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.
- 2015-08-12FDA-FoodMedOp Health, Inc.Class III***MaxiFlex (Registered)***Multinutrient Formula***Maximum Joint Support***MedOp, Inc.***Dietary Supplement ***120 Vegetable Capsules***Distributed by MedOp, Inc., Oldsmar, FL 34677***www.medop.com***.
Maxivision MaxiFlex (Registered) Multinutrient Formula, 120 Vegetable Capsules is being recalled because a material review was conducted in April 2015. It revealed some of the Chondroitin Sulfate (Lot 093011 1031) raw material used in the manufacture of Maxiflex Multinutrient Formula Lot 32171215 was Out of Specification.
- 2015-08-12CPSCFlowers By Zoe, Melville, NYFlowers By Zoe Recalls Girls Striped Hoodie and Neon Tie Dye Jacket Due to Strangulation Hazard
The hoodies and jackets have drawstrings around the neck area which pose a strangulation hazard to children. Drawstrings can become entangled or caught on playground slides, hand rails, school bus doors or other moving objects, posing a significant strangulation and/or entanglement hazard to children.
- 2015-08-11NHTSA-EquipmentBritax Child Safety, Inc.Britax Child Safety, Inc. — Harness Adjuster/Release Button may Stick
If the harness loosens, the child may not be properly restrained, increasing their risk of injury in the event of a crash.
- 2015-08-06CPSCThe Children's Place Services Company LLC, of Secaucus, N.J.The Children's Place Recalls Boys' Varsity Jackets Due to Choking Hazard
The metal snaps on the jackets could detach, posing a choking hazard to young children.
- 2015-08-06CPSCSanMar Corp., of Issaquah, Wash.Precious Cargo Recalls Infant One-Piece Garments Due to Choking Hazard
The snaps on the one-piece garments can detach, posing a choking hazard to young children.
- 2015-08-05FDA-DeviceSynthes (USA) Products LLCClass IISynthes TI Matrix Pre-Bent Maxillary Plate / 2mm ADVMNT/0.8mm THK/L and Synthes TI Matrix Pre-Bent Maxillary Plate / 2mm ADVMNT/0.8mm THK/R. The Synthes Matrix ORTHOGNATHIC Fixation System is intended for use in selective trauma of the midface and craniofacial skeleton; craniofacial surgery; reconstructive procedures; and selective orthognathic surgery of the maxilla, mandible and chin in adults and children.
The affected part and lot numbers of the TI Matrix Pre-Bent Maxillary Plates may potentially have the incorrect laser etch denoting the orientation.
- 2015-08-05FDA-DeviceHamilton Medical, Inc.Class IIHamilton-G5 Ventilators with software versions V2.40/2.41 Catalog numbers for G5: 159001 and 159002. Software: 159700.. Intensive care ventilation of adult and pediatric patients and optionally infant and neonatal patients.
Customer reports that the ventilator display can freeze. Ventilation continues but the information is no longer displayed on the screen and the user can no longer operate the device.
- 2015-08-05CPSCDisney Store USA, LLC, of Pasadena, Calif.Disney Store Recalls Pencil Cases Due to Ingestion Hazard (Recall Alert)
The two magnets holding the pencil case lid closed can detach, posing an ingestion hazard. When these two magnets are swallowed, they can link together inside a child's intestines and result in serious internal injuries.
- 2015-08-05CPSCMZB, of Long Island City, N.Y.MZB Recalls Children's Watches Due to Risk of Skin Irritation
The case-back of the watch can detach and expose the interior to water, posing a risk of skin irritation, redness, rashes or chemical burns.
- 2015-08-04CPSCManhattan Group LLC, of Minneapolis, Minn.Manhattan Group Recalls Children’s Elephant Activity Toys Due to Choking Hazard
The wooden ring can break into small pieces, posing a choking hazard to young children.
- 2015-07-31USDAPublic Health AlertCheck whole pigs for Salmonella contamination
Product Contamination
- 2015-07-30CPSCStork Craft Manufacturing USA Inc., of Las Vegas, Nev.Stork Craft Recalls Crib Mattresses Due to Violation of Federal Mattress Flammability Standard
The crib mattresses fail to meet the mandatory federal mattress flammability standard for open flames, posing a fire hazard.
- 2015-07-29FDA-DeviceMermaid Medical A/SClass IIMermaid Medical M-Biopsy Coaxial Introducer Needle, Coaxial Needle for M-Biopsy 18Gx10cm-PRO-MAG, RX Only. Single packed device in a tyvek pouches. 10 single packed devices in a white carton unit box. The M-Biopsy coaxial needle is used to obtain one or multiple core samples from soft tissue such as the liver, kidney, prostate, breast, etc. and is to be used in conjunction with an M-Biopsy Biopsy Needle for a Bard Magnum or Pro-Mag Biopsy Instrument.
Mermaid Medical A/S is recalling some of their M-Biopsy Coaxial Introducer Needles because of the potential for small plastic pieces to be present in the luer of the cannula.
- 2015-07-29FDA-DeviceCooperSurgical, Inc.Class IIInfant Heel Warmer and Infant Gel Warmer, sold under the brand names CooperSurgical and Fisher brand as follows : CooperSurgical PN 20418 WARMGEL INFANT HEEL WARMER - PRISM BOX OF 100; PN 24401 LIQUID INFANT HEEL WARMER - PRISM BOX OF 100; and Fisher Brand. PN 24647 FISHERBRAND GEL INFANT - HEEL WARMER BOX OF 100; PN 24646 FISHERBRAND LIQUID INFANT - HEEL WARMER- 100 PER BOX
Product marketed without a 510(k)
- 2015-07-29FDA-DeviceStryker Instruments Div. of Stryker CorporationClass IIStryker SelectCore Variable Throw Biopsy Device, 14G, 10CM Product Usage: The Stryker SelectCore Variable Throw Biopsy Device is used in obtaining biopsy samples from soft tissues such as liver, breast, kidney, prostate, spleen, lymph nodes, and various soft tissue tumors. For breast biopsy this product is for diagnosis onlynot therapeutic use.. These devices are sterile, single use devices.
Stryker Instruments is recalling the Stryker SelectCore Variable Throw Biopsy Device due to the potential for for the stylet to eject from the SelectCore device during actuation.
- 2015-07-29FDA-DeviceWestern / Scott Fetzer CompanyClass IVarious OxyTOTE Portable Oxygen System regulators, Valve Integrated Pressure Regulator, one unit per package. Product Usage: Used to dispense Oxygen at prescribed flow rates to patients for therapeutic purposes and is designed to provide mobility with a self-contained supply of Oxygen.
The firm has become aware of the possibility of ignition and rupture (explosion) of a compressed gas oxygen cylinder, which can cause serious injury and/or death.
- 2015-07-28CPSCKyber Outerwear USA Corp., of Ogdensburg, NYKyber Outerwear Recalls Children’s Sweaters Due to Strangulation Hazard
The sweaters have a drawstring around the neck area that poses a strangulation hazard to children. Drawstrings can become entangled or caught on playground slides, hand rails, school bus doors or other moving objects, posing a significant strangulation and/or entanglement hazard to children.
- 2015-07-23CPSCPolaris Industries Inc., of Medina, Minn.Polaris Recalls Youth RZR Recreational Off-Highway Vehicles Due to Fire Hazard (Recall Alert)
The vehicle's fuel pump retaining ring can leak, posing a fire hazard.
- 2015-07-23CPSCUPPAbaby, of Hingham, Mass.UPPAbaby Recalls Strollers and RumbleSeats Due to Choking Hazard
The strollers' and RumbleSeats' bumper bar poses a choking hazard when a child bites the bumper bar and removes a piece of the foam covering.
- 2015-07-22FDA-DeviceElekta, Inc.Class IIMOSAIQ Oncology Information System MOSAIQ is an oncology information system used to manage workflows for treatment planning and delivery. It supports information flow among healthcare facility personnel and can be used wherever radiotherapy and/or chemotherapy are prescribed.
A problem exists in MOSAIQ resulting in the incorrect field size being sent to the treatment machine for stereotactic plans using cones.
- 2015-07-16CPSCReliance Worldwide Corp. of Atlanta, Ga.Reliance Worldwide Recalls Cash Acme Heatguard Temperature Actuated Flow Reducing (TAFR) Devices Due to Scald Hazard
The thermal element in the TAFR can fail to operate, causing the users to come in contact with water that is hotter than expected. This poses a risk of scalding injury.
- 2015-07-15CPSCBexco Enterprises Inc., of Montebello, Calif.Bexco Recalls DaVinci Brand Cribs Due to Entrapment, Fall and Laceration Hazards
A metal bracket that connects the mattress support to the crib can break, creating an uneven sleeping surface or a gap. If this occurs, a baby can become entrapped in the crib, fall or suffer lacerations from the broken metal bracket.
- 2015-07-15USDAClass IDiscard Aspen Foods frozen breaded chicken
Product Contamination
- 2015-07-12USDAClass IBarber Foods Recalls Stuffed Chicken Products Due To Possible Salmonella Enteritidis Contamination
Product Contamination
- 2015-07-08FDA-DeviceHamilton Medical, Inc.Class IIHamilton Medical Infant Flow Sensor, single use, (3.1m), Part number 260179. The infant flow sensor is an accessory for the Hamilton Medical Ventilators. Product Usage: The infant flow sensor is a device to measure patient air flow and pressures within the Hamilton Medical Ventilators.
An issue has been discovered with the Hamilton Medical Infant Flow Sensor, single use. When a ventilation mode with adaptive volume control (APVcmv/CMV+) is used, the ventilator may adjust the ventilation on the inaccurate flow measurement and decrease the amount of ventilation delivered.
- 2015-07-08FDA-DeviceHamilton Medical, Inc.Class IIHamilton Medical Infant Flow Sensor, single use, (1.88m), Part number 155500. The infant flow sensor is an accessory for the Hamilton Medical Ventilators. Product Usage: The infant flow sensor is a device to measure patient air flow and pressures within the Hamilton Medical Ventilators.
An issue has been discovered with the Hamilton Medical Infant Flow Sensor, single use. When a ventilation mode with adaptive volume control (APVcmv/CMV+) is used, the ventilator may adjust the ventilation on the inaccurate flow measurement and decrease the amount of ventilation delivered.
- 2015-07-08FDA-DeviceHamilton Medical, Inc.Class IIHamilton Medical Infant Flow Sensor, single use, (1.6m), Part number 260177. The infant flow sensor is an accessory for the Hamilton Medical Ventilators. Product Usage: The infant flow sensor is a device to measure patient air flow and pressures within the Hamilton Medical Ventilators.
An issue has been discovered with the Hamilton Medical Infant Flow Sensor, single use. When a ventilation mode with adaptive volume control (APVcmv/CMV+) is used, the ventilator may adjust the ventilation on the inaccurate flow measurement and decrease the amount of ventilation delivered.
- 2015-07-08FDA-FoodSnoqualmie Gourmet Ice CreamClass IIce Cream products, total 177 different flavors. Products sold under brand names such as Emerald & Spruce, Snoqualmie, and Top Pot. Products are packaged in various sizes as described below: 1 gallon horizontal Tray; 1.5 gallon Tub; 4.69 oz. single serve Cup; 16 oz. carton Pint; 3 gallon plastic Tub. THE LIST OF 177 FLAVORS: 1/2 Spumoni 4 Color Spumoni Almond Poppy Seed Almond Rocha Amaretto Hazelnut Apple Apple Cider Apple Crisp Apple Fritter Apple Pie Bailey's Irish C
All 177 flavors ice cream products are being recalled due to the potential to be contaminated with Listeria monocytogenes.
- 2015-07-08FDA-DrugLincare, Inc.Class IITPN 3:1, 1844 mL Bags, Qty: 6, Base Formula Sodium Chloride, Dextrose 70%, Clinisol SF 15%, Intralipid 20%, Water for Inj; Electrolytes KCL, Ca Gluconate, MgSO4, K Phos; Vitamins, trace elements and medications Multitrace-4, Multi Vitamin, Rx Only. Compounded by: United Medical IV Center (Little Rock) 1527 South Bowman Rd. Ste. D Little Rock, AR 72211-4200 501-227-0900.
Lack of Assurance of Sterility: Sterility of product is not assured.
- 2015-07-08FDA-DrugLincare, Inc.Class IITPN 3:1, 1090 mL Bags, Qty: 7, Base Formula Dextrose 70%, Travasol 10%, Intralipid 20%, Water for Inj; Electrolytes K Phos, KCL, MgSO4, NaCl, Ca Gluconate, Rx Only. Compounded by: United Medical IV Center (Little Rock) 1527 South Bowman Rd. Ste. D Little Rock, AR 72211-4200 501-227-0900.
Lack of Assurance of Sterility: Sterility of product is not assured.
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