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.
- 2024-11-27NHTSA-EquipmentNuna Baby Essentials, Inc.Nuna Baby Essentials, Inc. — Front Harness Adjuster on Child Seat May Fail
In the event of a crash, the front harness may not restrain the child, increasing their risk of injury.
- 2024-11-21CPSCSouth Shore Industries LTD, of CanadaSouth Shore Cribs Recalled Due to Entrapment Hazard; Violation of Federal Regulation for Full Sized Cribs; Imported by South Shore Industries
The spacing between some of the crib's slats is wider than allowed under the federal safety standard, posing an entrapment hazard to children.
- 2024-11-21CPSCJingzhou Taike Sport Equipment Co. Ltd, of ChinaTodson Recalls Nerf Barrage Bicycle Helmets Due to Risk of Head Injury; Violation of Federal Regulations for Bicycle Helmets; Sold Exclusively at Walmart
The recalled helmets do not comply with the retention system requirements of the mandatory federal safety regulations for bicycle helmets. The helmets can fail to protect the wearer in the event of a crash, posing a risk of head injury.
- 2024-11-19NHTSA-EquipmentBritax Child Safety, Inc.Britax Child Safety, Inc. — Incorrect Maximum Weight on Labels/ FMVSS 213
An incorrect label and user guide may result in an improperly installed child seat, increasing the risk of injury in a crash.
- 2024-11-14CPSCStokke LLC, of Stamford, ConnecticutStokke Recalls YOYO³ Strollers Due to Injury Hazard
The parking brake on the recalled strollers can disengage, posing an injury hazard.
- 2024-11-14CPSCwoom Bike USA LLC, of Austin, Texaswoom Bikes USA Recalls Children's OFF, OFF AIR and ORIGINAL 6 Bicycles Due to Fall and Crash Hazards
The crank can break, due to fatigue fractures, causing the rider to lose control, posing fall and crash hazards.
- 2024-11-14CPSCPetidoux, of New YorkPetidoux Recalls Children's Pajamas Due to Burn Hazard; Violation of Federal Flammability Regulations for Children's Sleepwear
The recalled children's pajamas violate the flammability regulations for children's sleepwear, posing a risk of burn injuries to children.
- 2024-11-13FDA-DeviceBaxter Healthcare CorporationClass IIHillrom Welch Allyn XScribe Cardiac Stress Testing System; Programmable Diagnostic Computer
There is the potential for exam files being assigned duplicate Unique Identifiers (UIDs),. If the system receiving the DICOM file (e.g., Picture Archiving and Communication System (PACS)) relies solely on the UID to accept exams, this could lead to a mismatch of the patients identification with their physiological data.
- 2024-11-13FDA-DeviceBaxter Healthcare CorporationClass IIHillrom Welch Allyn RScribe 12-Lead Electrocardiograph System; Electrocardiograph
There is the potential for exam files being assigned duplicate Unique Identifiers (UIDs),. If the system receiving the DICOM file (e.g., Picture Archiving and Communication System (PACS)) relies solely on the UID to accept exams, this could lead to a mismatch of the patients identification with their physiological data.
- 2024-11-13FDA-DeviceBaxter Healthcare CorporationClass IIHillrom Welch Allyn HScribe Holter System; ambulatory monitoring
There is the potential for exam files being assigned duplicate Unique Identifiers (UIDs),. If the system receiving the DICOM file (e.g., Picture Archiving and Communication System (PACS)) relies solely on the UID to accept exams, this could lead to a mismatch of the patients identification with their physiological data.
- 2024-11-13FDA-DeviceDeRoyal Industries IncClass IIDeRoyal CHILDREN'S LAPTRACEPACK, 89-9362.06
DeRoyal is recalling certain lots of surgical procedure pack products that contain a Stryker SafeAir Smoke Evacuation Pencil. The recall is due to Stryker receiving reports that the pencil is activating without manual input when plugged into a power source or remains active after buttons are released.
- 2024-11-13FDA-DeviceDeRoyal Industries IncClass IIDeRoyal CHILDREN'S ORTHOPEDIC TRACEPACK, 89-9349-06
DeRoyal is recalling certain lots of surgical procedure pack products that contain a Stryker SafeAir Smoke Evacuation Pencil. The recall is due to Stryker receiving reports that the pencil is activating without manual input when plugged into a power source or remains active after buttons are released.
- 2024-11-13FDA-DeviceDeRoyal Industries IncClass IIDeRoyal CHILDREN'S GENERAL TRACEPACK, REF 89-9342-06
DeRoyal is recalling certain lots of surgical procedure pack products that contain a Stryker SafeAir Smoke Evacuation Pencil. The recall is due to Stryker receiving reports that the pencil is activating without manual input when plugged into a power source or remains active after buttons are released.
- 2024-11-13FDA-DrugDenison Pharmaceuticals, LLCClass IIIKids' Cough and Chest Congestion (Dextromethorphan HBr, USP 5mg/ Guaifenesin, USP 100 mg), packaged in 4 oz bottles further packaged in cartons, Distributed by: Genexa Inc., Alanta, GA, 30318, NDC-69676-0077-9, UPC Code# 850015736018
Crystallization: Lack of uniformity - a change in texture, chunky, grainy, and small crystal substances inside the bottles.
- 2024-11-07CPSCBaofali Trading Co. Ltd., dba Unique Person Home Goods, of ChinaBaofali Crib Bumpers Recalled Due to Suffocation Hazard; Violation of Federal Ban on Crib Bumpers; Sold Exclusively on Temu.com by Unique Person Home Goods
The recalled crib bumpers violate the federal crib bumper ban, posing a suffocation hazard to infants. Padded crib bumpers are banned by the federal Safe Sleep for Babies Act.
- 2024-11-07CPSCGuava Family Inc., of Solana Beach, CaliforniaGuava Family Recalls Roam Strollers Due to Fall and Injury Hazards
The stroller's brakes can fail to engage or unexpectedly disengage, posing fall and injury hazards to children.
- 2024-11-07CPSCKyte Baby, of South Lake, TexasKyte Baby Recalls Slumber Suits Due to Burn Hazard; Violation of Federal Flammability Regulations; Sold Exclusively on Kytebaby.com
The recalled slumber suits violate federal flammability regulations for children's sleepwear, posing a risk of burn injuries to children.
- 2024-11-07CPSCDreamGro Enterprises LLC, of New YorkDreamgro Recalls Lullaby Travel Soothers Due to Choking Hazard
The recalled toy's gold-colored soft star can detach, posing a choking hazard to young children.
- 2024-11-06FDA-DeviceSmith & Nephew IncClass IIsmith&nephew LEGION OXINIUM POSTERIOR STABILIZED NONPOROUS FEMORAL COMPONENT, SIZE 5N, RIGHT, NARROW, REF 71421275; Uncoated knee femur prosthesis, metallic
Complaint received indicating that a package contained a LEGION NARROW PS OXIN SZ 5N RIGHT implant instead of a GENESIS II POSTERIOR STABILIZED FEMORAL SIZE 5 LEFT as described on the product label.
- 2024-11-06FDA-DeviceSmith & Nephew IncClass IIsmith&nephew GENESIS II NONPOROUS POSTERIOR STABILIZED FEMORAL COMPONENT, SIZE 5 LEFT, REF 71421015; Uncoated knee femur prosthesis, metallic
Complaint received indicating that a package contained a LEGION NARROW PS OXIN SZ 5N RIGHT implant instead of a GENESIS II POSTERIOR STABILIZED FEMORAL SIZE 5 LEFT as described on the product label.
- 2024-11-06FDA-DeviceSmith & Nephew IncClass IIsmith&nephew LEIGON OXINIUM CONSTRAINED NONPOROUS FEMORAL COMPONENT, SIZE 4 LEFT, REF 71421164; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER
Complaint received indicating that a package contained a LGN OX CONSTRAINED FEM 3 LT implant instead of a LGN OX CONSTRAINED FEM 4 LT as described on the product label.
- 2024-11-06FDA-DeviceSmith & Nephew IncClass IIsmith&nephew LEIGON OXINIUM CONSTRAINED NONPOROUS FEMORAL COMPONENT, SIZE 3 LEFT, REF 71421163; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER
Complaint received indicating that a package contained a LGN OX CONSTRAINED FEM 3 LT implant instead of a LGN OX CONSTRAINED FEM 4 LT as described on the product label.
- 2024-11-06FDA-DeviceDATEX--OHMEDA, INC.Class IGE Healthcare Giraffe Incubator Carestation CS1, Infant Incubator. Model Numbers: 1) 2082844-002-01040417; 2) 2082844-002-01044956; 3) 2082844-002-01058424; 4) 2082844-002-01069017; 5) 2082844-002-01089666; 6) 2082844-002-01090474; 7) 2082844-002-01091269; 8) 2082844-002-01093489; 9) 2082844-002-01113262; 10) 2082844-002-01113711; 11) 2082844-002-01123085; 12) 2082844-002-01123918; 13) 2082844-002-01128966; 14) 2082844-002-01133042; 15) 2082844-002-01146447; 16)
Prior to current established manufacturing practices, higher levels of airborne formaldehyde exposure from newly manufactured incubators could be seen during clinical use that would rapidly decrease over a week. Affected customers were notified in June 2023 to run incubators for a week to potentially off gas any residual airborne formaldehyde. The general scientific consensus is that sensory irritation of the eyes is the most sensitive endpoint with respect to exposure to airborne formaldehyde and is the adverse effect clinically experienced at the lowest concentration.
- 2024-11-06FDA-DeviceDATEX--OHMEDA, INC.Class IGE Healthcare Giraffe Omnibed Carestation CS1, combination infant incubator and infant warmer. Model Numbers: 1) 2082844-001-01040418; 2) 2082844-001-01046784; 3) 2082844-001-01052324; 4) 2082844-001-01052572; 5) 2082844-001-01055337; 6) 2082844-001-01065693; 7) 2082844-001-01069008; 8) 2082844-001-01073750; 9) 2082844-001-01086553; 10) 2082844-001-01089393; 11) 2082844-001-01090414; 12) 2082844-001-01092632; 13) 2082844-001-01111482; 14) 2082844-001-01115741; 15)
Prior to current established manufacturing practices, higher levels of airborne formaldehyde exposure from newly manufactured incubators could be seen during clinical use that would rapidly decrease over a week. Affected customers were notified in June 2023 to run incubators for a week to potentially off gas any residual airborne formaldehyde. The general scientific consensus is that sensory irritation of the eyes is the most sensitive endpoint with respect to exposure to airborne formaldehyde and is the adverse effect clinically experienced at the lowest concentration.
- 2024-10-31CPSCSanven Technology Ltd., of Rancho Cucamonga, CaliforniaSanven Technology Recalls Vevor Baby Gates Due to Entrapment Hazard; Violation of Federal Regulations for Gates and Enclosures
The gates violate the federal safety regulations for expansion gates and expandable enclosures. A child's torso can fit through the opening between the gate slat and side wall, posing an entrapment hazard to children.
- 2024-10-30FDA-DeviceSmiths Medical ASD, Inc.Class IImedex TranStar KIDS KIT 10IN. CLOSED BLOOD SAMPLE KIT with 30cc/hr Flush Device 10/EA, Product Code REF MX9548
Due to a manufacturing defect, users may experience inaccurate pressure monitoring, an interruption in pressure monitoring, or an inability to zero the device due to either a leak within the TranStar Disposable Pressure Transducer or from a defect within the TranStar Disposable Pressure Transducer chip.
- 2024-10-30FDA-DeviceSmiths Medical ASD, Inc.Class IImedex TranStar KIDS KIT 7INCH CLOSED BLOOD SAMPLE KIT with 30cc/hr Flush Device 10/EA, Product Code REF MX9547
Due to a manufacturing defect, users may experience inaccurate pressure monitoring, an interruption in pressure monitoring, or an inability to zero the device due to either a leak within the TranStar Disposable Pressure Transducer or from a defect within the TranStar Disposable Pressure Transducer chip.
- 2024-10-30FDA-DeviceSmiths Medical ASD, Inc.Class IImedex TranStar KIDS KIT 34IN. CLOSED BLOOD SAMPLE KIT with 30cc/hr Flush Device 10/EA, Product Code REF MX9545
Due to a manufacturing defect, users may experience inaccurate pressure monitoring, an interruption in pressure monitoring, or an inability to zero the device due to either a leak within the TranStar Disposable Pressure Transducer or from a defect within the TranStar Disposable Pressure Transducer chip.
- 2024-10-30FDA-DeviceSmiths Medical ASD, Inc.Class IImedex TranStar KIDS KIT 31IN. CLOSED BLOOD SAMPLE KIT with 30cc/hr Flush Device 10/EA, Product Code REF MX9544
Due to a manufacturing defect, users may experience inaccurate pressure monitoring, an interruption in pressure monitoring, or an inability to zero the device due to either a leak within the TranStar Disposable Pressure Transducer or from a defect within the TranStar Disposable Pressure Transducer chip.
- 2024-10-30FDA-DeviceSmiths Medical ASD, Inc.Class IImedex TranStar KIDS KIT 19IN. CLOSED BLOOD SAMPLE KIT with 30cc/hr Flush Device 10/EA, Product Code REF MX9543
Due to a manufacturing defect, users may experience inaccurate pressure monitoring, an interruption in pressure monitoring, or an inability to zero the device due to either a leak within the TranStar Disposable Pressure Transducer or from a defect within the TranStar Disposable Pressure Transducer chip.
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