Baby and kids' product recalls
6675 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.
- 2013-09-18FDA-DeviceRoche Molecular Systems, Inc.Class IIKIT cobas 4800 HPV AMP/DET 240T / 960T US-IVD, CE-IVD Roche Molecular System, Inc. 1080 US highway 202 South Branchburg, NJ 08876 USA Roche Diagnostics 9115 Hague Road Indianapolis, IN 46250-0457 USA The cobas¿ HPV Test is a qualitative in vitro test for the detection of Human Papillomavirus in patient specimens. The test utilizes amplification of target DNA by the Polymerase Chain Reaction (PCR) and nucleic acid hybridization for the detection of 14 high-risk (HR) HPV types in a single ana
During an internal investigation, a formulation error that occurred was identified during the manufacture of the cobas¿ 4800 HPV Master Mix reagent that was packaged in four (4) cobas¿ 4800 AMP/DET kits, US- and CE-IVD (240 and 960 test kit configurations). Examination of the batch production record of the material revealed there was an error in the tare weight used for the carboy during the fina
- 2013-09-17CPSCThe Children's Place, of Secaucus, N.J.The Children's Place Recalls Footed Pajamas Due to Violation of Federal Flammability Standard
The footed pajamas fail to meet the federal flammability standard for children's sleepwear, posing a burn hazard to children. The garments are being recalled because they do not meet the tight-fitting sizing requirements.
- 2013-09-11CPSCHachette Book Group, Inc., New York, N.Y.Hachette Book Group Recalls Children's Books Due To Choking and Laceration Hazards
A metal rod holding small beads on the cover of books can detach and release small parts that present a choking hazard. A detached metal bar can expose a sharp edge posing a laceration hazard.
- 2013-09-11CPSCCambridge Metals & Plastics, a Division of Water Works Manufacturing Inc., of Cambridge, Minn.Cambridge Metal & Plastics Recalls Motorcycle Training Wheels Due to a Crash Hazard
Bolts and nuts securing the wheel can loosen and cause the rider to lose control, posing a crash hazard.
- 2013-09-10CPSCBe Amazing! Toys, of Salt Lake CityBe Amazing! Toys Recalls Monster Science Growing Spiders Due to Serious Ingestion Hazard
The soft and colorful product can be mistaken by a child for candy. When the marble-sized toy is ingested, it can expand inside a child's body and cause intestinal obstructions, resulting in severe discomfort, vomiting, dehydration and could be life threatening. The toys do not show up on an x-ray and need surgery to be removed from the body.
- 2013-09-10CPSCEco-Novelty Corp., of Troy, Mich.Eco-Novelty Recalls Jumbo Size and Jumbo Multipurpose Cosmo Beads Toys Due to Serious Ingestion Hazard
The hard and colorful toy can be easily mistaken for candy by a child. When the bead is ingested, it expands and can cause intestinal obstructions inside a child's body, resulting in severe discomfort, vomiting, dehydration and could be life threatening. The toys need surgery to be removed from the body. Similar toys have not shown up on x-rays.
- 2013-09-04FDA-DeviceFresenius Medical Care Holdings, Inc. dba Renal SolutionsClass II2008 MeDS Pump, Venofer(R) Pump Product Usage: The 2008 MeDs pump is an optional accessory for use with the Fresenius 2008 Series Hemodialysis Machines and is intended to administer Venofer to treat iron deficiency anemia in patients with chronic kidney disease undergoing hemodialysis, where Venofer, in conjunction with hemodialysis, is prescribed by a physician.
Product is being recalled because the combination of the current 50 mg vial, the 2008 MeDS pump, and the 2008 MeDS pump tubing Set for CombiSet Bloodlines can lead to a situation where Venofer(R) delivery does not meet dosage accuracy requirements. This may lead to a slight over or under delivery of Venofer(R) that does not pose an acceptable risk to the patient. Please note that this recall
- 2013-09-04FDA-FoodHeeren Bros IncClass ICardboard BIN LABEL: 03808 LOT #: 09000101, MELON CANTALOUPE..., 80-90 CT , 07/22/13 cantaloupes themselves are not labeled.
Heeren Brothers Produce is recalling Athena cantaloupes distributed to small independent grocers in Michigan July 23-26, after routine testing by FDA found product contaminated with Listeria monocytogenes, an organism that can cause serious and sometimes fatal infections in young children, the elderly or others with weak immune systems. Healthy individuals may suffer short-term symptoms, such as
- 2013-08-29CPSCBuild-A-Bear Workshop Inc., of St. Louis, Mo.Build-A-Bear Recalls Stuffed Animal Toy Due to Choking Hazard
The stuffed animal's eye can detach, posing a choking hazard to young children.
- 2013-08-28FDA-FoodWhole Foods MarketClass ICrave Brothers Les Freres cheese sold with labeling as: Les Freres, Crave Brothers Les Freres, Les Freres Wash Rind Product of USA, Crave Bros Les Freres, Crave Brothers Les Freres Cheese by Pound, Les Freres Crave Brothers, and Les Freres Crave Brothers PO-RK. Cheese was cut and wrapped.
Whole Foods Market announces that it is recalling Crave Brothers Les Freres cheese in response to a recall by the Crave Brothers Farmstead Cheese Company of Waterloo, Wisconsin. The cheese is being recalled because it has the potential to be contaminated with Listeria monocytogenes, an organism which can cause serious and sometimes fatal infections in young children, frail or elderly people, and o
- 2013-08-28CPSCBaby Jogger® LLC, of Richmond, Va.Baby Jogger Recalls Car Seat Adaptors for Strollers Due to Fall Hazard
The car seat adaptor support bars can fail, posing a fall hazard to children.
- 2013-08-21FDA-DeviceTerumo Cardiovascular Systems CorporationClass IITerumo¿ Advanced Perfusion System 1: 220/240V AC, Advanced Perfusion System 1 The Terumo¿ Advanced Perfusion System 1 is indicated for use in extracorporeal circulation of blood for arterial perfusion, regional perfusion, and cardiopulmonary bypass procedures only when used by a qualified perfusionist who is experienced in the operation of Sarns " or similar equipment.
The operators manual does not fully describe the sequence of expected events that will occur when a specific operating condition exists. Specifically, if the user is adjusting the System 1 centrifugal pump speed via the Central Control Monitor at the same time an alarm condition occurs with configuration for a pump coast response, the labeling in the operators manual does not fully describe how the pump will react.
- 2013-08-21FDA-DeviceTerumo Cardiovascular Systems CorporationClass IITerumo¿ Advanced Perfusion System 1: 100/120V AC, Advanced Perfusion System 1 The Terumo¿ Advanced Perfusion System 1 is indicated for use in extracorporeal circulation of blood for arterial perfusion, regional perfusion, and cardiopulmonary bypass procedures only when used by a qualified perfusionist who is experienced in the operation of Sarns " or similar equipment.
The operators manual does not fully describe the sequence of expected events that will occur when a specific operating condition exists. Specifically, if the user is adjusting the System 1 centrifugal pump speed via the Central Control Monitor at the same time an alarm condition occurs with configuration for a pump coast response, the labeling in the operators manual does not fully describe how the pump will react.
- 2013-08-21FDA-DeviceMedtronic Inc. Cardiac Rhythm Disease ManagementClass IIMedtronic Affinity Pediatric Arterial Filter, model number S4014, sterilized using ethylene oxide. Recall Update 9/6/13: Medtronic, Red cross Infant Pack 1/B, South-Africa, REF M272403C, Sterile EO. The Affinity Pediatric Arterial Filters are single-use, sterile, nonpyrogenic devices designed to filter microemboli greater than the specified micron size from the circuit for periods up to 6 hours during cardiopulmonary bypass surgery. These devices are available both in an uncoated and a
Medtronic is recalling 148 Affinity Pediatric Arterial Filters from 2 manufacturing lots because a limited quantity of filters may have a small breach in the filter media that may allow unwanted particulate or gaseous emboli to pass through the filter and the outlet of the device, which could result in serious injury to a pediatric patient including neurological damage, or potential patient death.
- 2013-08-21FDA-DeviceCarefusion 2200 IncClass II1) Adult Manual Resuscitator, 2K8004, Oxygen Reservoir Bag, Adult Mask; 2) Adult Manual Resuscitator, 2K8005, 40" (1.0 m) Oxygen Reservoir Tubing, Adult Mask; 3) Adult Manual Resuscitator, 2K8017, Variable Volume Oxygen Reservoir Tubing, Adult Mask; 4) Adult Manual Resuscitator, 2K8034, 40" (1.0 m) Oxygen Reservoir Tubing, PEEP Valve, without Mask; 5) Adult Manual Resuscitator, 2K8035, Oxygen Reservoir Bag, PEEP Valve, Adult Mask; 6) Pediatric Manual Resuscitator, 2K8037, 40" (1.0 m) O
CareFusion has received four (4) customer reports of a component (oxygen connector) within the resuscitation bag being occluded which disables the flow of supplemental oxygen to the resuscitation bag and thus may pose a serious patient safety risk.
- 2013-08-21CPSCJiaxing Huayan Fashion Co. Ltd, of Jiaxing Zhejiang, ChinaHALO SleepSacks Wearable Blankets Recalled Due to Choking Hazard; Sold Exclusively at Babies R Us
Petals from the floral embellishment on the blankets can detach, posing a choking hazard to infants.
- 2013-08-20CPSCKlever Kids, of Washington, D.C.Children’s Pajamas Recalled by Klever Kids Due to Violation of Federal Flammability Standard
The pajamas fail to meet federal flammability standards for children's sleepwear, posing a risk of burn injuries to children.
- 2013-08-20CPSCApple Park LLC, of San FranciscoApple Park Recalls Children’s Loungewear Due to Violation of Federal Flammability Standard
The loungewear garments fail to meet children's sleepwear federal flammability standards which require sleepwear, including loungewear, to be either snug-fitting or flame resistant, posing a risk of burn injuries to children.
- 2013-08-15CPSCJP Boden Services Inc., of Pittston, Pa.JP Boden Recalls Children's Sandals Due to Fall Hazard (Recall Alert)
The cork sole can detach from the sandal and cause a child to trip and fall.
- 2013-08-14FDA-DeviceSiemens Healthcare Diagnostics, Inc.Class IIDimension Tacrolimus Flex reagent cartridge (DF107) and Dimension TACR CAL (DC107) Product Usage: The TACR method is an in vitro diagnostic test intended to quantitatively measure Tacrolimus in human whole blood on the Dimension clinical chemistry system. Measurements of Tacrolimus are used as an aid in the management of tacrolimus therapy in kidney and liver transplant patients.
Siemens initiated a recall due to confirmed complaints of low patient sample recovery with Dimension TACR Flex Reagent cartridge (DF107) lot BB4087 and its linked calibrator (DC 107) lot 3BD029. Falsely low Tacrolimus results across the assay range may lead to alterations in dosing.
- 2013-08-08CPSCHolgate Toy Division, of Pepperell Braiding Co Inc., of Pepperell, Mass.Holgate Toys Recalls Playmat Sets Due to Choking Hazard; Sold Exclusively at Wegmans Food Stores
The wheels on the wooden vehicles can detach, posing a choking hazard to young children.
- 2013-08-07FDA-FoodLipari Foods, Inc.Class IWHOLEY Shrimp, Farm Raised, Cooked, Peeled Deveined, Tail on, Ingredients: Shrimp, Salt and Sodium Tripolyphosphate..., ,Net Wt 1 LB (16 oz) , 399103 UPC Number: 094776074556; Product of Indonesia
Lipari Foods of Warren, MI is recalling Wholey peeled, cooked, tail-on 31/40 count shrimp, because it has the potential to be contaminated with Salmonella, an organism which can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems.
- 2013-08-07FDA-FoodKabco Pharmaceuticals, Inc.Class IIPERFECT 3000 VANILLA POWDER, FORMULA # 3101. The product is loose powder packaged in bulk drum.
Firm had distributed the bulk product in violation of the Consent Decree for Permanent Injunction (12-CV-3468).
- 2013-08-07FDA-FoodKabco Pharmaceuticals, Inc.Class IIPERFECT 3000 CHOCOLATE POWDER, FORMULA # 3098. The product is loose powder packaged in bulk drum.
Firm had distributed the bulk product in violation of the Consent Decree for Permanent Injunction (12-CV-3468).
- 2013-08-07FDA-FoodOzark Bottling, LLCClass IIILehman's Hot Veggie Mix, packaged in 12/16-oz jars per case, distributed by Lehman's, Kidron, OH 44636
The pH levels of these products are not accurately measured due to the use of outdated buffers and pH levels do not meet process specifications.
- 2013-08-06CPSCGlideaway Bed Carriage Manufacturing Company, of St. Louis, Mo.Sleepharmony Pink Youth Beds Recalled by Glideaway Due to Violation of Lead Paint Standard
The surface paint on the pink-colored youth beds contains levels of lead that exceed the limits allowed by law.
- 2013-07-31FDA-DeviceBecton Dickinson & Co.Class IIBBL Campylobacter CSM Agar (Charcoal-Based Selective Medium), Catalog # 299614, packaged in cartons of 20 plates, and labeled in part ***Becton, Dickinson and Company 7 Loveton Circle Sparks, MD 21152 USA 800-638-8663 www.bd.com/ds*** BCYE Selective with PAV is used in qualitative procedures for isolation of Legionella species from clinical specimen and nonclinical (environmental) samples. It is similar to the Edelstein formula, except that the concentration of polymyxin B is reduced by half
Microbiological identification media may exhibit reduced levels of Vancomycin.
- 2013-07-31FDA-DeviceBecton Dickinson & Co.Class IIBD BBL BCYE Selective Agar with PAV, Catalog # 297880, packaged in cartons of 10 plates, and labeled in part ***Becton, Dickinson and Company 7 Loveton Circle Sparks, MD 21152 USA 800-638-8663 www.bd.com/ds*** BCYE Selective with PAV is used in qualitative procedures for isolation of Legionella species from clinical specimen and nonclinical (environmental) samples. It is similar to the Edelstein formula, except that the concentration of polymyxin B is reduced by half, and vancomycin is subst
Microbiological identification media may exhibit reduced levels of Vancomycin.
- 2013-07-31CPSCZhejiang Xinyi Traveling, of Linhai City, ChinaFar East Brokers Recalls Ladybug-themed Kids’ Outdoor Furniture Due to Violation of Lead Paint Standard
The red surface paint on the furniture contains excessive levels of lead, a violation of the federal lead paint standard.
- 2013-07-31CPSCBe Amazing! Toys, of Salt Lake CityBe Amazing! Toys Recalls Monster Science and Super Star Science Colossal Water Balls Due to Serious Ingestion Hazard
The soft and colorful product can be easily mistaken by a child for candy. When the marble-sized toy is ingested, it can expand inside a child's body and cause intestinal obstructions, resulting in severe discomfort, vomiting, dehydration and could be life threatening. The toys do not show up on an x-ray and require surgery to be removed from the body.
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