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.
- 2012-09-05FDA-DeviceBaxter Healthcare Corp.Class IIIMini-Infuser Model 150XL Single Speed Infusion Pump, an Rx battery operated syringe infusion pump; Product Usage: These product codes includes refurbished units. Intended for the controlled rate delivery of small volume parental fluids as prescribed by a physician. Usage: The Mini-Infuser System is designed for controlled intermittent administration of intravenous medication.
Should a battery with the minimum contact diameter (.51 inches) be placed on the battery spring (.53 inches), an electrical circuit will not be completed and the Mini-Infuser will not operate. The reason being that the Mini-Infuser Battery Spring has a flat contact that measures .53 inches ¿.01 inches on the inner diameter of the spring coil. The IEC 60086-2 and ANSI 08 standards specify a minimum
- 2012-09-05FDA-FoodFresh Ideas Inc.Class ICosta Multiple Bean Salad 4.5 lbs Poly Tub (Item #01407) Black Beans (black beans, water. salt, calcium chloride, ferrous gluconate), Kidney Beans (kidney beans, water. salt, CaCI2), Black Eyed Peas(blackeye peas. water, sail. calcium chloride and disodium EDTA to preserve color). Chick Peas (chick peas, water, salt, EDTA to promote color retention), Italian Dressing (distilled vinegar. soy bean oil, water, com syrup, salt, onion, red bell pepper, xantham gum, spica and oleo resin paprika, ca
Products contain recalled Gill's Onions due to Listeria monocytogenes
- 2012-09-05FDA-FoodFresh Ideas Inc.Class ICalico bean Salad 5 lbs Poly Tub (Item #01409) packaged under Costa and Stop & Shop brand, Item T1407, C1407, 5 lb Poly Bag Black eye peas , water, salt, calcium chloride and disodium EDTA to preserve color), Chick Peas (cooked dried chick peas, water,salt), Kidney Beans (kidney beans, water. salt, CaCI2), Black Beans (black beans, water. salt, CaCI2, ferrous gluconate), Italian Dressing (distilled vinegar, soy bean oil, water, com syrup,salt. onion, red bell pepper, xantham gum. spice
Products contain recalled Gill's Onions due to Listeria monocytogenes
- 2012-09-05FDA-FoodFresh Ideas Inc.Class ICosta Four Bean Salad 4.50 lbs Poly Tub (Item #01385 Green Beans, Kidney Beans (kidney beans, water, salt, CaCI2), Chick Peas (chick peas. water. salt, EDTA to promote color retention), Black Eyed Peas (black eye peas, water, salt, calcium chloride and disodium EDTA to preserve color). White Onions, Red Peppers , Italian Dressing (distilled vinegar. soy bean oil. water, com syrup, salt, onion. red bell pepper. xantham gum, spice and oleo resin paprika, calcium disodium EDTA), Red Peppers
Products contain recalled Gill's Onions due to Listeria monocytogenes
- 2012-09-05FDA-DrugApotex Corp.Class IIIAzelastine HCl Nasal Solution, 0.1 %, 137 mcg/spray, 30 mL bottle (200 Metered Sprays), Rx only, Mfg by: Apotex Inc., Toronto, Ontario, Canada M9L 1T9, NDC 60505-0833-5.
CGMP Deviations: tubing used for filling may interact with the nasal formulation of this product.
- 2012-08-30CPSCMeijer Inc., of Grand Rapids, Mich.Meijer Stores Recalls Bicycles Due to Fall Hazard
Pedals on the bicycles can loosen or detach during use, posing a fall hazard to the rider.
- 2012-08-29FDA-DeviceGalil Medical, Inc.Class IIVisual-ICE¿ Cryoablation System, Model FPRCH 6000 Product Usage: The Galil Medical Visual-ICE Cryoablation System is intended for cryoablative destruction of tissue during minimally invasive procedures; various Galil Medical accessory products are required to perform these procedures. The Visual-ICE System is indicated for use as a cryosurgical tool in the fields of general surgery, dermatology, neurology (including cryoanalgesia), thoracic surgery, ENT, gynecology, oncology, proctology, and
Galil Medical is recalling a number of Visual Ice Cryoablation Systems because the gas regulators may fail to regulate the gas pressure, rendering the devices inoperable.
- 2012-08-29FDA-DrugVictus, Inc.Class IIHipoglos Ointment (zinc oxide and lanolin), Helps prevent and treat diaper rash, skin irritation, Manufactured by Laboratorios Andromaco S.A. Av. Quilin 5273, Penalolen, Santiago. www.hipoglos.cl, www.laboratoriosandromaco.cl, Made in Chile, Net wt. per Tube: a) 0.18 oz (5 g), NDC: 50145-111-05; b) 2.2 oz (60 g), NDC: 50145-111-04; c) 2.5 oz (72 g), NDC: 50145-111-03; d) 3.5 oz (100 g), NDC: 50145-111-02; e) 4.2 oz (120 g), NDC: 50145-111-01.
Misbranded
- 2012-08-29CPSCSummer Infant Inc., of Woonsocket, R.I.Summer Infant Recalls to Repair Baby Bathers Due to Fall and Head Injury Hazard Consumers should order free repair kit
When the bather is lifted and/or carried with an infant in it, its folding wire frame can suddenly disengage from the side hinge, dropping the baby out of the bather, posing a fall hazard and a risk of serious head injury to infants.
- 2012-08-23CPSCYi Wu Jiangyi Plastic Co., of ChinaCareBears Pacifier Recalled by IDM Group Due to Choking Hazard
The pacifiers fail to meet federal safety standards. The nipples can separate from the base, posing a choking hazard to young children.
- 2012-08-21CPSCMicro-Mobility Ltd., Kusnacht, SwitzerlandKickboard USA Recalls Children's Scooter Due to Laceration Hazard
The one-piece plastic platform that covers the front wheel base can break, posing a laceration hazard to children.
- 2012-08-20NHTSA-EquipmentBESI, Inc.BESI, Inc. — Aftermarket Child Restraint Systems
In the event of a crash, the seat occupant may not be properly restrained, possibly resulting in injury.
- 2012-08-16CPSCBabylicious Products Inc., of Vancouver, British Columbia, CanadaBabylicious Recalls Cloth Crib Fringe Due to Strangulation Hazard
The narrow fabric strip connecting individual fabric triangles presents a strangulation hazard to young children.
- 2012-08-15FDA-DeviceBaxter Healthcare Corp.Class IAUTOMIX 3+3 Compounder with Accusource Monitoring System, product 2M8287; automated nutrition compounders; Product Usage: The Automix Compounder Systems are electromechanical positive displacement fluid compounding devices used in the admixture of large volume parenteral nutrition formulations via gravimetric weighing.
After fluid ingress into the keypad of the AUTOMIX Compounder's (AUTOMIX) control module, the AUTOMIX may generate an incorrect device response to an AUTOMIX operator's key press. Also, the AUTOMIX system may experience an intermittent electrical failure, in which unexpected pump motor operations will occur. Also, the AUTOMIX system may intermittently experience an electrical failure where the compounder may stop compounding without an alarm and not be detected by the user.
- 2012-08-15FDA-DeviceBaxter Healthcare Corp.Class IAUTOMIX 3+3 Compounder System, product 2M8286 (115V) and 2M8286K (230V), automated nutrition compounders; Product Usage: The Automix Compounder Systems are electromechanical positive displacement fluid compounding devices used in the admixture of large volume parenteral nutrition formulations via gravimetric weighing.
After fluid ingress into the keypad of the AUTOMIX Compounder's (AUTOMIX) control module, the AUTOMIX may generate an incorrect device response to an AUTOMIX operator's key press. Also, the AUTOMIX system may experience an intermittent electrical failure, in which unexpected pump motor operations will occur. Also, the AUTOMIX system may intermittently experience an electrical failure where the compounder may stop compounding without an alarm and not be detected by the user.
- 2012-08-15FDA-DeviceBaxter Healthcare Corp.Class IAUTOMIX Plus High Speed Compounder System, product 2M8075; automated nutrition compounders; Product Usage: The Automix Compounder Systems are electromechanical positive displacement fluid compounding devices used in the admixture of large volume parenteral nutrition formulations via gravimetric weighing.
After fluid ingress into the keypad of the AUTOMIX Compounder's (AUTOMIX) control module, the AUTOMIX may generate an incorrect device response to an AUTOMIX operator's key press. Also, the AUTOMIX system may experience an intermittent electrical failure, in which unexpected pump motor operations will occur. Also, the AUTOMIX system may intermittently experience an electrical failure where the compounder may stop compounding without an alarm and not be detected by the user.
- 2012-08-15FDA-DeviceBaxter Healthcare Corp.Class IAUTOMIX High Speed Compounder System, product 2M8077; automated nutrition compounders; Product Usage: The Automix Compounder Systems are electromechanical positive displacement fluid compounding devices used in the admixture of large volume parenteral nutrition formulations via gravimetric weighing.
After fluid ingress into the keypad of the AUTOMIX Compounder's (AUTOMIX) control module, the AUTOMIX may generate an incorrect device response to an AUTOMIX operator's key press. Also, the AUTOMIX system may experience an intermittent electrical failure, in which unexpected pump motor operations will occur. Also, the AUTOMIX system may intermittently experience an electrical failure where the compounder may stop compounding without an alarm and not be detected by the user.
- 2012-08-15CPSCBumbo International Trust, of South AfricaBaby Seats Recalled for Repair by Bumbo International Due to Fall Hazard
Babies can maneuver out of or fall from the Bumbo seat, posing a risk of serious injuries.
- 2012-08-08FDA-DeviceBaxter Healthcare Renal DivClass IIExtraneal and/or DIANEAL LOW CALCIUM Peritoneal Dialysis Solution in Plastic Container, PL-146 used with Automated Peritoneal Dialysis System/Automated PD Set with Cassette; Manufactured for Baxter Healthcare Corporation, Deerfield, IL 60015 U.S.A. The HomeChoice dialysis system is a personal cycler automated peritoneal dialysis system for pediatric and adult renal patients with fill volumes ranging from 60 mL to 3000 mL. DIANEAL Low Calcium peritoneal dialysis solutions are indicated for us
Baxter discovered that a Baxter technical service representative was providing incorrect instructions for inspection of solution bags for a blocked frangible prior to connection to the Automated PD Set with Cassette.
- 2012-08-08FDA-DeviceSunrise Medical (US) LLCClass IIPadded Swing Away Arm Rest with Receiver; Uses on wheelchair models: Quickie Q7 (EIR4), GT (EIR3), GTi (EIT4) and Zippie Zone (EIRZ1). Product Usage: To empower physically challenged persons by providing a means of mobility. This includes temporary and permanent conditions.
Reports of injury when the Padded Swing Away Armrest is used for full body weight. Owner's manual states that armrest is only designed for resting of forearm.
- 2012-08-08FDA-FoodThe Wright Group dba Wright Enrichment, Inc.Class IWE-24541 Vit/Min Premix Toddler (1-4 yr old) w/o DHA*ARA, NET WEIGHT 22.68 KG
The product contains Galactooliosaccharide which was recalled due to possible salmonella contamination.
- 2012-08-08FDA-DrugAxcentria Pharmaceuticals LLCClass IIIMajor brand Infants' Mapap, Acetaminophen Concentrated Drops, 1 FL. OZ. (30 mL.) 80 mg. per 0.8 mL, Cherry Flavor, Distributed by MAJOR PHARMACEUTICALS, Livonia, MI --- NDC 0904-5255-30,
Labeling; labeled with incorrect EXP Date; Incorrect expiration date printed on the outer packaging. Package incorrectly states 5/2014 should correctly state 4/2014
- 2012-08-07CPSCMy Clothes Inc., of Montgomery, Ala.Children's Pajamas Recalled by My Clothes 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.
- 2012-08-01FDA-DeviceHill-Rom, Inc.Class IIAffinity Four Birthing Bed P3700 Product Usage: The Affinity, Four Birthing Bed is intended to be used as birthing beds for women of child bearing age in an LDR (Labor, Delivery, Recovery ) or LDRP (Labor, Delivery, Recovery, Postpartum) setting within the acute care Labor and Delivery market. They are not intended for use as general hospital beds.
During review of our last braking system via that field corrective action, the system still did not meet our expectations, which is to eliminate the hazards of patient falling. Bed movement immediately prior to, or during the birthing process may still create distractions and delays, resulting in patient or caregiver falls, or contribute to a deviation in a procedure, (e.g. IV insertion, epidural
- 2012-08-01FDA-FoodWellements, LLCClass IWellements Baby Move Prune Concentrate with Prebiotics, 4oz., 12 units per case, SKU# 141161, UPC 729609019878.
Wellements is recalling Wellements Baby Move Prune Concentrate, 4oz. because they have confirmed that their supplier of the ingredient galacto-oligosaccharide which is used in the Baby Move product may be contaminated Salmonella.
- 2012-08-01CPSCMidwest Folding Products, of Chicago, Ill.Stage and Riser Caddies Recalled by Midwest Folding Products Due to Risk of Injury or Death Child died when stage stored on caddy fell on her
The caddy's latches do not automatically close to secure the stages and risers when stored. Unsecured stages and risers can fall off the caddies and onto consumers.
- 2012-07-31CPSCGreen Toys Inc., of Mill Valley, Calif.Green Toys Recalls Mini Vehicles Due To Choking Hazard
The wheels and hubcaps on the toy cars can detach, posing a choking hazard to young children.
- 2012-07-31CPSCVAUDE Sport GmbH & Company KG, of GermanyLiberty Mountain Recalls VAUDE Kenta Child Carriers Due to Fall Hazard
The side strap's seam can unravel and cause the strap to separate, posing a fall hazard to the child in the carrier.
- 2012-07-25FDA-FoodNutri-Health Supplements Llc.Class IProbitotic Dietary Supplement. : iFlora¿ Kids Multi-Probiotic¿
On the evening of Friday, July 6, 2012, Ingredion, Inc. (f/k/a Corn Products U.S., Inc.) the supplier of Galactooligosaccharide (GOS), an ingredient included, in iFlora¿ Kids Multi Probiotic, notified our contract manufacturer that two lots of their GOS material supplied for inclusion in our products were being recalled for a suspected salmonella contamination. Although our contract manufacturer
- 2012-07-25FDA-FoodStandard Process, Inc.Class ISP Standard Process, Cataplex ACP (Product #0700 and 0750) , Dietary supplement, 90 & 360 Tablets, Proprietary Blend: Dried buckwheat ( leaf) juice, buckwheat (seed), carrot (root), calcium lactate, nutritional yeast, bovine adrenal, bovine kidney, alfalfa flour, dried alfalfa, (whole plant) juice, magnesium citrate, mushroom, bovine bone, Echinacea (root, deflated wheat, (germ), oat flour, soybean lecithin, yeast bone, calcium acid, phosphate, mixed tocopherols, (soy), rice (bran), and carrot
Standard Process, Inc. is voluntarily recalling 3 dietary supplements due to potential Salmonella contamination.
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