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.
- 2021-07-28FDA-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.
- 2021-07-21FDA-DeviceGE Healthcare, LLCClass IIDiscovery MR750 3.0T - Product Usage: is a whole body magnetic resonance scanner designed to support high resolution, high signal-to-noise ratio, and short scan times.
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 MR750w 3.0T - Product Usage: is a whole body magnetic resonance scanner designed to support high resolution, high signal-to-noise ratio, and short scan times.
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 Pioneer - Product Usage: is a whole body magnetic resonance scanner designed to support high resolution, high signal-to-noise ratio, and short scan times.
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 Architect - Product Usage: is a whole body magnetic resonance scanner designed to support high resolution, high signal-to-noise ratio, and short scan times.
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 Premier - Product Usage: is a whole body magnetic resonance scanner designed to support high resolution, high signal-to-noise ratio, and short scan times.
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-FoodBea Lydeckers Naturals IncClass IILiving Free Nerve & Muscle Plus Cetyl-Myristoleate Herbal and Glandular Supplement, 180 and 500 capsules per bottles. Product is packed in white, HDPE plastic bottles with threaded HDPE lids. Label is read in parts: "***Living Free Nerve & Muscle Plus Cetyl-Myristoleate *** Herbal and Glandular Supplement***Formulated by Beatrice Lydecker ***Manufactured by Bea Lydecker's Naturals Oregon City, OR***".
Label declares lecithin but does not declare soy lecithin.
- 2021-07-21FDA-FoodBea Lydeckers Naturals IncClass IILiving Free Nerve & Muscle Herbal Dietary Supplement, 100 and 500 capsules per bottles. Product is packed in white, HDPE plastic bottles with threaded HDPE lids. Label is read in parts: "***Living Free Nerve & Muscle Herbal Dietary Supplement***Herbal and Glandular Supplement***Formulated by Beatrice Lydecker ***Manufactured by Bea Lydecker's Naturals Oregon City, OR*** 503-631-8589***".
Label declares lecithin but does not declare soy lecithin.
- 2021-07-21FDA-FoodBea Lydeckers Naturals IncClass IILiving Free Lung & Joint Congestion Herbal Dietary Supplement, 100 and 500 capsules per bottles. Product is packed in white, HDPE plastic bottles with threaded HDPE lids. Label is read in parts: "***Living Free Lung & Joint Congestion Herbal Dietary Supplement***Glandular, Herbal & Vitamin Supplement***Formulated by Beatrice Lydecker ***Manufactured by Bea Lydecker's Naturals Oregon City, OR*** 503-631-8589***".
Label declares lecithin but does not declare soy lecithin.
- 2021-07-21FDA-FoodBea Lydeckers Naturals IncClass IILiving Free Immune Dietary Supplement, 100 and 500 capsules per bottles. Product is packed in white, HDPE plastic bottles with threaded HDPE lids. Label is read in parts: "***Living Free Immune Dietary Supplement***Glandular and Herbal Supplement***Formulated by Beatrice Lydecker ***Manufactured by Bea Lydecker's Naturals Oregon City, OR*** 503-631-8589***".
Label declares lecithin but does not declare soy lecithin.
- 2021-07-21FDA-FoodBea Lydeckers Naturals IncClass IILiving Free Heart/Blood Vessel Dietary Supplement, 100 or 500 capsules per bottle. Product is packed in white, HDPE plastic bottles with threaded HDPE lids. Label is read in parts: "***Living Free Heart/Blood Vessel Dietary Supplement***Glandular Herbal & Vitamin Blend***Formulated by Beatrice Lydecker ***Manufactured by Bea Lydecker's Naturals Oregon City, OR*** 503-631-8589***".
Label declares lecithin but does not declare soy lecithin.
- 2021-07-21FDA-FoodBea Lydeckers Naturals IncClass IILiving Free "Adult Extra" multi-vitamin, 100 or 500 capsules per bottle. Product is packed in white, HDPE plastic bottles with threaded HDPE lids. Label is read in parts: "**Living Free Adult Extra***Natural Vitamin Mineral Herbal Glandular Supplements***Formulated and Manufactured by BEA LYDECKER's NATURALS Oregon City, OR*** 503-631-8589***".
Label declares lecithin but does not declare soy lecithin.
- 2021-07-21FDA-DrugSanit Technologies, LLC dba DurisanClass IIDurisan Antimicrobial Solutions (benzalkonium chloride) Hand Sanitizer, listed as 0.1% or 0.13%, Alcohol-Free, packaged in a) 18 mL Net Content 0.61 fl oz credit card size container, (UPC 8 52379 00614 1); b) 50 mL Net Content 1.69 oz bottle, (UPC 8 52379 00634 9 and 8 52379 00612 7); c) 118 mL Net Content 4 oz bottle, (UPC 8 52379 00634 9 and 8 52379 00612 9); d) 236.58 mL Net Content 8 oz bottle, (UPC 8 52379 00635 6); e) 250 mL Net Contents 8.45 oz (UPC 8 52379 00611 0); f) 300 mL Net Content
CGMP Deviations: lots recalled due to CGMP deviations because they were manufactured under the same conditions as product lots found to be contaminated.
- 2021-07-21FDA-DrugSanit Technologies, LLC dba DurisanClass IDurisan Antimicrobial Solutions (benzalkonium chloride) Hand Sanitizer, listed as 0.1% or 0.13%, Alcohol-Free, packaged in a) 18 mL Net Content 0.61 fl oz credit card size container, (UPC 8 52379 00614 1); b) 50 mL Net Content 1.69 oz bottle, (UPC 8 52379 00634 9 and 8 52379 00612 7); c) 118 mL Net Content 4 oz bottle, (UPC 8 52379 00634 9 and 8 52379 00612 9); d) 236.58 mL Net Content 8 oz bottle, (UPC 8 52379 00635 6); e) 250 mL Net Contents 8.45 oz (UPC 8 52379 00611 0); f) 300 mL Net Content
Microbial Contamination of Non-Sterile Products: firm's internal testing found certain lots of the product to be contaminated with Burkholderia contaminans and/or yeast and mold.
- 2021-07-14FDA-DeviceGE Healthcare, LLCClass IIThe system is intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission projection data from the same axial plane taken at different angles. The system has the capability to image whole organs in a single rotation. Whole organs include but are not limited to brain, heart, liver, kidney, pancreas, etc. The system may acquire data using Axial, Cine, Helical, Cardiac, and Gated CT scan techniques from patients of all ages. These images may be obtained e
When adding one or more intended scan groups names must contain only letters, numbers (0-9), or a space or the user interface will not update to confirm the intended group(s) has been added to the acquisition.
- 2021-07-14FDA-DeviceGE Healthcare, LLCClass IIThe system is intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission projection data from the same axial plane taken at different angles. The system has the capability to image whole organs in a single rotation. Whole organs include but are not limited to brain, heart, liver, kidney, pancreas, etc. The system may acquire data using Axial, Cine, Helical, Cardiac, and Gated CT scan techniques from patients of all ages. These images may be obtained
When adding one or more intended scan groups names must contain only letters, numbers (0-9), or a space or the user interface will not update to confirm the intended group(s) has been added to the acquisition.
- 2021-07-14FDA-DeviceGE Healthcare, LLCClass IIRevolution CT
GE Healthcare has become aware of a potential issue on the Revolution CT system where a collimator blade does not find its appropriate home position. This issue could result in the delivered dose of x-ray radiation being either larger or smaller than its prescribed value.
- 2021-07-14FDA-FoodBeechnut NutritionClass IIBeech-Nut brand Single Grain Rice Baby Cereal; NET WT. 8 OZ (227g); INGREDIENTS: Rice flour, sunflower lecithin; packaged in an 8oz plastic canister with safety seal, screw on inner cap and an over cap.
Product may contain elevated levels of inorganic arsenic (above 100ppb)
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