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.
- 2021-07-14CPSCWalgreen Co., of Deerfield, Ill.Walgreens Recalls Disney Baby Winnie the Pooh Rattle Sets Due to Choking Hazard
The feet on the Winnie the Pooh rattle can detach, posing a choking hazard to young children.
- 2021-07-08CPSCCanyon Furniture Company, of Seffner, Fla.Canyon Furniture Recalls Creekside Children's Chests of Drawers Due to Tip-Over and Entrapment Hazards; Sold Exclusively at Rooms To Go (Recall Alert)
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.
- 2021-07-07CPSCShanghai Unitex Apparel, of Shanghai, ChinaOne Twenty Clothing Company Recalls "Sovereign Athletic" Children's Robes Due to Violation of Federal Flammability Standard and Burn Hazard
The children's robes fail to meet the federal flammability standards for children's sleepwear, posing a risk of burn injuries to children.
- 2021-07-01CPSCTBD Liquids LLC, of Santa Rosa, Calif.TBD Liquids Recalls Liquid Nicotine Products Due to Failure to Meet Child-Resistant Packaging Requirement; Risk of Poisoning (Recall Alert)
Liquid nicotine must be in special packaging as required by the Child Nicotine Poisoning Prevention Act (CNPPA). The packaging of the products is not child-resistant, posing a risk of poisoning if the contents are swallowed or touched by young children. Liquid nicotine is toxic if ingested or absorbed through the skin or eyes.
- 2021-06-30FDA-FoodDesigned by Nature LLCClass IDesigned by Nature Base Mix Formula: .375 oz/11 g plastic pouch/ Easy to Digest, Nutritionally Alive, Developed for All Life Stages. For the Little Ones in Your Life. UPC: 0 19962 28411 3 www.designed-by-nature.com
Products are deficient in multiple nutrients required for infant formula, and the firms contract manufacturer does not test for Cronobacter, a pathogen that can be particularly dangerous to infants and is sometimes found in powdered infant formulas.
- 2021-06-30FDA-FoodDesigned by Nature LLCClass IDesigned by Nature Goat's Milk Formula: Easy to Digest, Nutritionally Alive, Developed for All Life Stages. For the Little Ones in Your Life.
Products are deficient in multiple nutrients required for infant formula, and the firms contract manufacturer does not test for Cronobacter, a pathogen that can be particularly dangerous to infants and is sometimes found in powdered infant formulas.
- 2021-06-30FDA-FoodDesigned by Nature LLCClass IDesigned by Nature Cow's Milk Formula: 12 oz. plastic pouch. Easy to Digest, Nutritionally Alive, Developed for All Life Stages. For the Little Ones in Your Life. UPC: 0 19962 28421 2
Products are deficient in multiple nutrients required for infant formula, and the firms contract manufacturer does not test for Cronobacter, a pathogen that can be particularly dangerous to infants and is sometimes found in powdered infant formulas.
- 2021-06-30CPSCSIORO, of Wuhan, ChinaChildren's Robes Sold Exclusively on Amazon.com Recalled Due to Violation of Federal Flammability Standard and Burn Hazard; Manufactured by SIORO
The children's robes fail to meet the federal flammability standards for children's sleepwear, posing a risk of burn injuries to children.
- 2021-06-30CPSCMonahan Products, LLC, d/b/a UPPAbaby, of Hingham, Mass.UPPAbaby Recalls Adapters Included with RumbleSeats Due to Child Fall Hazard
The adapters can detach, posing a fall hazard to the child in the RumbleSeat.
- 2021-06-30CPSCBooph, of Shenzhen, ChinaChildren's Nightgowns Sold Exclusively on Amazon.com Recalled Due to Violation of Federal Flammability Standard and Burn Hazard; Manufactured by Booph
The nightgowns fail to meet the federal flammability standards for children's sleepwear, posing a risk of burn injuries to children.
- 2021-06-30CPSCAuranso Official, of Zhejiang, ChinaChildren's Nightgowns Sold Exclusively on Amazon.com Recalled Due to Violation of Federal Flammability Standard and Burn Hazard; Manufactured by Auranso Official
The nightgowns fail to meet the federal flammability standards for children's sleepwear, posing a risk of burn injuries to children.
- 2021-06-24CPSCLa Paloma, of Austin, TexasLa Paloma Recalls Girls' Nightgowns Due to Violation of Federal Flammability Standard; Burn Hazard (Recall Alert)
The recalled children's nightgowns fail to meet flammability standards for children's sleepwear, posing a risk of burn injuries to children.
- 2021-06-24CPSCPlant Guru, of Plainfield, N.J.Plant Guru Recalls Wintergreen, Birch and Blends of Essential Oils Due to Failure to Meet Child Resistant Packaging Requirement; Risk of Poisoning (Recall Alert)
The products contain the substance methyl salicylate which must be in child resistant packaging as required by the Poison Prevention Packaging Act (PPPA). The packaging of the products is not child resistant, posing a risk of poisoning if the contents are swallowed by young children.
- 2021-06-23FDA-DeviceMedivators, Inc.Class IIDialysate Concentrate for Hemodialysis-Liquid/Powd - Product Usage: used in conjunction with bicarbonate in a compatible artificial kidney (hemodialysis) machine.
The lot may have experienced an anomaly during the manufacturing process, that could lead to an out of specification concentrate formulation.
- 2021-06-16FDA-DeviceRAYSEARCH LABORATORIES ABClass IIRayStation (Treatment Planning System) Model Number RayStation is 6.0.0.24 , 6.1.1.2 , 6.2.0.7 , 6.3.0.6 , 7.0.0.19 , 8.0.0.6 , 8.0.1.10 , 8.1.0.47 , 8.1.1.8 , 8.1.2.5 , 9.0.0.113 , 9.1.0.933 , 9.2.0.483 , 10.0.0.1154 , 10.0.1.52 or 10.1.0.613 .
Evaluation of a clinical goal for the voxelwise worst dose distributions may be misleading after editing the clinical goal. It also describes an issue with contouring when the spacing between slices is d 1 mm, present in RayStation/RayPlan versions from 6 up to 10A.
- 2021-06-16FDA-FoodFaribault Foods, Inc.Class IIWhole Foods Market Organic Dark Red Kidney Beans, Net Wt 15.5 oz. (439g) UPC 99482-45272. Distributed by: Whole Foods Market, Austin, TX 78703
Undeclared allergens (wheat, soy, milk)
- 2021-06-10CPSCShantou Changxing Toy Industry Co. Ltd., of ChinaBlue Star Trading Recalls Children's Fishing Toy Games Due to Violation of Federal Lead Content Ban; Lead Poisoning Hazard; Sold Exclusively on Amazon.com (Recall Alert)
The metal rollers on the bottom of the flying dinosaur figures contain levels of lead that exceed the federal lead content ban. Lead is toxic if ingested by young children and can cause adverse health issues.
- 2021-06-09FDA-DeviceDraeger Medical, Inc.Class IICritical Care Ventilator, Catalog Number(s): 8422400: Babylog VN800 - Product Usage: used for treating patients who require temporary or longer term respiratory support for different medical reasons.
Three separate and unrelated problems attributed to the software used in the Evita V600, Evita V800, Babylog VN600 and Babylog VN800: 1. Restart of ventilation unit. 2. Incorrect FiO2 high and FiO2 low alarms. 3. SmartCare/PS (SC/PS) suspends weaning
- 2021-06-09FDA-DeviceDraeger Medical, Inc.Class IICritical Care Ventilator, Catalog Number(s): 8422200: Babylog VN600 - Product Usage: used for treating patients who require temporary or longer term respiratory support for different medical reasons.
Three separate and unrelated problems attributed to the software used in the Evita V600, Evita V800, Babylog VN600 and Babylog VN800: 1. Restart of ventilation unit. 2. Incorrect FiO2 high and FiO2 low alarms. 3. SmartCare/PS (SC/PS) suspends weaning
- 2021-06-09FDA-DeviceDraeger Medical, Inc.Class IICritical Care Ventilator, Catalog Number(s): 8422500: Evita V800 - Product Usage: used for treating patients who require temporary or longer term respiratory support for different medical reasons.
Three separate and unrelated problems attributed to the software used in the Evita V600, Evita V800, Babylog VN600 and Babylog VN800: 1. Restart of ventilation unit. 2. Incorrect FiO2 high and FiO2 low alarms. 3. SmartCare/PS (SC/PS) suspends weaning
- 2021-06-09FDA-DeviceDraeger Medical, Inc.Class IICritical Care Ventilator, Catalog Number(s): 8422300: Evita V600 - Product Usage: used for treating patients who require temporary or longer term respiratory support for different medical reasons.
Three separate and unrelated problems attributed to the software used in the Evita V600, Evita V800, Babylog VN600 and Babylog VN800: 1. Restart of ventilation unit. 2. Incorrect FiO2 high and FiO2 low alarms. 3. SmartCare/PS (SC/PS) suspends weaning
- 2021-06-03CPSCFisher-Price, of East Aurora, N.Y.Fisher-Price Recalls 4-in-1 Rock 'n Glide Soothers After Four Infant Deaths; 2-in-1 Soothe 'n Play Gliders Also Recalled
Infants who are placed unrestrained in the product and later found on their stomach are at risk of suffocation.
- 2021-06-02FDA-DeviceOrtho-Clinical Diagnostics, INc.Class IIVITROS CoV2 Ag calibrator (Product Code 6199950) - Product Usage: is a chemiluminescent immunoassay intended for the qualitative detection of SARS-CoV-2 nucleocapsid protein antigens in nasopharyngeal (NP) and anterior nasal swab specimens collected in CDCs formulation of VTM.
Ortho investigated and confirmed the potential for unexpected failed calibration, and condition codes associated with the calibration, when using VITROS SARS-CoV-2 Ag Reagent Pack along with VITROS Immunodiagnostic Products SARS-CoV-2 Ag Calibrator, Lot 20.
- 2021-06-02FDA-DeviceJames Leckey Design LtdClass IIMyWay Walker Chassis - Product Usage: is intended for use by children already using a supportive walking device.
Due to a failure of the welds, the casters detached from the rear legs of the walker.
- 2021-06-02FDA-DeviceRadiometer Medical ApSClass IIPIC070 Arterial Blood Sampler PICO70 - Product Usage: Preheparinized, electrolyte-balanced, arterial blood sampler product line for collection of arterial samples for pH, blood gas, oximetry, electrolyte and metabolite analysis. Model Number/Product Description: 956-518 PICO70 w/o needle; 956-519 PICO70 w/o needle; 956-522 PICO70 22G x 25 mm; 956-525 PICO70 22G x 32 mm; 956-529 PICO70 23G x 16 mm; 956-533 PICO70 23G x 25 mm; 956-534 PICO70 23G x 32 mm; 956-547 PICO70 25G x 16 mm;
Radiometer has become aware of an issue with PICO70 Arterial Blood Sampler. The issue relates to the sterile barrier system for the product. During internal stress testing on PICO70 Arterial Blood Samplers a breach in the sterile barrier system was observed in one sample. Risk for the patient: The described error is considered to have a remote possibility of resulting in bacterial bloodstream infection. The bloodstream infection may be asymptomatic but may also progress to sepsis or life-threatening septic shock. Immunosuppressed patients are at particular risk. Due to issues (breaches) with the sterile barrier system for the Arterial Blood Sampler.
- 2021-06-02USDAPublic Health AlertFSIS Issues Public Health Alert for Frozen Raw Breaded Stuffed Chicken Products Due to Possible Salmonella Contamination
Product Contamination
- 2021-06-02FDA-DrugCardinal Health Inc.Class IIChildren's Loratadine Oral Solution USP, 5 mg/5 mL (Antihistamine) Allergy Grape Flavor 4 FL OZ (120 mL) NDC 51672-2131-8 Distributed by: Taro Pharmaceuticals U.S.A., Inc. Hawthorne, NY 10532
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
- 2021-06-02FDA-DrugCardinal Health Inc.Class IIFerrous Sulfate 75 mg (equivalent to 15 mg Iron) Per 1.0 mL Alcohol 0.2% v/v Drops Iron Supplement Drops For Infants and Toddlers 50 mL (1 2/3 fl oz) NDC 54838-011-50 Manufactured by: Silarx Pharmaceuticals, Inc. 19 West Street Spring Valley, NY 10977 USA
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
- 2021-06-02FDA-DrugCardinal Health Inc.Class IIInfants Aqueous Vitamin D Oral Drops 400 IU/mL 50 mL (1 2/3 fl oz) Manufactrued by: Silarx Pharmaceuticals, Inc. 19 West Street Spring Valley, NY 10977 USA
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
- 2021-05-27CPSCWilliams Advanced Materials & Chemicals Inc., of Clairton, Pa.Williams Advanced Materials & Chemicals Recalls Three Chemical Products Due to Failure to Meet Child-Resistant Packaging Requirement and Violation of FHSA Labeling Requirement (Recall Alert)
The products Sodium Hydroxide, Heptane, or Naphtha must be in child resistant packaging, as required by the Poison Prevention Packaging Act (PPPA). The packaging of the products is not child resistant. The sodium hydroxide poses a risk of chemical burns and irritation to the skin and eyes. The heptane and naphtha pose a risk of eye, nose and throat irritation, headache, lightheadedness, dizziness, lack of coordination and loss of consciousness. In addition, the label on the products violates the Federal Hazardous Substance Act (FHSA) by omitting mandatory information on the packaging.
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