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.
- 2021-08-11FDA-FoodGrimmway Enterprises, Inc. dba Grimmway FarmsClass IOrganic Peeled Baby-Cut Carrots Brand name: O Organics 1 lb. (454 g) plastic bag UPC: 0 7989340850 7 12 oz. packages - O Organics. Did not reach retail. Destroyed at DC's 12 oz. packages - Bunny Luv - Did not reach retail. Destroyed at DC's 12 oz. packages - HEB - Did not reach retail. Destroyed at DC's 12 oz. and 1 lb. packages - Market Basket. Did not reach retail. Destroyed at DC's 12 oz. and 1 lb. packages - Greenwise. Did not reach retail, Destroyed at DC's 1 lb. packages- Pur
Carrot products may be contaminated with Salmonella
- 2021-08-11FDA-FoodGrimmway Enterprises, Inc. dba Grimmway FarmsClass IOrganic Cut and Peeled Baby Carrots Brand name: Bunny Luv 1 lb.(454 g) plastic bag UPC: 0 3338390205 0;
Carrot products may be contaminated with Salmonella
- 2021-08-11CPSCShanghai One Top Corporation, of Shanghai, Chinadormakaba Recalls Delayed Egress Locks Due to Risk of Entrapment in an Emergency
The lockset can fail to open, posing an entrapment hazard and inability to vacate a location in an emergency.
- 2021-08-04FDA-DeviceSunrise Medical (US) LLCClass IIZippie Voyage, early intervention stroller - Product Usage: is manually operated by a caregiver for purposes of assisting a disabled person while providing supportive elements for assisted transportation and seating for a child or small adult not to exceed 75 pounds.
The seating system unexpectedly detached, which resulted in the seating system falling to the ground, causing injury.
- 2021-08-04FDA-DeviceSunrise Medical (US) LLCClass IIZippie Voyage, early intervention stroller - Product Usage: is manually operated by a caregiver for purposes of assisting a disabled person while providing supportive elements for assisted transportation and seating for a child or small adult not to exceed 75 pounds.
The seating system unexpectedly detached, which resulted in the seating system falling to the ground, causing injury.
- 2021-08-04FDA-DeviceHill-Rom, Inc.Class IIAffinity Four Birthing Bed-used as a birthing bed for women of child bearing age in an LDR (Labor, Delivery, Recovery) or LDRP (Labor, Delivery, Recovery, Postpartum) setting within the acute care Labor and Delivery market Model Numbers: P3700B, P3700C, P3700D, & P3700E
Latch mechanism on the Lift-Off foot section of the Affinity Four Birthing Bed is damaged, it could potentially cause the installed foot section to be improperly engaged onto the bed, could result in injury to the user due to a fall.
- 2021-08-04FDA-DeviceIon Beam Applications S.A.Class IIProteus 235-Proton Therapy System
if the user forgets to select the trigger input manually while beam gating is prescribed for the patient, the proton irradiation will be delivered without gating. If the beam is not gated as prescribed, the treatment field may be delivered with an error in position
- 2021-08-04FDA-FoodOld Souls Farms LLCClass IOld Souls Farm Green Bibb 2 lbs, 5 oz, Living Heads clamshells - 1oz 18 per case, 5oz 6 per case bulk bags - 1lb is 3 per case, 10lbs 1 per case, 25lbs 1 per case living are packed in plastic sleeves - 10 per case
Positive rainwater test for Listeria monocytogenes. The rainwater came in contact with product.
- 2021-08-04FDA-FoodRandall Foods, Inc.Class IIRANDALL KIDNEY BEANS 48OZ glass jars UPC 070095000308; RANDALL KIDNEY BEANS 24OZ glass jars UPC 070095000315; RANDALL KIDNEY BEANS 15.4OZ glass jars UPC 070095000339
Lack of functioning Temperature Indicating Devices in retorts
- 2021-07-29CPSCPuning Han Huini, of ChinaChildren's Sleepwear Recalled Due to Violation of Federal Flammability Standard and Burn Hazard; Sold Exclusively by Zoetop Business Co. Ltd. at www.SHEIN.com (Recall Alert)
The recalled sleepwear sets fail to meet flammability standards for children's sleepwear, posing a risk of burn injuries to children.
- 2021-07-29USDAClass IDo not use Greater Omaha Packing raw beef
Product Contamination
- 2021-07-28FDA-DeviceCardinal Health 200, LLCClass IIInfant Heel Warmer without Attachment Tab, Nonsterile, Active Product SKU MH00002N The infant heel warmer is activated at the point of care by squeezing the pouch. This mixes the substrates inside the pouch causing an exothermic chemical reaction, warming the pouch, which is then applied to the heel of an infant to aid in blood draws
A caution statement is being added to remind the user to activate away from face and infant as reports of pack rupture or leaking during activation may resulting in the contents splashing into the user s eyes or onto the infant. Potential harms associated with contact of the liquid inside the pouch are rash, burn and inflammation.
- 2021-07-28FDA-DeviceCardinal Health 200, LLCClass IIInfant Heel Warmer with Attachment Tab, Nonsterile, Active Product SKU MH00002T The infant heel warmer is activated at the point of care by squeezing the pouch. This mixes the substrates inside the pouch causing an exothermic chemical reaction, warming the pouch, which is then applied to the heel of an infant to aid in blood draws
A caution statement is being added to remind the user to activate away from face and infant as reports of pack rupture or leaking during activation may resulting in the contents splashing into the user s eyes or onto the infant. Potential harms associated with contact of the liquid inside the pouch are rash, burn and inflammation.
- 2021-07-28FDA-DeviceFresenius Medical Care Holdings, Inc.Class IIThe MTS Set is a single-use, sterile (EO), non-pyrogenic, optional accessory that provides additional connections/disconnections when used with a stay"safe compatible cycler set during acute and chronic PD treatment. The MTS Set utilizes the same PIN engagement technology used in Fresenius stay"safe Patient Connectors (K041792). The MTS Set consists of two (2) stay"safe PIN Connectors at the proximal end, tubing, and a Safe-Lock connector at the distal end. The MTS Set is attached to a cycler se
Exposed to freezing temperatures due to refrigerated truck malfunctions
- 2021-07-28FDA-DeviceFresenius Medical Care Holdings, Inc.Class IINaturaLyte Dry Bicarbonate Concentrate is composed of sodium bicarbonate powder and is used as one component in the preparation of dialysate in a 3-stream proportioning hemodialysis machine according to a physician s prescription. NaturaLyte Dry Bicarbonate Concentrate is formulated for use in 45X proportioning systems which proportion a nominal ratio of 1 : 1.72 : 42.28 (acid : bicarbonate : water) to generate dialysate. The dialysate is intended to be pumped through a dialyzer, creating an osm
Exposed to freezing temperatures due to refrigerated truck malfunctions
- 2021-07-28FDA-DeviceFresenius Medical Care Holdings, Inc.Class IICitrasate Liquid Acid Concentrate and NaturaLyte Liquid Acid Concentrate are each intended to be used as one component in the preparation of dialysate in a 3-stream proportioning hemodialysis machine according to a physician s prescription. Both concentrates are formulated for use in 45X proportioning systems which proportion a nominal ratio of 1 : 1.72 : 42.28 (acid : bicarbonate : water) to generate dialysate. The dialysate is intended to be pumped through a dialyzer, creating an osmotic gradi
Exposed to freezing temperatures due to refrigerated truck malfunctions
- 2021-07-28FDA-DeviceFresenius Medical Care Holdings, Inc.Class IICitrasate Dry Acid Concentrate and GranuFlo Dry Acid Concentrate are each intended to be used as one component in the preparation of dialysate in a 3-stream proportioning hemodialysis machine according to a physician s prescription. Both concentrates are formulated for use in 45X proportioning systems which proportion a nominal ratio of 1 : 1.72 : 42.28 (acid : bicarbonate : water) to generate dialysate. The dialysate is intended to be pumped through a dialyzer, creating an osmotic gradient acro
Exposed to freezing temperatures due to refrigerated truck malfunctions
- 2021-07-28FDA-DeviceFresenius Medical Care Holdings, Inc.Class II(1) 08-4078-BB BIBAG 650 GRAMS/BAG 16 BAGS/CASE (2) 08-4080-BB BIBAG 900 grams/bag 12 bags/case For patients with acute and chronic end stage renal disease going under PD in healthcare or home setting GRANUFLO & NATURALYTE: Concentrate is formulated to be used in conjunction with Fresenius Renal Technologies Sodium Bicarbonate Concentrate in a compatible 45X dilution three-stream artificial kidney (hemodialysis) machine.
Exposed to freezing temperatures due to refrigerated truck malfunctions
- 2021-07-28CPSCBirkenstock USA, of Novato, Calif.Birkenstock USA Recalls Kids' Mogami Sandals Due to Choking Hazard
A plastic rivet can detach from the sandal's ankle strap, posing a choking hazard for young children.
- 2021-07-28CPSCTkala Fashion, of Shenzen, ChinaChildren's Pajamas Recalled Due to Violation of Federal Flammability Standard and Burn Hazard; Manufactured by Tkala Fashion; Sold Exclusively on Amazon.com
The pajamas fail to meet the federal flammability standards for children's sleepwear, posing a risk of burn injuries to children.
- 2021-07-22CPSCBel Furniture Inc., of Houston, TexasBel Furniture Recalls Barrington 5-Drawer Chests Due to Tip-Over and Entrapment Hazards; Sold Exclusively at Bel Furniture (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 F2057-14.
- 2021-07-21FDA-DeviceGE Healthcare, LLCClass II1.5T SIGNA HDxt (HD28) MR System, Nuclear Magnetic Resonance Imaging System
GE Healthcare has recently become aware of an issue on the affected products listed below where the "Patient Orientation" button may inadvertently be clicked when intending to click on the "Save RX" button. This changes the prescribed patient orientation on the system prior to running the initial 3-Plane Localizer Scan (See Figure 1 for reference to buttons.) Selecting and saving a patient orientation that does not match the patient's actual position may result in incorrectly annotated and/or flipped images.
- 2021-07-21FDA-DeviceGE Healthcare, LLCClass IIDiscovery MR450 1.5T, Nuclear Magnetic Resonance Imaging System
GE Healthcare has recently become aware of an issue on the affected products listed below where the "Patient Orientation" button may inadvertently be clicked when intending to click on the "Save RX" button. This changes the prescribed patient orientation on the system prior to running the initial 3-Plane Localizer Scan (See Figure 1 for reference to buttons.) Selecting and saving a patient orientation that does not match the patient's actual position may result in incorrectly annotated and/or flipped images.
- 2021-07-21FDA-DeviceGE Healthcare, LLCClass IIOptima MR450w 1.5T, Nuclear Magnetic Resonance Imaging System
GE Healthcare has recently become aware of an issue on the affected products listed below where the "Patient Orientation" button may inadvertently be clicked when intending to click on the "Save RX" button. This changes the prescribed patient orientation on the system prior to running the initial 3-Plane Localizer Scan (See Figure 1 for reference to buttons.) Selecting and saving a patient orientation that does not match the patient's actual position may result in incorrectly annotated and/or flipped images.
- 2021-07-21FDA-DeviceGE Healthcare, LLCClass IISIGNA Voyager, Nuclear Magnetic Resonance Imaging System
GE Healthcare has recently become aware of an issue on the affected products listed below where the "Patient Orientation" button may inadvertently be clicked when intending to click on the "Save RX" button. This changes the prescribed patient orientation on the system prior to running the initial 3-Plane Localizer Scan (See Figure 1 for reference to buttons.) Selecting and saving a patient orientation that does not match the patient's actual position may result in incorrectly annotated and/or flipped images.
- 2021-07-21FDA-DeviceGE Healthcare, LLCClass IISIGNA Artist, Nuclear Magnetic Resonance Imaging System
GE Healthcare has recently become aware of an issue on the affected products listed below where the "Patient Orientation" button may inadvertently be clicked when intending to click on the "Save RX" button. This changes the prescribed patient orientation on the system prior to running the initial 3-Plane Localizer Scan (See Figure 1 for reference to buttons.) Selecting and saving a patient orientation that does not match the patient's actual position may result in incorrectly annotated and/or flipped images.
- 2021-07-21FDA-DeviceGE Healthcare, LLCClass IISIGNA MR380, Nuclear Magnetic Resonance Imaging System
GE Healthcare has recently become aware of an issue on the affected products listed below where the "Patient Orientation" button may inadvertently be clicked when intending to click on the "Save RX" button. This changes the prescribed patient orientation on the system prior to running the initial 3-Plane Localizer Scan (See Figure 1 for reference to buttons.) Selecting and saving a patient orientation that does not match the patient's actual position may result in incorrectly annotated and/or flipped images.
- 2021-07-21FDA-DeviceGE Healthcare, LLCClass IISIGNA MR355, SIGNA MR360, Nuclear Magnetic Resonance Imaging System
GE Healthcare has recently become aware of an issue on the affected products listed below where the "Patient Orientation" button may inadvertently be clicked when intending to click on the "Save RX" button. This changes the prescribed patient orientation on the system prior to running the initial 3-Plane Localizer Scan (See Figure 1 for reference to buttons.) Selecting and saving a patient orientation that does not match the patient's actual position may result in incorrectly annotated and/or flipped images.
- 2021-07-21FDA-DeviceGE Healthcare, LLCClass IISIGNA Creator, SIGNA Explorer, Nuclear Magnetic Resonance Imaging System
GE Healthcare has recently become aware of an issue on the affected products listed below where the "Patient Orientation" button may inadvertently be clicked when intending to click on the "Save RX" button. This changes the prescribed patient orientation on the system prior to running the initial 3-Plane Localizer Scan (See Figure 1 for reference to buttons.) Selecting and saving a patient orientation that does not match the patient's actual position may result in incorrectly annotated and/or flipped images.
- 2021-07-21FDA-DeviceGE Healthcare, LLCClass IISIGNA PET/MR, Tomographic Imager Combining Emission Computed Tomography With Nuclear Magnetic Resonance
GE Healthcare has recently become aware of an issue on the affected products listed below where the "Patient Orientation" button may inadvertently be clicked when intending to click on the "Save RX" button. This changes the prescribed patient orientation on the system prior to running the initial 3-Plane Localizer Scan (See Figure 1 for reference to buttons.) Selecting and saving a patient orientation that does not match the patient's actual position may result in incorrectly annotated and/or flipped images.
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