Baby and kids' product recalls
6726 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.
- 2020-06-24FDA-DeviceGE Healthcare, LLCClass IIGiraffe Incubator with installed Servo Oxygen module. Infant incubator.
Potential for certain Giraffe Incubators and Giraffe OmniBeds to deliver a different environmental oxygen level than what is displayed by the device, if a certain optional component referred to as the Servo Oxygen Module is installed.
- 2020-06-24FDA-DeviceGE Healthcare, LLCClass IIGiraffe OmniBed with installed Servo Oxygen module. Infant incubator and warmer.
Potential for certain Giraffe Incubators and Giraffe OmniBeds to deliver a different environmental oxygen level than what is displayed by the device, if a certain optional component referred to as the Servo Oxygen Module is installed.
- 2020-06-24FDA-DrugEco Lips IncClass IIEcoLips Sport Lip Balm, SPF 30, Avobenzone (5%), Octinoxate (10%), Octisalate (5%), Net Wt. 0.15 oz. (4.25g) tube, Eco Lips, Inc., Marion, IA 52302, UPC: 859623000030; 859623000177; 859623000573; Display UPC: 859623000092; 859623000108; 859623000139; 859623000146; 859623000184; 859623000535; 859623001037.
Superpotent Drug: The active ingredient, avobenzone, is used at 5% which is higher than the allowable 3% in the sunscreen formula per FDA sunscreen regulations.
- 2020-06-18CPSCModus Furniture, of Los Angeles, Calif.Modus Furniture Recalls Dressers Due to Tip-Over and Entrapment Hazards: In-Home Remedy May be Delayed Due to COVID-19 Restrictions; Keep Product Away from Children (Recall Alert)
The recalled dressers are unstable if the mirror is not installed, posing serious tip-over and entrapment hazards that can result in death or injuries to children. The dressers do not comply with one of the performance requirements of the U.S. voluntary industry standard (ASTM 2057-17). The tip-over restraint kits do not comply with the performance requirements of the U.S. voluntary industry standard (F3096-14).
- 2020-06-17FDA-DevicePhysio-Control, Inc.Class IIInfant Child Starter Kits, Part Number: 3202784-009, containing Infant/Child Reduced Energy Defibrillation Electrodes, for use with LIFEPAK 1000 defibrillator, LIFEPAK 500 defibrillator, and LIFEPAK CR Plus/EXPRESS defibrillator - Product Usage: intended to be used by personnel who are trained on the device operation and in basic life support or other physician-authorized emergency medical response system.
Packaging of infant child reduced energy electrodes was not properly sealed.
- 2020-06-17FDA-DevicePhysio-Control, Inc.Class IIInfant/Child Reduced Energy Defibrillation Electrodes, Part Number: 3202380-006, for use with LIFEPAK 1000 defibrillator, LIFEPAK 500 defibrillator, and LIFEPAK CR Plus/EXPRESS defibrillator - Product Usage: intended to be used by personnel who are trained on the device operation and in basic life support or other physician-authorized emergency medical response system.
Packaging of infant child reduced energy electrodes was not properly sealed.
- 2020-06-11CPSCDavina Wellness, of Mapleton, UtahDavina Wellness Recalls Wintergreen Essential Oil and Essential Oil Blend with Wintergreen 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.
- 2020-06-11CPSCBonnsu LLC, of Sausalito, Calif. doing business as MiniwareBonnsu Recalls Miniware Teething Spoons Due to Choking Hazard
The teething spoon can break in a child's mouth when being used as a teether, posing a choking hazard to infants.
- 2020-06-10FDA-DeviceOsteomed, LLCClass IIOSTEOVATION 10 CC IMPACT FORMULA. REF/UDI: 390-2110/ /00813845021092 - Product Usage: The product provides a bone void filler that is replaced by bone during the healing process.
Incorrect shelf-life for bone void filler kits; the product may not maintain its setting characteristics for the labeled shelf-life duration.
- 2020-06-10FDA-DeviceOsteomed, LLCClass IIOSTEOVATION 5CC IMPACTFORMULA. REF/UDI: 390-2105/00813845020085 - Product Usage: The product provides a bone void filler that is replaced by bone during the healing process.
Incorrect shelf-life for bone void filler kits; the product may not maintain its setting characteristics for the labeled shelf-life duration.
- 2020-06-10FDA-DeviceOsteomed, LLCClass IIOSTEOVATION 3CC IMPACTFORMULA. REF/UDI: 390-2103/00813845020078 - Product Usage: The product provides a bone void filler that is replaced by bone during the healing process.
Incorrect shelf-life for bone void filler kits; the product may not maintain its setting characteristics for the labeled shelf-life duration.
- 2020-06-10FDA-DeviceOsteomed, LLCClass IIOSTEOVATIONEX 3CC IMPACTFORMULA. REF/UDI: 390-0203/00813845020030 - Product Usage: The product provides a bone void filler that is replaced by bone during the healing process.
Incorrect shelf-life for bone void filler kits; the product may not maintain its setting characteristics for the labeled shelf-life duration.
- 2020-06-10FDA-DeviceOsteomed, LLCClass IIOSTEOVATIONEX 5CC IMPACTFORMULA. REF/UDI: 390-0205/00813845020047 - Product Usage: The product provides a bone void filler that is replaced by bone during the healing process.
Incorrect shelf-life for bone void filler kits; the product may not maintain its setting characteristics for the labeled shelf-life duration.
- 2020-06-10FDA-DeviceOsteomed, LLCClass IIOSTEOVATION 10CC INJECT FORMULA. REF/UDI: 390-2010/00813845020061 - Product Usage: The product provides a bone void filler that is replaced by bone during the healing process.
Incorrect shelf-life for bone void filler kits; the product may not maintain its setting characteristics for the labeled shelf-life duration.
- 2020-06-10FDA-DeviceOsteomed, LLCClass IIOSTEOVATION 5CC INJECT FORMULA. REF/UDI: 390-2005/00813845020054 - Product Usage: The product provides a bone void filler that is replaced by bone during the healing process.
Incorrect shelf-life for bone void filler kits; the product may not maintain its setting characteristics for the labeled shelf-life duration.
- 2020-06-10FDA-DeviceOsteomed, LLCClass IIOSTEOVATIONEX 5CC INJECT FORMULA. REF/UDI: 390-0005/00813845020023 - Product Usage: The product provides a bone void filler that is replaced by bone during the healing process.
Incorrect shelf-life for bone void filler kits; the product may not maintain its setting characteristics for the labeled shelf-life duration.
- 2020-06-10FDA-DeviceOsteomed, LLCClass IIOSTEOVATIONEX 3CC INJECT FORMULA. REF/UDI: 390-0003/00813845020016 - Product Usage: The product provides a bone void filler that is replaced by bone during the healing process.
Incorrect shelf-life for bone void filler kits; the product may not maintain its setting characteristics for the labeled shelf-life duration.
- 2020-06-10FDA-DeviceOsteomed, LLCClass IIOSTEOVATIONEX 2CC INJECT FORMULA. REF/UDI: 390-0002/00813845020009 - Product Usage: The product provides a bone void filler that is replaced by bone during the healing process.
Incorrect shelf-life for bone void filler kits; the product may not maintain its setting characteristics for the labeled shelf-life duration.
- 2020-06-10CPSCIsland Wear. Inc., of Ocean City, Md.Island Wear Recalls Strollers Due to Violation of Federal Stroller and Carriage Safety Standard; Fall and Choking Hazards
The recalled strollers violate the federal Carriages and Strollers Safety standard. The location of the restraint system creates a large gap between the restraint and the seat. The child can slip through the gap, posing a fall hazard. In addition, the covering on the grab bar can detach and expose foam, posing a choking hazard to children.
- 2020-06-04CPSCTim Trading LLC, of Rowland Heights, Calif.Tim Trading Recalls Emori Wintergreen Essential Oil Due to Failure to Meet Child Resistant Packaging Requirement; Risk of Poisoning (Recall Alert)
The product contains the substance methyl salicylate which must be in child resistant packaging as required by the Poison Prevention Packaging Act (PPPA). The packaging of the product is not child resistant, posing a risk of poisoning if the contents are swallowed by young children.
- 2020-06-04CPSCCapstone Holdings LLC, dba Simply Earth, of Waldo, Wis.Capstone Holdings Recalls Simply Earth Wintergreen Essential Oil Due to Failure to Meet Child Resistant Packaging Requirement; Risk of Poisoning (Recall Alert)
The product contains the substance methyl salicylate which must be in child resistant packaging as required by the Poison Prevention Packaging Act (PPPA). The packaging of the product is not child resistant, posing a risk of poisoning if the contents are swallowed by young children.
- 2020-05-27CPSCSanvall Enterprises Inc., of Doral, Fla.Sanvall Enterprises Recalls Rapid Alivio Pain Relieving Roll-On Due to Failure to Meet Child Resistant Packaging Requirement; Risk of Poisoning
The product contains the substance methyl salicylate which must be in child resistant packaging as required by the Poison Prevention Packaging Act (PPPA). The packaging of the product is not child resistant, posing a risk of poisoning if the contents are swallowed by young children.
- 2020-05-21CPSCHerman Miller Inc., of Zeeland, Mich.Herman Miller and Design Within Reach Recall Dressers and Cabinets Due to Tip-Over and Entrapment Hazards; Remedy May Be Delayed Due to COVID-19 Restrictions; Keep Product Away from Children (Recall Alert)
The recalled dressers and cabinets are unstable and can tip over if not anchored to the wall, posing serious tip-over and entrapment hazards that can result in death or injuries to children. The chests do not comply with the performance requirements of the U.S. voluntary industry standard (ASTM F2057-19).
- 2020-05-21CPSCViva Doria, Inc. of Redmond, Wash.Viva Doria Recalls Wintergreen Essential Oil Due to Failure to Meet Child Resistant Packaging Requirement; Risk of Poisoning (Recall Alert)
The product contains the substance methyl salicylate which must be in child resistant packaging as required by the Poison Prevention Packaging Act (PPPA). The packaging of the product is not child resistant, posing a risk of poisoning if the contents are swallowed by young children.
- 2020-05-20FDA-DeviceCook Inc.Class IIFormula 418 Renal Balloon-Expandable Stent, RPN FOR418-18-80-6-12, Order Number (GPN) G56611 Balloon-expandable stent made of 316L stainless steel with a slotted tube configuration. It is pre-mounted on an over-the-wire balloon catheter, which serves as the delivery system. The stent is positioned between two radiopaque marker bands, which are located inside the balloon at the proximal and distal tapers of the balloon.
The firm received complaints on five devices from one specific lot where the stent dislodged from the balloon delivery system prior to deployment. Use of affected product may lead to increased procedural time and additional intervention to remove a stent that dislodged within an unintended location.
- 2020-05-20FDA-DeviceStryker Medical Division of Stryker CorporationClass IIStryker Power-PRO TL cot-powered ambulance cot Model Number 6550 - Product Usage: is a powered wheeled stretcher that is intended to support and transport the entire body of a traumatized, ambulatory or non-ambulatory human patient (includes infants and adults).
Ambulance Cots may not meet crash test standard BS EN 1789
- 2020-05-20CPSCStargate Apparel, of New YorkBunz Kidz Children's Sleepwear Sets Recalled by Stargate Apparel Due to Violation of Federal Flammability Standard; Burn Hazard
The children's sleepwear sets fail to meet the federal flammability standard for children's sleepwear which requires sleepwear to be either snug-fitting or flame resistant, posing a risk of burn injuries to children.
- 2020-05-14CPSCOrganic Pure Oil, of Santa Ana, Calif.Organic Pure Oil Recalls Wintergreen Essential Oil Due to Failure to Meet Child Resistant Packaging Requirement; Risk of Poisoning; Sold Exclusively on Amazon.com (Recall Alert)
The product contains the substance methyl salicylate which must be in child resistant packaging as required by the Poison Prevention Packaging Act (PPPA). The packaging of the product is not child resistant, posing a risk of poisoning if the contents are swallowed by young children.
- 2020-05-14CPSCW8 Distributing dba Jade Bloom, of Draper, UtahW8 Distributing Recalls Jade Bloom Wintergreen and Birch Sweet 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.
- 2020-05-14CPSCAromatics International LLC, of Florence, Mont.Aromatics International Recalls Wintergreen Essential Oil Due to Failure to Meet Child Resistant Packaging Requirement; Risk of Poisoning (Recall Alert)
The product contains the substance methyl salicylate which must be in child resistant packaging as required by the Poison Prevention Packaging Act (PPPA). The packaging of the product is not child resistant, posing a risk of poisoning if the contents are swallowed by young children.
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