Baby and kids' product recalls
6719 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.
- 2021-11-10FDA-FoodKansas City LLC., DBA Best Harvest BakeriesClass IIHamburger buns, customer specified formula, in unlabeled clear plastic bags, 30 or 12 buns per bag.
Positive environmental samples analyzed for Listeria and Salmonella species.
- 2021-11-10CPSCABUS Mobile Security Inc., of Chicago, IllinoisABUS Recalls Youth Helmets Due to Risk of Head Injury
The recalled helmets do not comply with the U.S. CPSC federal safety standard for bicycle helmets, posing a risk of head injury.
- 2021-11-10USDAClass IThrow out Citterio salame sticks
Product Contamination
- 2021-11-04CPSCBackyard Play Systems LLC, of Monroe, MichiganBackyard Play Systems Recalls Playsets with Wooden Roof Due to Entrapment Hazard (Recall Alert)
The wooden parts used to reinforce and create a decorative gable design on the wooden roof pose an entrapment hazard to children. Children can become trapped in the gap between the lower part of the roof structure and the bottom of the gable decoration.
- 2021-11-03FDA-DrugUltra Seal CorporationClass IIIAdvance Formula Pain Reliever (Acetaminophen 250 mg/Aspirin 250 mg/Caffeine 65 mg) tablets, 2 tablets Per Packet, Packaged in 12,000 Packets/Case, PO# 007564-00, Item# 1170, Mfg. for: Advanced First Aid, Baltimore, MD 21237; American Safety & First Aid, Osceola, IN 46561 (Shipping Label)
Failed Stability Specifications: Out-of-Specification results observed for Aspirin related compound Salicylic Acid.
- 2021-11-03FDA-DrugUltra Seal CorporationClass IIIZEE+ painaid ESF Extra-Strength Formula (Acetaminophen 250 mg, Aspirin 250 mg (NSAID), Caffeine 65 mg) tablets, 2 Tablets per/package, Packaged in a) 50-count packages/carton, b) 125-count packages/carton, PA-ESF 1414Z, Dist. by: Zee Medical Distributors, LLC Mason, OH 45040 (Shipping Label)
Failed Stability Specifications: Out-of-Specification results observed for Aspirin related compound Salicylic Acid.
- 2021-10-29USDAPublic Health AlertDo not eat Citterio salame sticks
Product Contamination
- 2021-10-28CPSCDesign Within Reach Inc., of Stamford, Conn.Design Within Reach Recalls Arc Collection Furniture Due to Violation of the Federal Lead Paint Ban (Recall Alert)
Surface paint on the furniture contain levels of lead that exceed the federal lead paint ban, posing a risk of lead poisoning. Lead is toxic if ingested by young children and can cause adverse health effects.
- 2021-10-27FDA-FoodMaple Island Inc .Class IIParent's Choice Rice Baby Cereal. Stage 1, 4+ months. Fully Cooked. Just add Liquid. Net Wt 8 oz (227g) UPC 81131-08290. Distributed By: Walmart Inc., Bentonville, AR 72716.
Product contains elevated level of inorganic arsenic.
- 2021-10-27FDA-DrugBeiersdorf IncClass IICoppertone Pure & Simple baby 50 Sunscreen Spray (To Deliver) Zinc Oxide 24.08%, NET WT 5 OZ (142 g) can, Beiersdorf Inc., Wilton, CT 06897 UPC 0 72140 02881 7
cGMP Deviations
- 2021-10-27FDA-DrugBeiersdorf IncClass IICoppertone Pure & Simple kids 50 Sunscreen Spray (To Deliver) Zinc Oxide 24.08%, NET WT 5 OZ (142 g) can, Beiersdorf Inc., Wilton, CT 06897 UPC 0 72140 02882 4
cGMP Deviations
- 2021-10-27FDA-DrugBeiersdorf IncClass ICoppertone Pure & Simple baby 50 Sunscreen Spray (To Deliver) Zinc Oxide 24.08%, NET WT 5 OZ (142 g) can, Beiersdorf Inc., Wilton, CT 06897 UPC 0 72140 02881 7
Chemical contamination; presence of benzene
- 2021-10-27FDA-DrugBeiersdorf IncClass ICoppertone Pure & Simple kids 50 Sunscreen Spray (To Deliver) Zinc Oxide 24.08%, NET WT 5 OZ (142 g) can, Beiersdorf Inc., Wilton, CT 06897 UPC 0 72140 02882 4
Chemical contamination; presence of benzene
- 2021-10-27CPSCMagnussen Home Furnishings, Inc., of Riverside, Calif.Magnussen Home Recalls Nova Series 5-Drawer Chests Due to Tip-Over and Entrapment Hazards
The recalled chests are unstable if they are not anchored to the wall, posing tip-over and entrapment hazards that can result in death or serious injuries to children. The chests do not comply with the performance requirements of the voluntary industry standard ASTM F2057-19.
- 2021-10-20FDA-DeviceDraeger Medical, Inc.Class IIBabylog VN500 Ventilator with Installed CO2 Measurement Option-intended for the ventilation of neonatal patients from 0.4 kg (0.88 lbs) up to 10 kg (22 lbs) and pediatric patients from 5 kg (11 lbs) up to 20 kg (44 lbs) bodyweight. Catalog Number: 8417400
Software 2.51 and Lower with Installed CO2 Measurement Option, may result in Restart of the Ventilator, brief cessation of ventilation can occur and loss of PEEP for approx. 8 seconds
- 2021-10-13FDA-DeviceContamac Solutions, Inc.Class IINutrifill Scleral, Hybrid, and Gas Permeable (GP) Lens Insertion Solution, Physiologic Formula, Preservative Free, 35 Single-use 10ml ampoules (360ml), UDI:00850012123002
Contact lens solution may contain foreign material
- 2021-10-07CPSCJoovy Holding Co., of Dallas, TexasJoovy Recalls Zoom 360 Ultralight Jogging Strollers Due to Fall Hazard (Recall Alert)
The stroller's front wheel bearing can fail or detach, posing a fall and injury hazard.
- 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.
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