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.
- 2016-10-12FDA-DeviceTrumpf Medical Systems, Inc.Class IIOperating Table TruSystem 7000 U, Material Number 1604788; Operating Table TruSystgem 7000 U (MB), Material Number 1604786 Patient positioning during surgery, ranging from anesthesia induction to actual surgery to recover from the anesthesia. Also, patient transport on the operating table top from a patient transfer system to the operating theater of from the operating theater to a patient transfer system
Three complaints describing TruSystem tables unexpectedly descending approximately 20 centimeters.
- 2016-10-12FDA-DeviceTrumpf Medical Systems, Inc.Class IIFloor Mounting Column TS 7500 U, Material Number 1730732; Floor Mounting Column ARTIS, Material Number 1501878 Patient positioning during surgery, ranging from anesthesia induction to actual surgery to recover from the anesthesia. Also, patient transport on the operating table top from a patient transfer system to the operating theater of from the operating theater to a patient transfer system.
Three complaints describing TruSystem tables unexpectedly descending approximately 20 centimeters.
- 2016-10-12FDA-DeviceTrumpf Medical Systems, Inc.Class IIStationary Column TruSystem 7599, Material Number 1717020 Patient positioning during surgery, ranging from anesthesia induction to actual surgery to recover from the anesthesia. Also, patient transport on the operating table top from a patient transfer system to the operating theater of from the operating theater to a patient transfer system.
Three complaints describing TruSystem tables unexpectedly descending approximately 20 centimeters.
- 2016-10-12FDA-DeviceTrumpf Medical Systems, Inc.Class IIMobile Column TruSystem 7500, Material Number 1717023; Mobile Column TruSystem 5500, Material Number 1607822 Patient positioning during surgery, ranging from anesthesia induction to actual surgery to recover from the anesthesia. Also, patient transport on the operating table top from a patient transfer system to the operating theater of from the operating theater to a patient transfer system
Three complaints describing TruSystem tables unexpectedly descending approximately 20 centimeters.
- 2016-10-12FDA-DevicePhilips Medical SystemsClass IIIngenuity CT Model Number 728326 Product Usage: Computed Tomography X-ray systems intended to product cross-sectional images of the body by computer reconstruction of X-ray transmission data taken at different angles and planes.
The infant performance test did not meet the test specification for the Infant Head Uniformity test with High Resolution. As a result, when the user performs High Resolution head scans, the reconstructed images may exhibit degraded image quality manifested as non-uniformity of the image, CT number shift greater than 5 Hounsfield units, and reduction in gray/white matter differentiation. The issue is most sever in the High Resolution mode, and the factory reference pediatric scan protocols are set to High Resolution default. Adults head scans have a factory reference protocol that defaults to standard resolution which doesn't experience the issue.
- 2016-10-12FDA-DevicePhilips Medical SystemsClass IIIngenuity Core 128 Model Number 728323 Product Usage: Computed Tomography X-ray systems intended to product cross-sectional images of the body by computer reconstruction of X-ray transmission data taken at different angles and planes.
The infant performance test did not meet the test specification for the Infant Head Uniformity test with High Resolution. As a result, when the user performs High Resolution head scans, the reconstructed images may exhibit degraded image quality manifested as non-uniformity of the image, CT number shift greater than 5 Hounsfield units, and reduction in gray/white matter differentiation. The issue is most sever in the High Resolution mode, and the factory reference pediatric scan protocols are set to High Resolution default. Adults head scans have a factory reference protocol that defaults to standard resolution which doesn't experience the issue.
- 2016-10-12FDA-DevicePhilips Medical SystemsClass IIIngenuity Core Model Number 728321 Product Usage: Computed Tomography X-ray systems intended to product cross-sectional images of the body by computer reconstruction of X-ray transmission data taken at different angles and planes.
The infant performance test did not meet the test specification for the Infant Head Uniformity test with High Resolution. As a result, when the user performs High Resolution head scans, the reconstructed images may exhibit degraded image quality manifested as non-uniformity of the image, CT number shift greater than 5 Hounsfield units, and reduction in gray/white matter differentiation. The issue is most sever in the High Resolution mode, and the factory reference pediatric scan protocols are set to High Resolution default. Adults head scans have a factory reference protocol that defaults to standard resolution which doesn't experience the issue.
- 2016-10-12FDA-DevicePhilips Medical SystemsClass IIBrilliance 64 CT Model Number 728231 Product Usage: Computed Tomography X-ray systems intended to product cross-sectional images of the body by computer reconstruction of X-ray transmission data taken at different angles and planes.
The infant performance test did not meet the test specification for the Infant Head Uniformity test with High Resolution. As a result, when the user performs High Resolution head scans, the reconstructed images may exhibit degraded image quality manifested as non-uniformity of the image, CT number shift greater than 5 Hounsfield units, and reduction in gray/white matter differentiation. The issue is most sever in the High Resolution mode, and the factory reference pediatric scan protocols are set to High Resolution default. Adults head scans have a factory reference protocol that defaults to standard resolution which doesn't experience the issue.
- 2016-10-12FDA-DeviceMicrogenics CorporationClass IIThermo Scientific QMS Everolimus Assay; Model number: 0380000 (US Distribution); 0373852 (Foreign Distribution) Product Usage: The QMS Everolimus Assay is intended for the quantitative determination of Everolimus, in human whole blood on automated clinical chemistry analyzers. The results obtained are used as an aid in the management of kidney and liver transplant patients receiving Everolimus therapy. This in vitro diagnostic device is intended for clinical laboratory use only. The QMS E
A reagent stability issue (still under investigation) causes less separation in the calibration curve, which affects results across the entire range. For controls, maximum bias of +/- 35% for low levels, +/- 33% for mid-range levels, and +/- 47% for high levels is observed. Bias in patient samples ranges from -15.7% to +5.2% with an average bias of -5.6% when comparing the QMS everolimus assay to an everolimus LC-MS reference method. Patient samples across the measuring range sub-therapeutic, therapeutic, and supra-therapeutic could be affected.
- 2016-10-12CPSCMamas & Papas Ltd, of UKMamas & Papas Recalls Armadillo Strollers Due to Fall Hazard
A loose latch on the stroller can cause the seat to tip back unexpectedly when infant is in the parent-facing position, posing a fall hazard to infants.
- 2016-10-09USDAPublic Health AlertDo not eat Costco Rotisserie Chicken Salad from Lynwood store
Product Contamination
- 2016-10-06CPSCSummer Infant, Inc., of Woonsocket, R.I.Summer Infant Recalls Infant Bath Tubs Due to Risk of Impact Injury and Drowning
Fabric slings on the recalled infant bath tubs can detach from the tub, posing a risk of impact injury and drowning.
- 2016-10-05FDA-FoodGrassfields Cheese, LLCClass ICrofters 12 pound wheels, Six pound half wheels, and wedges of various sizes ranging from less than 12 pounds to 1/3 pound. Wheels and half wheels are sold packaged in cheese paper and wedges are sold packaged in clear plastic cryovac. Refrigerated, Organic raw milk cheese.
contamination with Shiga toxin-producing E. coli (STEC), a bacteria that can cause serious illness in humans. E.coli infection symptoms vary by individual, but often include severe stomach cramps, diarrhea (often bloody), and vomiting. If there is fever, it usually is not very high (less than 101¿F/less than 38.5¿C). Most people get better within 57 days. Some infections are very mild, but others are severe or even life-threatening. Around 510% of those diagnosed with Shiga-toxin producing E.coli infections develop a potentially life-threatening complication known as hemolytic uremic syndrome (HUS). Signs that a person is developing HUS include decreased frequency of urination, feeling very tired, and losing pink color in cheeks and inside the lower eyelids. Persons with HUS should be hospitalized because their kidneys may stop working and they may develop other serious problems. Most persons with HUS recover within a few weeks, but some suffer permanent damage or die.
- 2016-10-05FDA-FoodGrassfields Cheese, LLCClass IPolkton Corners 12 pound wheels, Six pound half wheels, and wedges of various sizes ranging from less than 12 pounds to 1/3 pound. Wheels and half wheels are sold packaged in cheese paper and wedges are sold packaged in clear plastic cryovac. Refrigerated, Organic raw milk cheese.
contamination with Shiga toxin-producing E. coli (STEC), a bacteria that can cause serious illness in humans. E.coli infection symptoms vary by individual, but often include severe stomach cramps, diarrhea (often bloody), and vomiting. If there is fever, it usually is not very high (less than 101¿F/less than 38.5¿C). Most people get better within 57 days. Some infections are very mild, but others are severe or even life-threatening. Around 510% of those diagnosed with Shiga-toxin producing E.coli infections develop a potentially life-threatening complication known as hemolytic uremic syndrome (HUS). Signs that a person is developing HUS include decreased frequency of urination, feeling very tired, and losing pink color in cheeks and inside the lower eyelids. Persons with HUS should be hospitalized because their kidneys may stop working and they may develop other serious problems. Most persons with HUS recover within a few weeks, but some suffer permanent damage or die.
- 2016-10-05FDA-FoodGrassfields Cheese, LLCClass IFait Fras 12 pound wheels, Six pound half wheels, and wedges of various sizes ranging from less than 12 pounds to 1/3 pound. Wheels and half wheels are sold packaged in cheese paper and wedges are sold packaged in clear plastic cryovac. Refrigerated, Organic raw milk cheese.
contamination with Shiga toxin-producing E. coli (STEC), a bacteria that can cause serious illness in humans. E.coli infection symptoms vary by individual, but often include severe stomach cramps, diarrhea (often bloody), and vomiting. If there is fever, it usually is not very high (less than 101¿F/less than 38.5¿C). Most people get better within 57 days. Some infections are very mild, but others are severe or even life-threatening. Around 510% of those diagnosed with Shiga-toxin producing E.coli infections develop a potentially life-threatening complication known as hemolytic uremic syndrome (HUS). Signs that a person is developing HUS include decreased frequency of urination, feeling very tired, and losing pink color in cheeks and inside the lower eyelids. Persons with HUS should be hospitalized because their kidneys may stop working and they may develop other serious problems. Most persons with HUS recover within a few weeks, but some suffer permanent damage or die.
- 2016-10-05FDA-FoodGrassfields Cheese, LLCClass IChili Cheese 12 pound wheels, Six pound half wheels, and wedges of various sizes ranging from less than 12 pounds to 1/3 pound. Wheels and half wheels are sold packaged in cheese paper and wedges are sold packaged in clear plastic cryovac. Refrigerated, Organic raw milk cheese.
contamination with Shiga toxin-producing E. coli (STEC), a bacteria that can cause serious illness in humans. E.coli infection symptoms vary by individual, but often include severe stomach cramps, diarrhea (often bloody), and vomiting. If there is fever, it usually is not very high (less than 101¿F/less than 38.5¿C). Most people get better within 57 days. Some infections are very mild, but others are severe or even life-threatening. Around 510% of those diagnosed with Shiga-toxin producing E.coli infections develop a potentially life-threatening complication known as hemolytic uremic syndrome (HUS). Signs that a person is developing HUS include decreased frequency of urination, feeling very tired, and losing pink color in cheeks and inside the lower eyelids. Persons with HUS should be hospitalized because their kidneys may stop working and they may develop other serious problems. Most persons with HUS recover within a few weeks, but some suffer permanent damage or die.
- 2016-10-05FDA-FoodGrassfields Cheese, LLCClass ILamont Cheddar 12 pound wheels, Six pound half wheels, and wedges of various sizes ranging from less than 12 pounds to 1/3 pound. Wheels and half wheels are sold packaged in cheese paper and wedges are sold packaged in clear plastic cryovac. Refrigerated, Organic raw milk cheese.
contamination with Shiga toxin-producing E. coli (STEC), a bacteria that can cause serious illness in humans. E.coli infection symptoms vary by individual, but often include severe stomach cramps, diarrhea (often bloody), and vomiting. If there is fever, it usually is not very high (less than 101¿F/less than 38.5¿C). Most people get better within 57 days. Some infections are very mild, but others are severe or even life-threatening. Around 510% of those diagnosed with Shiga-toxin producing E.coli infections develop a potentially life-threatening complication known as hemolytic uremic syndrome (HUS). Signs that a person is developing HUS include decreased frequency of urination, feeling very tired, and losing pink color in cheeks and inside the lower eyelids. Persons with HUS should be hospitalized because their kidneys may stop working and they may develop other serious problems. Most persons with HUS recover within a few weeks, but some suffer permanent damage or die.
- 2016-10-05FDA-FoodGrassfields Cheese, LLCClass IEdam 12 pound wheels, Six pound half wheels, and wedges of various sizes ranging from less than 12 pounds to 1/3 pound. Wheels and half wheels are sold packaged in cheese paper and wedges are sold packaged in clear plastic cryovac. Refrigerated, Organic raw milk cheese.
contamination with Shiga toxin-producing E. coli (STEC), a bacteria that can cause serious illness in humans. E.coli infection symptoms vary by individual, but often include severe stomach cramps, diarrhea (often bloody), and vomiting. If there is fever, it usually is not very high (less than 101¿F/less than 38.5¿C). Most people get better within 57 days. Some infections are very mild, but others are severe or even life-threatening. Around 510% of those diagnosed with Shiga-toxin producing E.coli infections develop a potentially life-threatening complication known as hemolytic uremic syndrome (HUS). Signs that a person is developing HUS include decreased frequency of urination, feeling very tired, and losing pink color in cheeks and inside the lower eyelids. Persons with HUS should be hospitalized because their kidneys may stop working and they may develop other serious problems. Most persons with HUS recover within a few weeks, but some suffer permanent damage or die.
- 2016-10-05FDA-FoodGrassfields Cheese, LLCClass ILeyden 12 pound wheels, Six pound half wheels, and wedges of various sizes ranging from less than 12 pounds to 1/3 pound. Wheels and half wheels are sold packaged in cheese paper and wedges are sold packaged in clear plastic cryovac. Refrigerated, Organic raw milk cheese.
contamination with Shiga toxin-producing E. coli (STEC), a bacteria that can cause serious illness in humans. E.coli infection symptoms vary by individual, but often include severe stomach cramps, diarrhea (often bloody), and vomiting. If there is fever, it usually is not very high (less than 101¿F/less than 38.5¿C). Most people get better within 57 days. Some infections are very mild, but others are severe or even life-threatening. Around 510% of those diagnosed with Shiga-toxin producing E.coli infections develop a potentially life-threatening complication known as hemolytic uremic syndrome (HUS). Signs that a person is developing HUS include decreased frequency of urination, feeling very tired, and losing pink color in cheeks and inside the lower eyelids. Persons with HUS should be hospitalized because their kidneys may stop working and they may develop other serious problems. Most persons with HUS recover within a few weeks, but some suffer permanent damage or die.
- 2016-10-05FDA-FoodGrassfields Cheese, LLCClass ICountry Dill 12 pound wheels, Six pound half wheels, and wedges of various sizes ranging from less than 12 pounds to 1/3 pound. Wheels and half wheels are sold packaged in cheese paper and wedges are sold packaged in clear plastic cryovac. Refrigerated, Organic raw milk cheese.
contamination with Shiga toxin-producing E. coli (STEC), a bacteria that can cause serious illness in humans. E.coli infection symptoms vary by individual, but often include severe stomach cramps, diarrhea (often bloody), and vomiting. If there is fever, it usually is not very high (less than 101¿F/less than 38.5¿C). Most people get better within 57 days. Some infections are very mild, but others are severe or even life-threatening. Around 510% of those diagnosed with Shiga-toxin producing E.coli infections develop a potentially life-threatening complication known as hemolytic uremic syndrome (HUS). Signs that a person is developing HUS include decreased frequency of urination, feeling very tired, and losing pink color in cheeks and inside the lower eyelids. Persons with HUS should be hospitalized because their kidneys may stop working and they may develop other serious problems. Most persons with HUS recover within a few weeks, but some suffer permanent damage or die.
- 2016-10-05FDA-FoodGrassfields Cheese, LLCClass IOnion n Garlic 12 pound wheels, Six pound half wheels, and wedges of various sizes ranging from less than 12 pounds to 1/3 pound. Wheels and half wheels are sold packaged in cheese paper and wedges are sold packaged in clear plastic cryovac. Refrigerated, Organic raw milk cheese.
contamination with Shiga toxin-producing E. coli (STEC), a bacteria that can cause serious illness in humans. E.coli infection symptoms vary by individual, but often include severe stomach cramps, diarrhea (often bloody), and vomiting. If there is fever, it usually is not very high (less than 101¿F/less than 38.5¿C). Most people get better within 57 days. Some infections are very mild, but others are severe or even life-threatening. Around 510% of those diagnosed with Shiga-toxin producing E.coli infections develop a potentially life-threatening complication known as hemolytic uremic syndrome (HUS). Signs that a person is developing HUS include decreased frequency of urination, feeling very tired, and losing pink color in cheeks and inside the lower eyelids. Persons with HUS should be hospitalized because their kidneys may stop working and they may develop other serious problems. Most persons with HUS recover within a few weeks, but some suffer permanent damage or die.
- 2016-10-05FDA-FoodGrassfields Cheese, LLCClass IGouda 12 pound wheels, Six pound half wheels, and wedges of various sizes ranging from less than 12 pounds to 1/3 pound. Wheels and half wheels are sold packaged in cheese paper and wedges are sold packaged in clear plastic cryovac. Refrigerated, Organic raw milk cheese.
contamination with Shiga toxin-producing E. coli (STEC), a bacteria that can cause serious illness in humans. E.coli infection symptoms vary by individual, but often include severe stomach cramps, diarrhea (often bloody), and vomiting. If there is fever, it usually is not very high (less than 101¿F/less than 38.5¿C). Most people get better within 57 days. Some infections are very mild, but others are severe or even life-threatening. Around 510% of those diagnosed with Shiga-toxin producing E.coli infections develop a potentially life-threatening complication known as hemolytic uremic syndrome (HUS). Signs that a person is developing HUS include decreased frequency of urination, feeling very tired, and losing pink color in cheeks and inside the lower eyelids. Persons with HUS should be hospitalized because their kidneys may stop working and they may develop other serious problems. Most persons with HUS recover within a few weeks, but some suffer permanent damage or die.
- 2016-10-04CPSCFULLBEAUTY Brands L.P., of New YorkFULLBEAUTY Brands Recalls Children's Nightgowns Due to Violation of Federal Flammability Standard (Recall Alert)
The nightgowns fail to meet federal flammability standards for children's sleepwear, posing a risk of burn injuries to children.
- 2016-10-03CPSCHallee, Inc., of Santa Cruz, CalifHallee Recalls Bed Canopies Due to Entanglement and Strangulation Hazards; Sold Exclusively at Amazon.com (Recall Alert)
A child can become entangled in the bed canopy, posing entanglement and strangulation hazards.
- 2016-09-28FDA-FoodGilbert Foods Inc.Class IBrand Name: Evies Cheddar Potato Macaroni Salad Net Weight: 6 oz. container Units per package: 1 Units per case: 6 containers per case Package Type: clear plastic container
Gilbert Foods Inc. t/a Hearn-Kirkwood is initiating a voluntary recall of Evies Cheddar Potato Macaroni Salad . The co-packer of the product, Marys Harvest Fresh Foods , notified us that the peas that were used in Evies Cheddar Potato Macaroni Salad are a part of National Frozen Foods Corporations voluntary recall. Because potentially contaminated peas were used in the Evies Cheddar Potato Macaroni Salad , there is the risk that the entire container of Evies Cheddar Potato Macaroni Salad could be contaminated with Listeria monocytogenes. Listeria monocytogenes, is an organism which can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems. Although healthy individuals may suffer only short-term symptoms such as high fever, severe headache, stiffness, nausea, abdominal pain and diarrhea, listeria infection can cause miscarriages and stillbirths among pregnant women. There have been no reported illnesses or complaints attributed to the recalled items to date.Product is shipped directly to the consumer through Amazon Fresh.
- 2016-09-27CPSCSmartPool LLC, of Lakewood, N.J.SmartPool Recalls Pool Alarms Due to Failure to Alert Consumers
The ON/OFF activation switch on the pool alarm is reversed, which can cause the alarm to fail to alert consumers if a child enters the water.
- 2016-09-27USDAClass ICaviness Beef Packers Recalls Beef Products Due to Possible E. Coli O103 Contamination
Product Contamination
- 2016-09-24USDAClass IDiscard Adams Farm beef, veal, and bison products
Product Contamination
- 2016-09-21FDA-DeviceAirStrip Technologies, Inc.Class IIAirStrip Sense4Baby Model C Fetal Monitor The Sense4Baby System Model C is indicated for monitoring of maternal and fetal physiologic parameters during the antepartum period. The Sense4Baby System is to be used by health care professionals or patients, by prescription or doctor s order, in hospitals, clinics, physicians offices, antepartum rooms, or outside a hospital or health care setting. The data interpretation is to be done by a health care professional.
Belt clip may become detached causing electronic components to be exposed.
- 2016-09-21FDA-DeviceBiosense Webster, Inc.Class IICARTO 3 EP Navigation System and Accessories, Product Codes: FG540000 and FG540000C, Software Versions: v 3.2 , v 4.3 and v 2.3. The CARTO 3 EP Navigation System is intended to be used in catheter-based cardiac electrophysiological (EP) procedures. The CARTO 3 System provides information about the electrical activity of the heart and catheter location during the procedure.
Biosense Webster, Inc. is initiating a voluntary correction to re-install identified CARTO 3 Systems that were moved and installed in China without testing and approval by Biosense Webster Technical Services, as described in the Instructions for Use (IFU).
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