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.
- 2021-10-06FDA-DeviceConvaTec, IncClass IIDuoDERM Control Gel Formula Border Dressings 15x15cm (1x5pk)
Primary packaging labeling may be incorrect.
- 2021-10-06FDA-DeviceAtrium Medical CorporationClass IIAtrium Pneumostat Chest Drain Valve, Part Number 16100
The firm is revising the Indication for Use, Contraindications, Warnings, and Precautions, after the device was involved in the treatment of a preterm infant who later died.
- 2021-10-06FDA-DrugWashington Homeopathic Products, Inc.Class IIZTE 1015 Formula, Contents 1000 ml, For Manufacturing Use only, REMEDY: Argentum Nitricum 10X, Rhus Toxicodendron 10X, Aurum Metallicum 10X, Iris Versicolor 10X, Lycopodium Clavatum 10X, Zincum Muriaticum 13X, Chromium Sulphuricum 10X, Manganum Metallicum 10X, Dilution Alcohol 20%, Manufactured for Optimal Health Dimensions, Manufactured by: Washington Homeopathic Products 260 JR Hawvernale Way, Berkeley Springs, WV, 25411,
Out-of-specification test results obtained for identification testing based on HPTLC analysis.
- 2021-10-06FDA-DrugWashington Homeopathic Products, Inc.Class IIZTE 1013 Formula Antimicrobial - F&M , Contents 1000 ml, REMEDY: Bryonia Alba 10X, Antimonium Crudum 10X, Iodium 10X, Lycopodium Clavatum 10X, Pulsatilla 10X, Berberus Vulgaris 10X, Glycyrrhiza Clabra 10X, Condurango 10X, Ginco Biloba 10X, Chromium Sulphuricum 10X, Manganum Metallicum 10X, Zincum Muriaticum 13X, Dilution Alcohol 20%, WHP Homeopathic Medicine, For Manufacturing Use Only; Manufactured for Optimal Health Dimensions, Manufactured by: Washington Homeopathic Products 260 JR Hawvernal
Out-of-specification test results obtained for identification testing based on HPTLC analysis.
- 2021-10-06FDA-DrugWashington Homeopathic Products, Inc.Class IIZTE-1035 Formula, Antimicrobial Combination, Contents 1006 ml, REMEDY: Arsenicum Album 10X, Baptista Tinctoria 10X, Phosphorus 10X, Arnica Montana 10X, Bryonia Alba 10X, Antimonium Crudum 10X, Iodium 10X, Lycopodium Clavatum 10X, Pulsatilla 10X, Berberis Vulgaris 10X, Glycyrrhiza Clabra 10X, Condurango 10X, Ginco Biloba 10X, Zincum Muriaticum 13X, Chromium Sulphuricum 10X, Manganum Metallicum 10X, Alfalfa 3X, Dilution Alcohol 20%, Manufactured by: Washington Homeopathic Products 260 JR Hawvern
Out-of-specification test results obtained for identification testing based on HPTLC analysis.
- 2021-10-06FDA-DrugWashington Homeopathic Products, Inc.Class IIZTE-1034 Formula Antimicrobial Bowel. Contents 1000ml. WHP Homeopathic Medicine, For Manufacturing Use Only, REMEDY: Arsenicum Album 10X, Baptisia Tinctoria 10X, Pulsatilla 10X, Lachesis Mutus 11X, Rhus Toxicodendron 10X, Belladonna 7X, Colchicum Autumnale 5X, Aconitum Napellus 8X, Astragalus Menziesli 8X, Carbo Vegetabilis 8X, Chamomilla 3X, Hydrastis Canadensis 3X, Echinacea Angustifolia 12X, Pulsatilla 11X, Anas Barariae, Hepatis ET 60C, Anas Barariae, Hepatis ET 100C, Anas Barariae, Hepatis
Out-of-specification test results obtained for identification testing based on HPTLC analysis.
- 2021-10-06FDA-DrugWashington Homeopathic Products, Inc.Class IIZ-1070 Formula Anxioheal. Contents 1000ml 20% Alcohol. WHP Homeopathic Medicine, For Manufacturing Use Only, REMEDY:Causticum 30X, Conium Maculatum 8X, Conium Maculatum 12X, Crataegus Oxyacantha 12X, Crataegus Oxyacantha 30X, Ignatia Amara 24X, Lycopus Virginicus 12X, Phosphoricum Acidum 12X, Phosphoricum Acidum 24X, Rhus Toxicodendron 24X, Secale Cornutum 24X, Secale Cornutum 30X, Sepia 6X, Sepia 24X, Solanum Nigrum 30X, Zincum Valericanicum 8X, Zincum Valerianicum 12X, Dilution Alcohol 20%. M
Out-of-specification test results obtained for identification testing based on HPTLC analysis.
- 2021-10-06FDA-DrugWashington Homeopathic Products, Inc.Class IIZ-1050 Formula Hepatodetox. Contents 1000ml. WHP Homeopathic Medicine, For Manufacturing Use Only, REMEDY: Cholesterinum 10X, Avena Sativa 12X, Cynara Scolymos 12X, Phosphorus 12X, Oroticum Acidum 13X, Aesculus Hipposcastanum 24X, Carduus Marianus 24X, Chelidonium Majus 24X, Cimicifuga Racemosa 24X, Cinchona Officinalis 24X, Colocynthis 24X, Histaminum Hydrochloricum 24X, Lycopodium Clavatum 24X, Sulphur 24X, Tataxacum Officinale 24X, Veratrum Album 24X, Sepia 30X, Strontium Carbonicum 30X, Dilu
Out-of-specification test results obtained for identification testing based on HPTLC analysis.
- 2021-10-06FDA-DrugWashington Homeopathic Products, Inc.Class IIZ-1020 Formula. Contents 1000ml 20% Alcohol. WHP Homeopathic Medicine, For Manufacturing Use Only, REMEDY: Aurum Metallicum 10X, Baryta Carbonica 10X, Chromium Sulphuricum 10X, Crataegus Oxyacantha 10X, Digitalis Purpurea 10X, Manganum Metallicum 10X, Zincum Muriaticum 13X, Dilution Alcohol 20%. Manufactured for Optimal Health Dimensions. Manufactured by Washington Homeopathic Products, Inc. 260 JR Hawvermale Way, Berkeley Springs, WV, 25411.
Out-of-specification test results obtained for identification testing based on HPTLC analysis.
- 2021-10-06FDA-DrugWashington Homeopathic Products, Inc.Class IIZTE-1020 Formula. Contents 1000ml. WHP Homeopathic Medicine, For Manufacturing Use Only, REMEDY: Aurum Metallicum 10X, Crataegus Oxyacantha 10X, Baryta Carbonica 10X, Digitalis Purpurea 10X, Zincum Muriaticum 13X, Chromium Sulphuricum 10X, Manganum Metallicum 10X, Dilution Alcohol 20%. Manufactured for Optimal Health Dimensions. RX Only, Manufactured by Washington Homeopathic Products, Inc. 260 JR Hawvermale Way, Berkeley Springs, WV, 25411.
Out-of-specification test results obtained for identification testing based on HPTLC analysis.
- 2021-10-06FDA-DrugWashington Homeopathic Products, Inc.Class IIZ-107 Formula Soft Tissue Healing. Contents 1000ml. For Manufacturing Use Only, REMEDY: Amygdalus Persica 10X, Arnica Montana 10X, Bellis Perennis 10X, Chromium Sulphuricum 10X, Citrus Vulgaris 10X, Derris Pinnata 13X, Franciscea Uniflora 13X, Hamamelis Virginiana 10X, Manganum Metallicum 10X, Ruta Graveolens 10X, Sarsaparilla 10X, Zincum Muriaticum 13X, Dilution Alcohol 20%. Manufactured for Optimal Health Dimensi. RX Only, Manufactured by Washington Homeopathic Products, Inc. 260 JR Hawvermale
Out-of-specification test results obtained for identification testing based on HPTLC analysis.
- 2021-10-06FDA-DrugWashington Homeopathic Products, Inc.Class IIZTE-105 Formula Gentle Detoxing. Contents 1000 mL, RX Only, REMEDY: Bryoni Alba 10X, Chelidonium Majus 10X, Carduus Marianus 10X, Dolichos Pruriens 10X, Solidago Vigaurea 10X, Alfalfa 10X, Boldo 10X, Cynara Scolymus 10X, Zincum Muriaticum 13X, Chromium Sulphuricum 10X, Manganum Metallicum 10X, Dilution Alcohol 20%. WHP Homeopathic Medicine. For Manufacturing Use Only, Manufactured for Optimal Health Dimensi. Manufactured By: Washington Homeopathic Products, 260 JR Hawvermale Way, Berkeley Sprin
Out-of-specification test results obtained for identification testing based on HPTLC analysis.
- 2021-10-06CPSCElliptiGO Inc., of Solana Beach, Calif.ElliptiGO Recalls Arc Model Stand-Up Bicycles Due to Fall and Injury Hazards
The bicycle frame can break while riding, posing fall and injury hazards to the user.
- 2021-09-29FDA-DrugDuPont Nutrition USA, IncClass IAvicel RC-591 NF (MCC/Carboxymethylcellulose Sodium) NF, bulk powder, 80.0 KG drum, Manufactured by: DuPont Nutrition USA, Inc., 1301 Ogletown Road, Newark, DE 19711
Microbial Contamination of Non-Sterile Product: Out-of-specification results obtained for total aerobic microbial count (TAMC).
- 2021-09-29CPSCLuyuan Inc., of City of Industry, Calif.Luyuan Recalls Youth All-Terrain Vehicles (ATVs) Due to Crash Hazard and Violation of Federal ATV Safety Standard
The youth ATVs fail to comply with the requirements of the federal mandatory ATV safety standard, including maximum speed limitations and other mandatory safety requirements for vehicles intended for children under 10 years of age. ATVs that fail to meet the mandatory safety requirements pose a risk of serious injury or death to children.
- 2021-09-29CPSCVenom Motorsports, of CanadaVenom Motorsports Recalls Youth Model All-Terrain Vehicles (ATVs) Due to Crash Hazard and Violation of Federal Safety Standard; Sold Exclusively on VenomMotorsports.com
The Venom Motorsports youth model ATVs do not meet mandatory safety requirements, including speed restrictions, posing a risk of serious injury or death. The ATVs also were imported and distributed in the U.S. without a Consumer Product Safety Commission (CPSC)-approved ATV Action Plan, which includes safety requirements designed to protect users.
- 2021-09-23CPSCThe Boppy Company, of Golden, ColoradoThe Boppy Company Recalls Over 3 Million Original Newborn Loungers, Boppy Preferred Newborn Loungers and Pottery Barn Kids Boppy Newborn Loungers After 8 Infant Deaths; Suffocation Risk
Infants can suffocate if they roll, move, or are placed on the lounger in a position that obstructs breathing, or roll off the lounger onto an external surface, such as an adult pillow or soft bedding that obstructs breathing.
- 2021-09-22FDA-FoodOrganic By Nature, Inc.Class IPurim Health Products: EpiGenius Kids Creamy Chocolate; 630 Grams, individually packed pouches. Daily Superfoods. This high protein, whole-food blend is an excellent source of vitamins A, C, D and E and contains superfruits and superveggies, along with healthy fat, fiber and probiotics. UPC: 7 64934 04600 7 Distributed by Purim, 2610 Homestead Place, Rancho Dominguez, CA Mix approximately 3 tablespoons with 8-10 oz. of cold water. i. MCT powder as a whole is 6% of the formula (37
Product recalled due to undeclared milk in MCT powder used in manufacturing. Milk is not declared on the label. Product item #'s 4600-P65, 4600
- 2021-09-15FDA-DeviceCopan ItaliaClass IICOPAN FLOQSwabs, STERILE.EO, for drawing clinical samples. CE0123, for the following reference numbers REF:501CS01, Minitip, sterile Single Wrapped, Molded bp 80mm; REF: 20226, P/N 501CS01Q100, Minitip, Sterile, Single Wrapped, bp 60MM, BUNDLES OF 20 pcs; REF: 501CS01.Q20, P/N 1127700, Minitip Applicator Sterile Ind. wrapped., bp 60mm, bundles of 20; REF: 502CS01, Regular, Sterile single Wrapped, Molded bp 80mm; REF: 503CS01, Flexible, Sterile Single Wrapped, Molded bp 100mm; REF: 22
A sterility assurance level of 10-6 cannot be guaranteed due to intentional fraud and data integrity issues at the contract sterilizer, Steril Milano.
- 2021-09-15FDA-DevicePhilips North America LLCClass IIPhilips, HEARTSTART, INFANT/CHILD - SMART PADS CARTRIDGE, REF: M5072A, (0-8 YEARS)< 55 lbs / 25 kg, CE 0123, NON-STERILE, Rx only, UDI: (01) 00884838023758 for use with defibrillator
Infant/Child defibrillator pads contain incorrect labeling. This could lead to a delay in therapy, or delivery of lower energy than indicated for an adult patient
- 2021-09-09CPSCWiggle Ltd., of UKVitus 14 and Vitus 16 Kids Bikes Recalled Due to Crash Hazard; Imported by Wiggle (Recall Alert)
The bicycles have handbrakes but no footbrakes. Federal regulations require the bicycles be equipped with both handbrakes and footbrakes. Sidewalk bicycles with handbrakes, but no footbrakes, may present a risk of injury to young children who might not be able to stop the bicycles using handbrakes only.
- 2021-09-09CPSCJuratoys US Corp., of Millersburg, Pa.Juratoys Recalls Children's Shaving Toys Due to Violation of Federal Phthalate Ban
The brown trim of the shaving kit bags contains levels of a regulated phthalate that exceed the prohibition of specific phthalates. Banned phthalates are toxic if ingested by young children and can cause adverse health issues.
- 2021-09-08FDA-DrugGlobal Sanitizers LLCClass IIMEDICALLY MINDED Hand Sanitizer Gel, ANTIMICROBIAL FORMULA, (Ethyl Alcohol 70% v/v), 8 Fl OZ (236 mL) bottle, Manufactured by Asiaticon, S.A. de C.V. Conkal 62, Jardines del Ajusco, Tlalpan, Ciudad de Mexico, C.P. 14200. Distributed by SBL Brands, LLC Las Vegas, NV 89119 UPC: 6 76753 00420 8 ,
CGMP Deviations: lots and products of hand sanitizer are being recalled because they were manufactured under the same conditions as the product lot found to contain methanol.
- 2021-09-08FDA-DrugGlobal Sanitizers LLCClass IIMEDICALLY MINDED Hand Sanitizer Gel, ANTIMICROBIAL FORMULA, (Ethyl Alcohol 70% v/v), 8.5 FL OZ / 250 mL bottle, Made in Mexico, Distributed by SBL Brands, LLC Las Vegas, NV 89119. UPC: 6 76753 00359 1 ,
CGMP Deviations: lots and products of hand sanitizer are being recalled because they were manufactured under the same conditions as the product lot found to contain methanol.
- 2021-09-08FDA-DrugGlobal Sanitizers LLCClass IMEDICALLY MINDED Hand Sanitizer Gel, ANTIMICROBIAL FORMULA, (Ethyl Alcohol 70% v/v), 8.5 FL OZ / 250 mL bottle, Made in Mexico, Distributed by SBL Brands, LLC Las Vegas, NV 89119. UPC: 6 76753 00359 1
Chemical Contamination: FDA analysis found 1 lot of MEDICALLY MINDED Hand Sanitizer Gel, ANTIMICROBIAL FORMULA (ethyl alcohol 70%) to be below the label claim for ethanol content and to contain methanol.
- 2021-09-08FDA-DrugGlobal Sanitizers LLCClass IMEDICALLY MINDED Hand Sanitizer Gel, ANTIMICROBIAL FORMULA, (Ethyl Alcohol 70% v/v), 8 FL OZ (236 mL) bottle, Manufactured by Asiaticon, S.A. de C.V. Conkal 62, Jardines del Ajusco, Tlalpan, Ciudad de Mexico, C.P. 14200, Distributed by SBL Brands, LLC. Las Vegas, NV 89119. Made in Mexico UPC: 6 76753 00420 8,
Chemical Contamination: FDA analysis found 1 lot of MEDICALLY MINDED Hand Sanitizer Gel, ANTIMICROBIAL FORMULA (ethyl alcohol 70%) to be below the label claim for ethanol content and to contain methanol.
- 2021-09-08FDA-DrugGlobal Sanitizers LLCClass IIMEDICALLY MINDED Hand Sanitizer Gel, ANTIMICROBIAL FORMULA, (Ethyl Alcohol 70% v/v), 8.5 FL OZ (250 mL) bottle, Manufactured by Asiaticon, S.A. de C.V. Conkal 62, Jardines del Ajusco, Tlalpan, Ciudad de Mexico, C.P. 14200, Distributed by SBL Brands, LLC. Las Vegas, NV 89119. Made in Mexico UPC 6 76753 00414 7
CGMP Deviations: lots and products of hand sanitizer are being recalled because they were manufactured under the same conditions as the product lot found to contain methanol.
- 2021-09-08NHTSA-EquipmentDorel Juvenile GroupDorel Juvenile Group — Potential Head Injury With Lap Belt Use/FMVSS 213
If the seat is installed with only the lap belt, the child has an increased risk of injury in the event of a crash.
- 2021-09-02CPSCThe Step2 Company LLC, of Streetsboro, OhioStep2® Recalls StepUp Sidekick Learning Towers™ Due to Fall Hazard (Recall Alert)
The storage tray with cup holders and step can come loose from the tower, posing a fall hazard to the child.
- 2021-09-01FDA-FoodNew Dawn Nutrition, Inc.Class IIAssist and Amend Advanced Digestive Enzyme Formula, Dietary Supplement, 60 capsules per bottle, Manufactured for and distributed by New Dawn Nutrition Omaha, NE
Product contained undeclared milk, wheat, and soy.
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