Baby and kids' product recalls
6674 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.
- 2012-12-19FDA-DeviceQuasar Bio-Tech, Inc. dba Silver Bay LLCClass IIBaby Quasar (LAB-001-D, BQ101) and Baby Quasar Pink (LAB-046-A BQ101-P) are infrared LED lamps that are labeled in part: "***BABY QUASAR***FOR YOUTHFUL RADIANT SKIN***Skin Rejuvenating System with Sequepulse***Manufactured by: Silver Bay, LLC; Made in the USA, with highest quality components and durable aluminum. Five Year Warranty The product emits energy in the near infrared spectrum to provide topical heating for the purpose of elevating tissue temperature. This device may be used to pro
Quasar Bio-Tech is recalling their Baby Quasar, Baby Quasar Pink, Quasar Power Pack, and Quasar MD because the device is unapproved.
- 2012-12-19FDA-DeviceMedtronic NeuromodulationClass IMedtronic SynchroMed II, Model 8637, (The SynchroMed¿ II Pump is supplied in 20 ml or 40 ml reservoir size.) Sterilized using ethylene oxide. The pump is part of an infusion system that stores and delivers a prescribed drug to a specific site. The implantable components of the SynchroMed II Infusion System include the pump, catheter, and catheter accessories.
Medtronic notified Healthcare Professionals of the impact of unapproved drugs on the performance of the SynchroMed infusion pump system. Use of unapproved drugs with SynchroMed pumps can result in an increased risk of permanent motor stall and cessation of drug infusion. UPDATE 2/1/2016: Medtronic received approval to incorporate enhancements to the SynchroMed II pump which decreases the potential for internal electrical shorting and motor corrosion, and is retrieving any unused pumps.
- 2012-12-19FDA-DeviceHospira Inc.Class IIPlum A+ Single Channel Infusion Pumps with Hospira Mednet Software and a Connectivity Engine peripheral module that provides wired Ethernet and wireless local area networking, allowing the MedNet software to download drug libraries to the infuser and enable the auto-programming feature; Hospira, Inc., Lake Forest, IL 60045; pump list #20679 and 20792, module list number 20677. The Plum A+ Infusion System with Hospira MedNet Software and a Connectivity Engine peripheral module that provides wi
The volume control knob on some Plum A+ single channel infusers (located on the back of the infuser) may not function as described in the System Operating Manual - the direction for Loud and Quiet may be reversed. The manual indicates a clockwise rotation of the knob decreases the volume; however, on some of the devices the alarm volume increases when the knob is turned clockwise.
- 2012-12-19FDA-DeviceHospira Inc.Class IIPlum A+ Hyperbaric Single Channel Infusion Pumps with Hospira MedNet Software and a Connectivity Engine peripheral module that provides wired Ethernet and wireless local networking, allowing the MedNet software to download drug libraries to the infuser and enable the auto-programming feature; Hospira, Inc., Lake Forest, IL 60045; pump list number 11005, module list number 11006 Product Usage: The Plum A+ Hyperbaric Infusion System is exclusively designed for hyperbaric therapy in monospace
The volume control knob on some Plum A+ single channel infusers (located on the back of the infuser) may not function as described in the System Operating Manual - the direction for Loud and Quiet may be reversed. The manual indicates a clockwise rotation of the knob decreases the volume; however, on some of the devices the alarm volume increases when the knob is turned clockwise.
- 2012-12-19FDA-DeviceHospira Inc.Class IIPlum A+ Single Channel Infusion Pumps with Plug-and-Play Modules that provide wired Ethernet and wireless local area networking; Hospira, Inc., Lake Forest, IL 60045; pump list number 11971, module list numbers 12101, 12102 and 12393; pump list number 11973, module list number 12380; pump list number 12391, module list numbers 12097 and 12680 Product Usage: The Plum A+ Infusion System is a dual-line volumetric infusion pump that provides precise delivery of multiple i.v. therapies across the
The volume control knob on some Plum A+ single channel infusers (located on the back of the infuser) may not function as described in the System Operating Manual - the direction for Loud and Quiet may be reversed. The manual indicates a clockwise rotation of the knob decreases the volume; however, on some of the devices the alarm volume increases when the knob is turned clockwise.
- 2012-12-19FDA-FoodElla's KitchenClass IIIElla's Kitchen yum yummy apple + ginger baby cookies Net Wt. 3.8 oz (108 g) Ella's Daddy's Company Ella's Kitchen Inc. Montclair, NJ 07042 UPC 845901000533 packaged in a chipboard carton with 12 cookies per box
Cookies may contain mold.
- 2012-12-19FDA-FoodElla's KitchenClass IIIElla's Kitchen yum yummy milk + vanilla baby cookies Net Wt. 3.8 oz (108 g) Ella's Daddy's Company Ella's Kitchen Inc. Montclair, NJ 07042 UPC 845901000526 packaged in a chipboard carton with 12 cookies per box
Cookies may contain mold.
- 2012-12-19FDA-FoodBaugher Enterprises, IncorporatedClass IBaugher's Apple Cider, one gallon and half gallon plastic jugs, with plastic caps labeled in part ***Fresh*** Preservatives added-keep under refrigeration***. Jugs are labeled in part ***FDA Required Warning: This product has not been pasteurized and therefore may contain harmful bacteria that can cause serious illness in children, the elderly, and persons with weakened immune systems***.
An unpasteurized apple cider product is potentially linked to foodborne illnesses in cases confirmed with E. coli 0157:H7.
- 2012-12-19FDA-FoodLin-Mar Partners IncClass ILonghorn Bar Peanut Butter Trail Mix (1.80 oz), 144 units per case. The bars are in packaging labeled as Longhorn Bars and have a picture of roasted peanuts and trail mix.
LIN-MAR PARTNERS, INC of Austin, Texas recalled two varieties of Longhorn Bars: Roasted Peanut with Chocolate Energy Bars and Peanut Butter Trail Mix Protein Bars, because they have 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. Healthy person
- 2012-12-19FDA-FoodLin-Mar Partners IncClass ILonghorn Bar Roasted Peanut with Chocolate (1.23 oz), 144 units per case. The bars are in packaging labeled as Longhorn Bars and have a picture of roasted peanuts and chocolate.
LIN-MAR PARTNERS, INC of Austin, Texas recalled two varieties of Longhorn Bars: Roasted Peanut with Chocolate Energy Bars and Peanut Butter Trail Mix Protein Bars, because they have 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. Healthy person
- 2012-12-12FDA-DeviceNatus Medical IncorporatedClass IThe product has the Catalogue/Part number 60010. Olympic Cool-Cap System is a selective head cooling system for treatment of hypoxic-ischemic encephalopathy (HIE) in infants. A cooling water cap is placed on the infant's head and the body is warmed using radiant warmers. The Cool-Cap provides 72 hours of monitored cooling. The device is labeled in parts: "***OLYMPIC COOL-CAP Cooling Unit***Natus Medical Incorporated 5900 First Avenue South ***Made in USA***Control Unit Model No. 60010**
The Olympic Cool-Cap's Control Module has experienced a frozen screen during use. When this occurs, the on-screen information remains on display, but the system is no longer providing cooling treatment to the infants. The visible clock displayed at the upper right hand corner of the screen stops advancing.
- 2012-12-12CPSCBaby Jogger LLC, of Richmond, Va.City Versa Strollers Recalled by Baby Jogger Due to Fall Hazard
The stroller frame can fail to lock in place and collapse while in use, posing a fall hazard to children in the stroller.
- 2012-12-10CPSCGlobal Goler Co. Limited, of Guangdong, ChinaHigh-Powered Magnet Sets Recalled by Reiss Innovations Due to Ingestion Hazard; Sold Exclusively on Amazon.com
When two or more magnets are swallowed, they can link together inside a child's intestines and clamp onto body tissues, causing intestinal obstructions, perforations, sepsis and death. Internal injury from magnets can pose serious lifelong health effects.
- 2012-12-06CPSCDream On Me Inc., of South Plainfield, N.J.Dream On Me Recalls Bath Seats Due to Drowning Hazard
The bath seats fail to meet federal safety standards, including the requirements for stability. Specifically, the bath seats can tip over, posing a risk of drowning to babies.
- 2012-12-06CPSCDream On Me Inc., of South Plainfield, N.J.Dream On Me Recalls Children's Bed Rails Due to Suffocation and Strangulation Hazards
The bed rail can separate from the mattress allowing a child's body to become entrapped if it slips between the rail and the mattress. This poses suffocation and strangulation hazards to children.
- 2012-11-28FDA-DeviceOrthoPediatrics CorpClass II4.5mm PLEO Osteotomy Guide. OrthoPediatrics Corp. markets a pediatric, extension osteotomy bone plate system. This system is marketed under the brand name OrthoPediatrics PediLock Extension Osteotomy Plate ( PLEO ). The product included in this recall is a Class I, 4.5mm PLEO Osteotomy Guide Instrument, common name: Guide, Surgical, Instrument. The PediLoc¿ Extension Osteotomy Plate is part of the OrthoPediatrics~PediLoc¿ system. The PediLoc¿ Extension Osteotomy Plate consists of 3.5mm and 4.
Complaint received from sales representative that the drill guide tubes would not screw into replenishment instrument. Upon investigation, it has been determined that the device was not manufactured to design specifications and will not function as intended.
- 2012-11-28FDA-DeviceKing Systems Corp.Class IIKING LAD Flexible ClearSeal SINGLE USE, King Systems ETO Sterilie, 10 devices/case "Size 3 / Child ClearSeal Flexible King LAD¿ Patient Size: 30-50kg " Product Usage: Laryngeal airway
The firm received two complaints from a user facility in New Jersey regarding color-coded EtO sterilization indicators on the primary device packaging that did not undergo the expected color change. The complainant reported devices that had pink color indicators when the product packaging specified that the color should change from pink to yellow (or brown) if the product had subjected to an EtO
- 2012-11-28FDA-DeviceKing Systems Corp.Class IIKING LAD Standard ClearSeal SINGLE USE, King Systems ETO Sterilie, 20 devices/case Size 2 / Infant ClearSeal Flexible King LAD¿ Patient Size: 10-20kg Product Usage: Laryngeal airway
The firm received two complaints from a user facility in New Jersey regarding color-coded EtO sterilization indicators on the primary device packaging that did not undergo the expected color change. The complainant reported devices that had pink color indicators when the product packaging specified that the color should change from pink to yellow (or brown) if the product had subjected to an EtO
- 2012-11-28FDA-DeviceKing Systems Corp.Class IIKING LAD Standard ClearSeal SINGLE USE, King Systems ETO Sterilie10 devices/case Size 3 / Child ClearSeal King LAD¿ Patient Size: 30-50kg Product Usage: Laryngeal airway
The firm received two complaints from a user facility in New Jersey regarding color-coded EtO sterilization indicators on the primary device packaging that did not undergo the expected color change. The complainant reported devices that had pink color indicators when the product packaging specified that the color should change from pink to yellow (or brown) if the product had subjected to an EtO
- 2012-11-28FDA-DeviceKing Systems Corp.Class IIKING LAD SILI CONE SINGLE USE, King Systems, 10 devices/case, ETO Sterile Size 3 / Child Silicone King LAD¿ Patient Size: 30-50kg Product Usage: Laryngeal airway
The firm received two complaints from a user facility in New Jersey regarding color-coded EtO sterilization indicators on the primary device packaging that did not undergo the expected color change. The complainant reported devices that had pink color indicators when the product packaging specified that the color should change from pink to yellow (or brown) if the product had subjected to an EtO
- 2012-11-28FDA-DeviceKing Systems Corp.Class IIKING LAD SILI CONE SINGLE USE, King Systems devices/case, ETO Sterile. Size 2 / Infant Silicone King LAD¿ Patient Size: 10-20kg Product Usage: Laryngeal airway
The firm received two complaints from a user facility in New Jersey regarding color-coded EtO sterilization indicators on the primary device packaging that did not undergo the expected color change. The complainant reported devices that had pink color indicators when the product packaging specified that the color should change from pink to yellow (or brown) if the product had subjected to an EtO
- 2012-11-28FDA-DrugChurch & Dwight IncClass IIOrajel Kids My Way! Anticavity Fluoride (sodium fluoride) toothpaste, 0.24%, 3 oz (85 g) pump, Church & Dwight Col, Inc., Princeton, NJ 08543; UPC 3 10310 32370 7.
CGMP Deviations: Product was made with an incorrect ingredient, Laureth-9 was mistakenly substituted for PEG.
- 2012-11-28CPSCSportspower Ltd., of Hong KongSportspower Recalls Children’s Waterslides Due to Injury Hazard; Sold Exclusively at Menards
The warning labels on the children's waterslide are inadequate for weight limit and fail to tell consumers never to slide head first. This poses a risk of serious injuries to consumers, including neck injuries.
- 2012-11-28CPSCSportspower Ltd., of Hong KongTrampolines Recalled by Sportspower Due to Injury Hazard; Sold Exclusively at Sports Authority
The trampoline's metal legs can move out of position and puncture the jumping area, posing a risk of injury, including deep, penetrating puncture wounds, cuts and bruises to children and adults on the trampoline.
- 2012-11-27CPSCThe Step2 Company LLC, of Streetsboro, OhioChildren's Riding Toy Recalled by Step2 Due to Fall Hazard
Children who lean too far forward on the seat can go over the handle bar and hit the ground. This poses a fall hazard.
- 2012-11-21FDA-DrugStat Rx USAClass IIITobramycin Ophthalmic Oint., 0.3%, 5ml bottle, (Generic for: Tobrex), Rx only, Sterile, Mfg By Akorn, Inc., Lake Forest, IL 60045, NDC 16590-224-05,
Labeling: Label Mix-up: The affected units were labeled incorrectly describing the product as "ointment" instead of "solution."
- 2012-11-21CPSCHunter Douglas Fabrication Co., of West Sacramento, Calif.Hunter Douglas Recalls to Repair Custom Cellular and Pleated Window Coverings Due to Strangulation Hazard
Some of the cords inside the breakaway cord stop were tied in a single knot which can prevent the cord stop from functioning as designed to break away. A child can become entangled in a cord loop and strangle.
- 2012-11-21CPSCNingbo Golden Time Gifts and Crafts, of ChinaJo-Ann Fabric and Craft Recalls Foam Pumpkin Turkey Craft Kit Due to Risk of Magnet Ingestion Hazard
Magnets holding the pumpkin shell pieces together can become loose, posing an ingestion hazard to young children. If swallowed, these magnets can link together inside a child's intestines and clamp onto body tissues, causing intestinal obstructions, perforations, sepsis and death. Internal injury from magnets can pose serious lifelong health effects.
- 2012-11-20CPSCCatalogo S.A.C., of Lima, PeruGirl's Pajamas Recalled by Elephantito 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.
- 2012-11-20CPSCJ.P. Boden & Co. Ltd., of the United KingdomChildren's Pajamas Recalled by Boden Due to Violation of Federal Flammability Standards
The pajamas fail to meet federal flammability standards for children's sleepwear, posing a risk of burn injuries to children.
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