSCSanta's Village Ind. Ltd., of Jinhua City, Zhejiang, ChinaNantucket Distributing Recalls Felt Easter Baskets Due to Choking Hazard
Decorative beads on the felt Easter baskets can detach and pose a choking hazard to young children.
- 2014-05-15CPSCH&M Hennes & Mauritz L.P., of North Arlington, N.J.H&M Recalls Girls’ Leggings Due to Choking Hazard
A metal part on the belt can detach, posing a choking hazard to young children.
- 2014-05-14FDA-DeviceMedtronic NeuromodulationClass IIMedtronic SynchroMed¿ II Implantable Drug Infusion Pump, Model 8637-20, 8637-40. The implantable Medtronic SynchroMed II programmable pumps are part of an infusion system that stores and delivers a prescribed drug to a specific site. The implanted infusion system consists of a SynchroMed II pump and a catheter.
This recall provides important new information regarding overinfusion associated with the Medtronic SynchroMed II Implantable Pump. Overinfusion can result in a life-threatening overdose and can also result in drug withdrawal due to premature emptying of the pump. Due to the low reported rate of occurrence of this issue and the inability to predict which pumps may be at risk, Medtronic is not re
- 2014-05-14FDA-DeviceGE HealthcareClass IIPanda¿ Wall-Mount Infant Warmers, integrated with Nellcor SpO2. Controlled infrared heat to neonates who are unable to thermo-regulate based on their own physiology with integrated monitoring feature used for continuous noninvasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate (measured by a SpO2 sensor).
Medical device software may be defective and may cause user-set alarm limits to result in false positive or false negative Oxygen saturation and pulse rate alarm notifications to the caregiver.
- 2014-05-14FDA-DeviceGE HealthcareClass IIPanda¿ Freestanding Infant Warmers, integrated with Nellcor SpO2. Controlled infrared heat to neonates who are unable to thermo-regulate based on their own physiology with integrated monitoring feature used for continuous noninvasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate (measured by a SpO2 sensor).
Medical device software may be defective and may cause user-set alarm limits to result in false positive or false negative Oxygen saturation and pulse rate alarm notifications to the caregiver.
- 2014-05-14FDA-DeviceGE HealthcareClass IIPanda¿ iRes Infant Warmers integrated with Nellcor SpO2. Controlled infrared heat to neonates who are unable to thermo-regulate based on their own physiology with integrated monitoring feature used for continuous noninvasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate (measured by a SpO2 sensor).
Medical device software may be defective and may cause user-set alarm limits to result in false positive or false negative Oxygen saturation and pulse rate alarm notifications to the caregiver.
- 2014-05-14FDA-DeviceGE HealthcareClass IIGiraffe¿ Infant Warmers integrated with Nellcor SpO2. Controlled infrared heat to neonates who are unable to thermo-regulate based on their own physiology with integrated monitoring feature used for continuous noninvasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate (measured by a SpO2 sensor).
Medical device software may be defective and may cause user-set alarm limits to result in false positive or false negative Oxygen saturation and pulse rate alarm notifications to the caregiver.
- 2014-05-07FDA-DrugP&L Developments, LLCClass IIIChildren's Triacting Night Time Cold & Cough with PE (diphenhydramine hcl and phenylephrine hcl), Grape Flavor, For Ages 6 to 11, 4 fl oz Bottles, liquid. Labeled A) aaron health KIDS, Manufactured by: Aaron Industries, P.O. Box 801, Lynwood, CA 90262. UPC: 7 15256 72204 9. B) FAMILY wellness, Distributed By: Family Dollar Services, Inc., 10401 Monroe Rd, Matthews, NC 28105. UPC: 0 32251 03394 0. C) Good Neighbor Pharmacy. Distributed By: AmerisourceBergen, 1300 Morris Drive, Chesterbrook, PA
Presence of Precipitate: Small amounts of diphenydramine and mannitol precipitated out of solution.
- 2014-05-07FDA-DrugCaraco Pharmaceutical Laboratories, Ltd.Class IIIChildren's Cetirizine Hydrochloride Chewable Tablets, 10 mg, 30 count bottle, OTC, Manufactured by Sun Pharma, Gujarat, India, Distributed Chain Drug Consortium, Boca Raton, FL, NDC 47335-344-83
Failed Impurities/Degradation Specifications: out of specification results for impurities/degradation testing for N-Oxide
- 2014-05-07FDA-DrugDeseo RebajarClass IAdipotrim XT, New Powerful Formula, 30 rapid release capsules per bottle, Dietary Supplement, www.adipotrim.com.
Marketed Without an Approved NDA/ANDA: FDA lab results found undeclared API Fluoxetine in this dietary supplement.
- 2014-05-07CPSCDiscount School Supply, of Monterey, Calif.Discount School Supply Recalls Sorting Boards Due to Magnet Ingestion Risk and Excessive Lead Levels (Recall Alert)
The magnet in the wand can detach and the plywood backing can crack and release small metal balls that are sandwiched between the board and a clear plastic cover. These pose choking and serious internal injury risks associated with ingestion of a magnet and metal ball. The surface paint on the metal balls contains levels of lead that exceed the federal lead paint standard.
- 2014-05-01CPSCJ. Crew Group Inc., of New York, N.Y.J. Crew Recalls Baby Coveralls Due to Choking Hazard (Recall Alert)
Snaps on the coveralls can detach, posing a choking hazard to young children.
- 2014-05-01CPSCRMP Athletic Locker Ltd., Ontario, CanadaRMP Athletic Locker Recalls Boys' Hooded Jackets; Drawstrings Pose Strangulation Hazard
The jackets have a drawstring around the neck area which poses a strangulation hazard to children. Drawstrings can become entangled or caught on playground slides, hand rails, school- bus doors or other moving objects, posing a significant strangulation and/or entanglement hazard to children.
- 2014-04-30FDA-DrugOhm Laboratories, Inc.Class IINon-Drowsy 24 Hour Formula Allergy Relief and Nasal Decongestant, Pseudoephedrine Sulfate, USP 240 mg , Loratadine, USP, 10 mg, 5, 10, 15 count blister packs, OTC Only. Labeled A) CVS Allergy Relief - D, Pseudoephedrine, USP 240 mg/Nasal Decongestant Loratadine, USP 10 mg/Antihistamine Extended Release Tablets, 5-count box Distributed by CVS Pharmacy Inc., One CVS Drive, Woonsocket, RI 02805 UPC 050428049631 B) Discount Drug Mart Non-Drowsy 24 Hour Formula Allergy Relief and Nasal Decongest
Defective Container: An unacceptable level of blister defects have been identified in Loratadine and Pseudoephedrine Sulfate Extended Release Tablets, 10 mg/240 mg.
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