Baby and kids' product recalls
6681 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.
- 2012-07-24CPSCKolcraft Enterprises Inc., of Chicago, Ill.Kolcraft Recalls Contours Tandem Strollers Due to Fall and Choking Hazards
The front wheel assembly can break, posing a fall hazard to the child in the stroller. In addition, for strollers manufactured in January and February 2012, the nuts that hold the stroller's basket support screws in place can detach. Detached nuts can pose a choking hazard to young children.
- 2012-07-24CPSCPeg Perego USA Inc., of Fort Wayne, Ind.Peg Perego Recalls Strollers Due to Risk of Entrapment and Strangulation; One Child Death Reported
Entrapment and strangulation can occur, especially to infants younger than 12 months of age, when a child is not harnessed. An infant can pass through the opening between the stroller tray and seat bottom, but his/her head and neck can become entrapped by the tray. Infants who become entrapped at the neck are at risk of strangulation.
- 2012-07-19CPSCDowneast Concepts Inc., dba Backyard and Beyond, of Yarmouth, MaineChildren's Beach Chairs Recalled by Downeast Concepts Due to Laceration Hazard
The recalled children's beach chairs have exposed, sharp metal rivets, posing a laceration hazard.
- 2012-07-18FDA-DeviceAtom Medical CorporationClass IIDual Incu i, (Atom Infant Incubator Model 100) Atom Medical Corporation 3-18-15 Hongo, Bunkyo-Ku, Tokyo, Japan 113-0033 Usage: An incubator for infants.
There is a potential for the device's canopy to move unintentionally when using the incubator mode or radiant warmer mode.
- 2012-07-18FDA-FoodRhee Brothers IncorporatedClass IIClams, Frozen Boiled Baby, in shell, 10 oz packages, 24 pkgs/carton, item #20699K. UPC 081652 206996.
Frozen clams, product of S. Korea, may be contaminated with Norovirus.
- 2012-07-18CPSCPanline USA Inc., Northvale, N.J.Trampolines Recalled by Panline USA Due to Fall Hazard
The handlebar can break, causing a fall hazard.
- 2012-07-12CPSCOld NavyOld Navy Recalls Toddler Girl Aqua Socks Due to Slip and Fall Hazard
This style of Aqua Socks has less traction when worn on wet or smooth surfaces such as hardwood or tile, creating a slip and fall hazard.
- 2012-07-12CPSCArtsana USA Inc., of Lancaster, Pa.Chicco Polly High Chairs Recalled Due to Laceration Hazard
Children can fall on or against the pegs on the rear legs of the high chair, resulting in a bruising or laceration injury.
- 2012-07-11FDA-DeviceThayer Medical CorporationClass IIAirLife¿ MiniSpacer¿ MDI Dispenser Adapter. Dual-Spray MiniSpacer¿ Metered Dose Inhaler (MDI) Dispenser/Adapter with 15 mm connections. The 15 mm Dual Spray MiniSpacer¿ is a Metered Dose Inhaler (MDI) Dispenser. It is a non-sterile, single-use item, intended to dispense aerosolized medication into a breathing circuit or ancillary circuits. MINISPACER adapters are indicated for patients on a breathing circuit, for whom aerosol medication has been prescribed, in short and long term critical ca
Internal data identified a molding defect in the 15 mm O.D. / I.D. MiniSpacer meter dose inhaler (MDI) adapter that results in an incomplete fill of the aerosol dispensing pathway.
- 2012-07-11FDA-DeviceCarefusion 2200 IncClass IAirLife Isothermal Breathing Circuit Accessory - Infant Patient Y Connector; an Rx device for single patient use; 30 connectors per box; CareFusion, 22745 Savi Ranch Parkway, Yorba Linda, CA 92887 USA, Made in Mexico Respiratory breathing circuits are used with a ventilator when mechanical ventilation is administered to a patient.
The Y adapter within the breathing circuit may spontaneously crack, causing a leak in the closed ventilation system. This leak could lead to a decrease in the tidal volume delivered to the ventilated patient.
- 2012-07-11FDA-DeviceCarefusion 2200 IncClass IAirLife Isothermal Breathing Circuit, Infant Respiratory Circuit, Non-Heated; an Rx device for single patient use; CareFusion, 22745 Savi Ranch Parkway, Yorba Linda, CA 92887 USA, Made in Mexico Respiratory breathing circuits are used with a ventilator when mechanical ventilation is administered to a patient.
The Y adapter within the breathing circuit may spontaneously crack, causing a leak in the closed ventilation system. This leak could lead to a decrease in the tidal volume delivered to the ventilated patient.
- 2012-07-11FDA-DeviceCarefusion 2200 IncClass IAirLife Isothermal Breathing Circuit, Infant Respiratory Circuit, Heated; an Rx device for single patient use; CareFusion, 22745 Savi Ranch Parkway, Yorba Linda, CA 92887 USA, Made in Mexico Respiratory breathing circuits are used with a ventilator when mechanical ventilation is administered to a patient.
The Y adapter within the breathing circuit may spontaneously crack, causing a leak in the closed ventilation system. This leak could lead to a decrease in the tidal volume delivered to the ventilated patient.
- 2012-07-11FDA-FoodSR Rosati, IncClass IIRosati Cry Baby Sour Watermelon water ice, 6 fl oz
Product label does not declare FD&C Yellow #5
- 2012-07-11CPSCThe Troxel Company, of Moscow, Tenn.Troxel Recalls Flexible Flyer Swing Sets Due to Fall Hazard
The see saw seats can break away from the bolt fasteners during use, posing a fall hazard.
- 2012-07-04FDA-DevicePolymer Technology Systems, Inc.Class IIPTS Panels Creatinine test strips. PTS Panels Creatinine Test Strips are intended to measure creatinine in whole blood. Creatinine measurements are used in the diagnosis and treatment of renal (kidney) diseases and in the monitoring of renal dialysis. This system is intended for the professional use for accurately and reproducibly measuring creatinine in human whole blood obtained from a finger stick sample
During a routine product investigation, a creatinine sample with a value less than 1.0 mg/dl was tested on a version 2.60 CardioCek PA meter and the meter provided a result of 0.08mg/dl, which is not the reportable measuring range for the CardioChek PA meter for the creatinine assay.
- 2012-07-04FDA-DeviceStryker EndoscopyClass IIFormula Shaver Handpiece (with buttons); Formula 180 Shaver Handpiece (with button) Rx only, Made USA.: Stryker Endoscopy 5900 Optical Court San Jose, CA 95138 Components within the Crossfire System that provided abrasion, resection, debridement and removal of bone and soft tissue through the Formula Shaver and blade, and the ablation and coagulation of soft tissue, as well as hemostasis of blood vessels through its SERFAS Energy electrosurgical probe.
Stryker Endoscopy determined that there may not have been adequate determination of required routine checks to ensure accuracy and fitness for use of specific serial numbers of Formula and 180 Shaver Hand Control.
- 2012-07-03CPSCInnovage LLC, of Foothill Ranch, Calif.Innovage Recalls Discovery Kids Lamps Due to Fire and Burn Hazards
The placement of internal wires near the circuit board can cause electrical short-circuiting and sparking, posing a fire and a burn hazard to consumers.
- 2012-06-28CPSCRigo International Inc., of Los AngelesChildren's Lounge Pants and Boxers Recalled by Rigo International Due to Violation of Federal Flammability Standard
The pants and boxers fail to meet the federal flammability standards for children's sleepwear, posing a risk of burn injury to children.
- 2012-06-28CPSCIshtex Textile Products Inc. of Duluth, Ga.Children's Pajamas Recalled by Ishtex Textile Products Due to Violation of Federal Flammability Standard
The pajamas fail to meet the federal flammability standards for children's sleepwear posing a risk of burn injury to children. The garments were advertised and sold as children's sleepwear.
- 2012-06-28CPSCPajamaGram of Shelburne, Vt.PajamaGram Recalls Children's Pajamas Due to Violation of Federal Flammability Standard
The pajamas fail to meet the federal flammability standards for children's sleepwear, posing a risk of burn injury to children.
- 2012-06-27FDA-DeviceNatus Medical IncorporatedClass IIOlympic Cool-Cap System is intended to provide treatment for neonatal hypoxic-ischemic encephalopathy (HIE). The Cool-Cap is indicated for use in full term infants (more than 36 week gestational age) with clinical evidence of moderate to severe HIE. The device provides selective head cooling with mild systemic hypothermia to prevent or reduce the severity of neurologic injury associated with HIE. It is a selective head cooling system for treatment of neonatal hypoxic-ischemic encephalo
Olympic Cool-Cap Cooling Module's power supply failed during treatment. The power supply failure can happen without prior indication and results in the unavailability of the system to begin or continue cooling treatment.
- 2012-06-27FDA-DeviceNon-Invasive Monitoring Systems, Inc.Class IIUSA-002 Rev A brochure is a two sided tri-fold printed marketing brochure describing the approved labeling indications for use, precautions and general operational information of the Exer-Rest device, Models AT3800 and AT4700. Brochure: "EXER-REST***A patented, FDA registered, Acceleration Therapeutics device delivering Whole Body Periodic Acceleration to the user for symptomatic relief of a wide range of complaints***Whole Body Periodic Acceleration (WBPA)***WBPA is accomplished utilizi
Non-Invasive Monitoring Systems Inc (NIMS) is voluntarily recalling promotional materials which contain unsubstantiated direct and indirect claims.
- 2012-06-27FDA-DeviceNon-Invasive Monitoring Systems, Inc.Class IIUS-001 Rev A brochure is a two sided tri-fold printed marketing brochure describing the approved labeling indications for use, precautions and general operational information of the Exer-Rest device, Models AT3800 and AT4700. Ever-Rest US Brochure US-001 Rev A. Brochure: "***AT acceleration THERAPEUTICS***At Non-Invasive Medical Solutions (NIMS) we pride ourselves on being at the forefront of developing drug free wellness solutions coupled with accredited peer-reviewed clinical research.
Non-Invasive Monitoring Systems Inc (NIMS) is voluntarily recalling promotional materials which contain unsubstantiated direct and indirect claims.
- 2012-06-20FDA-DeviceBaxter Healthcare CorporationClass ISigma Spectrum VOLUMETRIC INFUSION PUMP, with or without Master Drug Library, Part Number 35700 -- Common/Classification Name: Infusion Pump -- Class 2 medical device -- SIGMA LLC, Medina, NY 14103 Product Usage: The Spectrum Infusion Pump is intended to be used for the controlled administration of intravenous fluids. These fluids may include blood, blood products or mixtures of pharmaceutical drugs for required patient therapy. The Spectrum is used in conjunction with legally marked intrav
Recall expansion; the infusion pumps have the potential to fail causing inaccurate flow conditions during use. These conditions range from back flow to free flow, which could result in over-infusion. Sigma's evaluation of subsequent complaints involving failed bearings indicated that the loss or degradation of bearing lubricant to be a more significant contributor to bearing failure than initially believed. Based upon the results of the analysis of these additional failures, Sigma determined that any bearings prior to the latest, improved design may be at risk for failure. Sigma decided to expand the recall of the Spectrum Infusion Pumps to include units manufactured from 1/18/2005 through 11/01/2010.
- 2012-06-20FDA-FoodJ&I TRADING GROUP, INC.Class IIFresh Baby Clam Meat Labels on outer styrofoam container; 200 g packages, 30 or 40 packages/case, refrigerated. Refrigerate after opening. Product arrived via Korean Air Cargo directly to consignees.
The shellfish was harvested from waters that may have been exposed to inadequate sanitation controls.
- 2012-06-20FDA-FoodTaylor Farms Retail, Inc.Class IPrivate Selections Organic Baby Spinach, 5 oz plastic clamshell, UPC 0-11110-91128-5; Marketside Baby Spinach Organic, 10 oz plastic clamshell, UPC: 6-8113132900-2
USDA collected a sample and performed random sample on Marketside Organic Baby Spinach lot code TFRS 130B16 Best of Used By 5-25-12. This product tested positive for Salmonella.
- 2012-06-14CPSCKolcraft Enterprises Inc., of Chicago Ill.Strollers Recalled by Kolcraft Due to Fingertip Amputation and Laceration Hazards
A child or consumer's finger can become caught in the opening formed when locking and unlocking the hinge mechanism which is used to adjust the handlebars on the strollers. This presents an amputation and laceration hazard to children and the adults handling the stroller.
- 2012-06-05CPSCEvenflo Inc., of Miamisburg, OhioEvenflo Recalls Convertible High Chairs Due to Fall Hazard
The activity tray on the high chair can unexpectedly detach and allow an unrestrained child to fall, posing a risk of injury to the child.
- 2012-05-30CPSCToys "R" Us Inc. of Wayne, N.J.Toys R Us Recalls Imaginarium Activity Center Due to Choking Hazard
The small wooden knobs attaching the xylophone keys to the end can detach, causing a choking hazard to young children.
- 2012-05-17CPSCAqua-Leisure Industries Inc., of Avon, Mass.Aqua-Leisure Recalls Children's Trampolines Due to Fall Hazard; Sold Exclusively at Toys "R" Us Stores
Metal fatigue can cause the handlebar to break away during use, posing a risk of laceration from exposed metal surfaces or other injury from a fall.
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