Baby and kids' product recalls
6737 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.
- 2016-08-03FDA-DeviceDraeger Medical, Inc.Class IIBabytherm 8004/8010, Infant Warmer, Class II device, 510 K K971198, Catalog # FR00105 (Babytherm 8010), 2M30404 (Babytherm 8004), non sterile, software controlled. Product Usage: Babytherm 8004/8010 is an open care infant warmer system for warming premature babies, neonates and infants with a body weight of up to 8 kg (17.6 lbs). The device is intended for use in delivery rooms, operating rooms, maternity and obstetric units, neonatal and pediatric wards, neonatal and pediatric intensive car
Risk associated with operating the device in skin temperature mode with temperature sensors attached but no patient connected.
- 2016-08-03FDA-DeviceAlere San Diego, Inc.Class IIISignify Mono (Whole Blood, Serum, Plasma), Catalog No. 01P52-25 a simple test that utilizes an extract of bovine erythrocytes to qualitatively and selectively detect IM heterophile antibodies in whole blood, serum or plasma in just minutes.
The Positive Control information referencing human plasma as the antibody material described in the product labeling and packaging is incorrect.
- 2016-08-03FDA-DeviceAlere San Diego, Inc.Class IIIStanbio Rely Mono Rapid Test, Catalog No. 6200-010L and 6200-020L a simple test that utilizes an extract of bovine erythrocytes to qualitatively and selectively detect IM heterophile antibodies in whole blood, serum or plasma in just minutes.
The Positive Control information referencing human plasma as the antibody material described in the product labeling and packaging is incorrect.
- 2016-08-03FDA-DeviceAlere San Diego, Inc.Class IIIProadvantage Mono Rapid Test Cassette, Catalog No. P080016 a simple test that utilizes an extract of bovine erythrocytes to qualitatively and selectively detect IM heterophile antibodies in whole blood, serum or plasma in just minutes.
The Positive Control information referencing human plasma as the antibody material described in the product labeling and packaging is incorrect.
- 2016-08-03FDA-DeviceAlere San Diego, Inc.Class IIIHenry Schein One Step + Mono Rapid Test Device, Catalog No. 9004070 a simple test that utilizes an extract of bovine erythrocytes to qualitatively and selectively detect IM heterophile antibodies in whole blood, serum or plasma in just minutes.
The Positive Control information referencing human plasma as the antibody material described in the product labeling and packaging is incorrect.
- 2016-08-03FDA-DeviceAlere San Diego, Inc.Class IIIClearview MONO (Whole Blood, Serum, Plasma), Catalog No. 92401 a simple test that utilizes an extract of bovine erythrocytes to qualitatively and selectively detect IM heterophile antibodies in whole blood, serum or plasma in just minutes.
The Positive Control information referencing human plasma as the antibody material described in the product labeling and packaging is incorrect.
- 2016-08-03FDA-DeviceAlere San Diego, Inc.Class IIICardinal Health Mono Rapid Test, Catalog No. B1077-28, a simple test that utilizes an extract of bovine erythrocytes to qualitatively and selectively detect IM heterophile antibodies in whole blood, serum or plasma in just minutes.
The Positive Control information referencing human plasma as the antibody material described in the product labeling and packaging is incorrect.
- 2016-08-03FDA-DeviceAlere San Diego, Inc.Class IIIAcceava Mono II Rapid Test Strip (Whole Blood, Serum, Plasma), Catalog No. 92404. Mononucleosis Rapid Test Device a simple test that utilizes an extract of bovine erythrocytes to qualitatively and selectively detect IM heterophile antibodies in whole blood, serum or plasma.
The Positive Control information referencing human plasma as the antibody material described in the product labeling and packaging is incorrect.
- 2016-08-03FDA-FoodCRF Frozen Foods, LLCClass IGreen Peas, Brand Bybee's Best, Net Wt 20 lb, UPC 4635800011 Green Peas, Brand Byee Foods, Net Wt 50 lb, UPC 155000007785CR Organic Sweet Baby Peas, Brand Bybee Foods, Net Wt 5 lb, UPC 5711000145 Organic Petite Peas, Brand Columbia River Organics, Net Wt 10 oz, UPC 5711000109 Green Peas, Brand Northwest Growers Select, Net Wt 20 lb, UPC 5711000152 Green Peas, Brand Northwest Growers Select, Net Wt 55 lb, UPC 45721084 Organic Peas, Brand Northwest Growers Select, Net Wt 30 lb, UPC 57110
Peas are recalled because they have the potential to be contaminated with Listeria monocytogenes.
- 2016-08-03FDA-FoodCRF Frozen Foods, LLCClass IBaby Lima Beans, Brand Parade, Net Wt 16 oz, UPC 5070030670 Baby Lima Beans, Safeway Kitchens, Net Wt 20 oz, UPC 2113009144 Lima Beans, Brand Signature Kitchens, Net Wt 16 oz, UPC 2113009946 Lima Beans, Brand Signature Kitchens, Net Wt 20 oz, UPC 2113009944 Baby Lima Beans, Brand VIP, Net Wt 16 oz, UPC 7007701016 Baby Lima Beans, Brand Quirch, Net Wt 14 oz, UPC 6507260150 Baby Lima Beans, Brand Quirch, Net Wt 32 oz, UPC 6507260149
Lima Beans are recalled because they have the potential to be contaminated with Listeria monocytogenes.
- 2016-08-03USDAClass IIStop using Wegmans Handcrafted Bangers sausage
Misbranding
- 2016-08-02CPSCStarbucks Corp., of Seattle, Wash.Laceration Injuries to Children Prompt Starbucks to Recall Stainless Steel Beverage Straws to Provide New Warnings
The stainless steel straws are rigid and can poke children in the mouth, posing a risk of injury.
- 2016-07-28USDAClass IDo not eat Casa di Trevi meat pasta products
Misbranding, Produced Without Benefit of Inspection, Unreported Allergens
- 2016-07-27FDA-DeviceAmerx Health Care Corp.Class IIAmerigel Hydrogel Wound Dressing Advanced Formula for wound management 1 oz.
Product did not meet specifications for Zinc Acetate (OOS).
- 2016-07-27FDA-DeviceBayer HealthcareClass IIAngiographic Injector and Syringe, MEDRAD MRXperion MR Injection System, MEDRAD MRXperion Sterile Disposable MRI Kit Usage: The MEDRAD MRXperion MR Injection System is a syringe based fluid delivery system indicated for delivery of contrast media and saline during MR applications. It is intended to be used for the specific purpose of injecting intravenous MR contrast media and saline into the human vascular system for diagnostic studies in magnetic resonance imaging (MRI) applications with M
Bayer Healthcare is initiating this recall due to complaints that were received from customer sites describing a 4205 error message when the injector is used with a 3T scanner.
- 2016-07-27FDA-FoodCRF Frozen Foods, LLCClass IFrozen Organic Super Sweet White Corn, Organic by Nature, net wt. 5 lb. The UPC is 8 46358 00064 0. Frozen Organic Super Sweet White Corn, Organic by Nature brand, net wt. 4 lb. The UPC is 8 46358 00070 1. Organic Super Sweet Yellow and White Cut Corn, Live Smart Schwan's brand, net wt. 16 oz. The UPC is 0 07218 06043 3. Frozen Organic White Sweet Corn, True Goodness by Meijer brand, net wt. 10 oz. The UPC is 7 13733 43098 2. *********************************************************
Organic White Sweet Corn is recalled due to a potential for contamination with Listeria monocytogenes.
- 2016-07-27FDA-FoodCRF Frozen Foods, LLCClass IFrozen Organic Premium Sweet Baby Peas, Organic by Nature brand, net wt. 5 lb. The UPC is 8 46358 00063 3. Frozen IQF Organic Premium Sweet Baby Peas, Organic by Nature brand, net wt. 4 lb. The UPC is 8 46358 00069 5. Frozen Organic Premium Quality Sweet Peas, Organic by Nature brand (Canada); net wet 2.5 kg. The UPC is 8 46358 00061 9. Frozen Organic Petite Green Peas, True Goodness by Meijer brand, net wt. 10 oz. The UPC is 7 13733 43099 9. Frozen Organic Peas, Wellsley Far
Frozen Organic Peas product is recalled due to a potential for contamination with Listeria monocytogenes.
- 2016-07-27FDA-FoodKellogg CompanyClass IKashi Whole Grain Bars 35 g individual bar, 18 count retail carton (630 g), 6 cartons per case
Product contains sunflower seeds potentially contaminated with Listeria monocytogenes. Listeria monocytogenes, 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.
- 2016-07-27FDA-FoodKellogg CompanyClass IKashi Whole Grain Trail Mix Bars 35 g individual bar, 6 count retail carton (210 g), 12 cartons per case
Product contains sunflower seeds potentially contaminated with Listeria monocytogenes. Listeria monocytogenes, 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.
- 2016-07-27FDA-FoodKellogg CompanyClass IBear Naked Soft Baked Granola, Pepita + Hemp + Sunflower Butter 10.5 oz. retail unit, 6 count carton, 1 cartons per case;
Product contains sunflower seeds potentially contaminated with Listeria monocytogenes. Listeria monocytogenes, 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.
- 2016-07-27FDA-FoodKellogg CompanyClass IBear Naked Soft Baked Granola, Cinnamon + Sunflower Butter 11 oz. retail unit, 6 count carton, 1 cartons per case; 26 oz. club store retail unit, 1 count carton, 1 carton per case; 1.2 oz. food service sample unit, 50 count carton, 1 carton per case
Product contains sunflower seeds potentially contaminated with Listeria monocytogenes. Listeria monocytogenes, 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.
- 2016-07-27FDA-FoodKellogg CompanyClass IKashi GOLEAN Honey Pecan Baklava Bars 1.59 oz. individual bar 5 count retail carton (7.95 oz.), 6 cartons per case; 8 count carton (12.72 oz.); 12 count food service carton (19 oz.), 1 carton per case
Product contains sunflower seeds potentially contaminated with Listeria monocytogenes. Listeria monocytogenes, 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.
- 2016-07-27FDA-FoodKellogg CompanyClass IKashi Chewy Trail Mix Granola Bars 1.2 oz individual bar 6 count retail carton (7.4 oz.), 12 carton per case; 35 count club store carton (42 oz.), 1 carton per case; 12 count food service carton (14.4 oz.), 6 carton per case
Product contains sunflower seeds potentially contaminated with Listeria monocytogenes. Listeria monocytogenes, 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.
- 2016-07-27CPSCNovel Laboratories, of Somerset, N.J.Novel Laboratories Recalls Zolpidem Tartrate Blister Packs Due to Failure to Meet Child-Resistant Closure Requirement; Risk of Poisoning
The packaging for the prescription drug is not child-resistant as required by the Poison Prevention Packaging Act, posing a risk of poisoning if swallowed by children.
- 2016-07-26CPSCSmocked Threads by Cecil & Lou, of Tyler, TexasSmocked Threads by Cecil & Lou 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.
- 2016-07-21CPSCFLIR Commercial Systems Inc., of Goleta, Calif.Lorex Recalls Video Baby Monitors Due to Burn Hazard
The video monitor's batteries can overheat, swell and expand and cause the battery cover to open or come off. This can expose hot batteries, posing a burn hazard to consumers.
- 2016-07-21USDAClass IDon't eat Kapowsin Meats whole hogs
Product Contamination
- 2016-07-20USDAPublic Health AlertDo not eat Kapowsin Meats roasted pigs
Product Contamination
- 2016-07-20FDA-DeviceVarian Medical Systems, Inc.Class IIOptical Surface Monitoring System{Align RT Plus} This is used on Varian's TrueBeam EDGE; Radiology: The AlignRT Plus system is indicated for use to position and monitor patients relative to the prescribed treatment isocentre, and to Withhold the beam automatically during radiation delivery.
Varian Medical Systems has received reports that unintended changes were made to planned couch parameters, specifically the couch rotation parameter, during patient set-up. This can occur when a user sets a different couch rotation from the plan couch rotation while performing patient alignment with Optical Surface Monitoring System [OSMS].
- 2016-07-20FDA-DeviceVarian Medical Systems, Inc.Class IIOptical Surface Monitoring System{OSMS, Varian Private Label} This is used on Varian's TrueBeam EDGE; Radiology: The AlignRT Plus system is indicated for use to position and monitor patients relative to the prescribed treatment isocentre, and to Withhold the beam automatically during radiation delivery.
Varian Medical Systems has received reports that unintended changes were made to planned couch parameters, specifically the couch rotation parameter, during patient set-up. This can occur when a user sets a different couch rotation from the plan couch rotation while performing patient alignment with Optical Surface Monitoring System [OSMS].
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