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.
- 2013-07-17FDA-FoodDel Monte Fresh Produce North America, IncClass I7 Eleven brand Strawberry/Kiwi/Mango, 6 oz., UPC 0-52548-51979-7
In cooperation with the FDA's warning to not consume mangoes from Agricola Daniella in Mexico, Del Monte Fresh Produce N.A., Inc, is initiating a voluntary recall of 1,600 bowls of fresh-cut mangoes distributed to retail outlets due to the potential risk that the mangoes may contain Salmonella. Salmonella is an organism which can cause serious and sometimes fatal infections in young children, frai
- 2013-07-17FDA-FoodDel Monte Fresh Produce North America, IncClass I7 Eleven brand Pineapple/Mango/Grape, 6 oz., UPC 0-52548-51986-5
In cooperation with the FDA's warning to not consume mangoes from Agricola Daniella in Mexico, Del Monte Fresh Produce N.A., Inc, is initiating a voluntary recall of 1,600 bowls of fresh-cut mangoes distributed to retail outlets due to the potential risk that the mangoes may contain Salmonella. Salmonella is an organism which can cause serious and sometimes fatal infections in young children, frai
- 2013-07-17FDA-FoodDel Monte Fresh Produce North America, IncClass ISeasonal Blend: Del Monte brand, 32 oz., UPC 7-17524-77604-4; 7 Eleven brand, 6 oz., UPC 7-17524-77647-1; 16 oz., UPC 7-17524-77647-1; Wal-Mart, 10 oz., UPC 7-17524-77815-4; 16 oz., UPC 7-17524-77603-7; 32 oz., UPC 7-17524-77604-4
In cooperation with the FDA's warning to not consume mangoes from Agricola Daniella in Mexico, Del Monte Fresh Produce N.A., Inc, is initiating a voluntary recall of 1,600 bowls of fresh-cut mangoes distributed to retail outlets due to the potential risk that the mangoes may contain Salmonella. Salmonella is an organism which can cause serious and sometimes fatal infections in young children, frai
- 2013-07-17FDA-FoodDel Monte Fresh Produce North America, IncClass IDel Monte brand Tropical Blend, 7 oz., Lot number 05262101; 16 oz., UPC 7-17524-77868-7
In cooperation with the FDA's warning to not consume mangoes from Agricola Daniella in Mexico, Del Monte Fresh Produce N.A., Inc, is initiating a voluntary recall of 1,600 bowls of fresh-cut mangoes distributed to retail outlets due to the potential risk that the mangoes may contain Salmonella. Salmonella is an organism which can cause serious and sometimes fatal infections in young children, frai
- 2013-07-17FDA-FoodDel Monte Fresh Produce North America, IncClass IDel Monte brand Tropical Fruit Bowl, 28 oz., UPC 7-17524-77651-8; 64 oz., UPC 7-17524-77834-5
In cooperation with the FDA's warning to not consume mangoes from Agricola Daniella in Mexico, Del Monte Fresh Produce N.A., Inc, is initiating a voluntary recall of 1,600 bowls of fresh-cut mangoes distributed to retail outlets due to the potential risk that the mangoes may contain Salmonella. Salmonella is an organism which can cause serious and sometimes fatal infections in young children, frai
- 2013-07-17FDA-FoodDel Monte Fresh Produce North America, IncClass IDel Monte brand Tropical Fruit Medley, 16 oz., UPC 7-17524-77649-5
In cooperation with the FDA's warning to not consume mangoes from Agricola Daniella in Mexico, Del Monte Fresh Produce N.A., Inc, is initiating a voluntary recall of 1,600 bowls of fresh-cut mangoes distributed to retail outlets due to the potential risk that the mangoes may contain Salmonella. Salmonella is an organism which can cause serious and sometimes fatal infections in young children, frai
- 2013-07-17FDA-FoodDel Monte Fresh Produce North America, IncClass IMango (Fresh Cut): Del Monte brand slices, 32 oz., UPC 7-62357-07532-1, 32 oz., UPC 7-17524 72503-5; 16 oz., UPC 7-17524-71902-7, 8 oz., UPC 7-17524-72506-7, UPC 7-17524-72506-6; Del Monte brand chunks, 7 oz., 7 Eleven brand chunks, 6 oz., UPC 0-52548-52070-0
In cooperation with the FDA's warning to not consume mangoes from Agricola Daniella in Mexico, Del Monte Fresh Produce N.A., Inc, is initiating a voluntary recall of 1,600 bowls of fresh-cut mangoes distributed to retail outlets due to the potential risk that the mangoes may contain Salmonella. Salmonella is an organism which can cause serious and sometimes fatal infections in young children, frai
- 2013-07-17CPSCSCS Direct Inc., of Milford, Conn.Thermobaby Bath Seats Recalled by SCS Direct Due to Drowning Hazard; Sold Exclusively at Amazon.com
The bath seats fail to meet federal safety standards, including the requirement for stability. Specifically, the bath seats can tip over, posing a risk of drowning to babies.
- 2013-07-17CPSC5 Star Kids Apparel, LLC dba Mecca 5 Star, of New York, N.Y.Boys’ Hooded Jackets Recalled by 5 Star Kids Apparel Due to Strangulation Hazard
The recalled jackets have drawstrings with toggles inside the bottom hem and neck area, posing a strangulation hazard to children.
- 2013-07-11NHTSA-EquipmentNissin Kogyo Co., LTDNissin Kogyo Co., LTD — ABS Modulator may Allow for Wheel Skid
A loss of ABS operation may result in the motorcycle wheels locking up during hard braking increasing the risk of a crash.
- 2013-07-10FDA-DeviceSurgical Instrument Service And Savings, Inc.Class II- Abrader Bur, Round (Aqua) 4.0mm Ref. 7205324 Lot 123270 - AcromioBlaster Burr (Brick Red) 5.5mm Ref. 7205669 Lot 122590, 122454, 122465, 122434, 122665 - AcromioBlaster Burr (Sage Green) 4.0mm Ref. 7205668 Lot 122590, 123270 - Acromionizer Bur, Barrel, (Mauve) 4.0mm Ref. 7205326 Lot 122609 - BoneCutter Blade, Full Radius, Series 3000 (Orange/Black) 5.5mm Ref. 7206010 Lot 122609 - CoolCut Bone Cutter (Blue/Orange) 3.8mm Ref. AR-8380BC Lot 122631 arthoscope - CoolCut Bone Cu
The seal which maintains a sterile barrier for reprocessed medical devices became compromised to the point where product may fall out of the pouch.
- 2013-07-03FDA-DeviceMedtronic NeuromodulationClass IMedtronic SynchroMed EL Programmable pumps, Models 8626, 8626L, 8627, 8627L, (The SynchroMed EL Pumps are supplied in 10 ml or 18 ml reservoir size.) Sterilized using ethylene oxide. The pump is part of an infusion system that stores and delivers a prescribed drug to a specific site. The drug is stored in the pump reservoir. Per a programmed prescription, the drug moves from the pump reservoir, through the pump tubing, catheter port, and catheter, to the infusion site. The SynchroMed II Progr
Medtronic Neuromodulation is providing Healthcare Providers with safety information and patient management recommendations related to the potential for electrical shorting internal to they SynchroMed infusion pump. An electrical short circuit in a feedthrough may present as a motor stall or low battery reset/alarm and lead to a loss of or reduction in therapy which may result in the return of und
- 2013-07-03FDA-DeviceMedtronic NeuromodulationClass IMedtronic SynchroMed II, Model 8637, (The SynchroMed II Pump is supplied in 20 ml or 40 ml reservoir size.) Sterilized using ethylene oxide. The pump is part of an infusion system that stores and delivers a prescribed drug to a specific site. The implantable components of the SynchroMed II infusion system include the pump, catheter,r and catheter accessories The SynchroMed II Programmable Pump is indicated when patient therapy requires the chronic infusion of drugs or fluids:
Medtronic Neuromodulation is providing Healthcare Providers with safety information and patient management recommendations related to the potential for electrical shorting internal to they SynchroMed infusion pump. An electrical short circuit in a feedthrough may present as a motor stall or low battery reset/alarm and lead to a loss of or reduction in therapy which may result in the return of und
- 2013-07-03FDA-DeviceMedtronic NeuromodulationClass IMedtronic SynchroMed EL Programmable pumps, Models 8626, 8626L, 8627, 8627L, (The SynchroMed EL Pumps are supplied in 10 ml or 18 ml reservoir size.) Sterilized using ethylene oxide. Product Usage: The pump is part of an infusion system that stores and delivers a prescribed drug to a specific site. The drug is stored in the pump reservoir. Per a programmed prescription, the drug moves from the pump reservoir, through the pump tubing, catheter port, and catheter, to the infusion site.
Medtronic is providing Healthcare Professionals with important safety information and patient management recommendations regarding the unintended delivery of drug during the priming bolus function for the SynchroMed implantable infusion pump. The unintended delivery of drug can contribute to patient overdose or underdose symptoms which may be clinically relevant.
- 2013-07-03FDA-DeviceMedtronic NeuromodulationClass IMedtronic SynchroMed II, Model 8637, (The SynchroMed II Pump is supplied in 20 ml or 40 ml reservoir size.) Sterilized using ethylene oxide. Product Usage: The pump is part of an infusion system that stores and delivers a prescribed drug to a specific site. The implantable components of the SynchroMed II infusion system include the pump, catheter, and catheter accessories. The SynchroMed II Programmable Pump is indicated when patient therapy requires the chronic infusion of the fo
Medtronic is providing Healthcare Professionals with important safety information and patient management recommendations regarding the unintended delivery of drug during the priming bolus function for the SynchroMed implantable infusion pump. The unintended delivery of drug can contribute to patient overdose or underdose symptoms which may be clinically relevant.
- 2013-07-03FDA-FoodEnzyme Formulations, Inc.Class IIEnzyme Solutions, A Dietary Supplement, Formula 29, 8 oz. (226.8g), UPC Code 697706041408. Distributed by: Enzyme Formulations, Inc., Madison, Wisconsin, 53719.
Enzymes Formulations Inc. is recalling Enzyme Solutions Formula 29 8 oz., lot 1225822 because of a labeling error at the manufacturing. This resulted in 10 jars incorrectly containing a Multiple Enzyme Powder.
- 2013-06-27CPSCEasy Aces, Inc. d/b/a Fred & Friends, of Cumberland, R.I.Fred & Friends Recalls Baby Rattles Due to Choking Hazard
The rattle's end cap can separate, releasing small parts, posing a choking hazard to small children.
- 2013-06-26FDA-DrugMission Pharmacal CoClass IIISodium Sulfacetamide 10% and Sulfur 5% Lotion, (NDC 42792-102-01), 25 g Manufactured for: Austin Pharmaceuticals, LLC, Wilmington, DE
Superpotent: Drug product active ingredients were formulated incorrectly (too high) with respect to the label strength.
- 2013-06-19FDA-DeviceOrthoPediatrics CorpClass II90 Degree Cannulated Infant Blade Plate 35mm x 5mm x 3 Hole Product Usage: The OrthoPediatrics Locking Cannulated Blade Plate System is intended for fixation of long bone fractures and osteotomies in all pediatric subgroups (except neonates) and in small stature adults. Specific indications include: intertrochanteric derotation and varus osteotomies, femoral neck and pertrochanteric fractures, intertrochanteric valgus osteotomies, proximal and distal tibial osteotomies and humeral fracture
Post Market Surveillance of the 90 degree Cannulated Infant Blade Plate indicated that there have been five reports concerning bending of the plate intra-operatively.
- 2013-06-19FDA-DeviceOrthoPediatrics CorpClass II90 Degree Cannulated Infant Blade Plate 30mm x 5mm x 3 Hole Product Usage: The OrthoPediatrics Locking Cannulated Blade Plate System is intended for fixation of long bone fractures and osteotomies in all pediatric subgroups (except neonates) and in small stature adults. Specific indications include: intertrochanteric derotation and varus osteotomies, femoral neck and pertrochanteric fractures, intertrochanteric valgus osteotomies, proximal and distal tibial osteotomies and humeral fracture
Post Market Surveillance of the 90 degree Cannulated Infant Blade Plate indicated that there have been five reports concerning bending of the plate intra-operatively.
- 2013-06-19FDA-DeviceOrthoPediatrics CorpClass II90 Degree Cannulated Infant Blade Plate 25mm x 5mm x 3 Hole Product Usage: The OrthoPediatrics Locking Cannulated Blade Plate System is intended for fixation of long bone fractures and osteotomies in all pediatric subgroups (except neonates) and in small stature adults. Specific indications include: intertrochanteric derotation and varus osteotomies, femoral neck and pertrochanteric fractures, intertrochanteric valgus osteotomies, proximal and distal tibial osteotomies and humeral fracture
Post Market Surveillance of the 90 degree Cannulated Infant Blade Plate indicated that there have been five reports concerning bending of the plate intra-operatively.
- 2013-06-19FDA-DeviceEmbla System LlcClass IIembla Embletta Gold (It functions as a Polysomnography Recorder and Ventilator Effort Recorder). The Embletta Gold is a battery operated device which records physiologic signals used in the diagnosis of sleep disorders. It is intended to be used for adult and pediatric (excluding neonatal and infant) studies. The recorder is not equiped with an alarm device and is not intended to be used as a life monitor. It may be used in a variety of configurations and the recording of physiologic signals
Calibration error for Embla Embletta Gold units calibrated through service center between June 15, 2012 to February 27, 2013. This calibration error could cause a clinician to over titrate the patient and prescribe a therapy pressure higher than is necessary.
- 2013-06-19FDA-FoodRio Queen Citrus, IncClass IThe product was originally distributed in a bulk container of 12/1 Dry Pints in boxes labeled "Karol" with the Lot No. "01W45" stamped in the upper, right-hand corner on the face of the box. The box states "Distributed by Interstate Fruit & Vegetable", which is an affiliated business of Rio Queen Citrus, Inc. These packages were distributed at the retail level between November 10th & November 19th, 2012. At the retail level, the tomatoes may have been packaged in an alternative container dependi
Rio Queen Citrus, Inc. of Mission, TX is recalling 840 cartons of 12/1 Dry Pints of Mexican cherry tomatoes in "Karol" brand boxes, 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. Healthy persons infected with Salmonella often e
- 2013-06-19FDA-DrugOLAAX InternationalClass IMAXILOSS Weight Advanced, 225 mg proprietary blend of herbs, supplied in 36 count capsules in Green & Blue Boxes, Formulated and distributed by Olaax Corp, Lakeland, FL
Marketed Without an Approved NDA/ANDA: product contains sibutramine, a previously approved FDA drug removed from the U.S. marketplace for safety reasons, making it an unapproved new drug.
- 2013-06-19CPSCKolcraft Enterprises Inc., of Chicago, Ill.Strollers Recalled by Kolcraft Due to Projectile Hazard
The inner tube of the tire on the stroller can rupture causing the wheel rim to fracture and fly off as a projectile, posing a risk of bodily injury and property damage.
- 2013-06-18CPSCChelsea & Scott Ltd., of Lake Bluff, Ill.Chelsea & Scott Recalls Idea Baby Bath Seats Due to Drowning Hazard; Sold Exclusively at Onestepahead.com
The bath seats fail to meet federal safety standards, including the requirements for stability. Specifically, the bath seats can tip over, posing a risk of drowning to babies.
- 2013-06-18CPSCLiberty Procurement Co. Inc., of Union, N.J.Buy Buy Baby Recalls Idea Baby Bath Seats Due to Drowning Hazard
The bath seats fail to meet federal safety standards, including the requirements for stability. Specifically, the bath seats can tip over, posing a risk of drowning to babies.
- 2013-06-18CPSCBeBeLove, of Pico Rivera, Calif.BeBeLove Recalls Baby Bath Seats Due to Drowning Hazard
The bath seats fail to meet federal safety standards, including the requirements for stability. Specifically, the bath seats can tip over, posing a risk of drowning to babies.
- 2013-06-11NHTSA-EquipmentCombi USA, Inc.Combi USA, Inc. — Child Restraint Webbing/FMVSS 213
In the event of a crash, a child may not be remain adequately secured, increasing the risk of injury.
- 2013-06-07CPSCAdobe, of San Jose, Calif.Adobe Recalls High-Powered Magnets Distributed with Promotional Materials Package (Recall Alert)
When two or more magnets are swallowed, they 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.
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