Baby and kids' product recalls
6673 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.
- 2015-01-14FDA-DeviceOrthovita, Inc., dBA Stryker Orthobiologics.Class IIStryker Orthobiologics Imbibe Aliquot Needle Bone Cement Needle- Model Numbers: 2110-0505 Beveled Needle, 11 gauge x 4 inch 2110-0524 Beveled Needle, 11 gauge x 6 inch 2110-0506 Diamond Needle, 11 gauge x 4 inch 2110-0529 Diamond Needle, 11 gauge x 6 inch Intended Use: Can be used in either direct (or open) and percutaneous (or deep) delivery of bone cement.
There is the potential for a breach in the inner or outer packaging pouches of all lots of the Stryker Orthobiologics Imbibe Aliquot Needle Bone Cement Needle.
- 2015-01-14FDA-DrugRight Value Drug Stores, Inc.Class IIGlutathione 200 mg/mL Injectable, packaged in a) 5 mL MDV (multiple dose vials), b) 30 mL MDV (multiple dose vials), and c) 100 mL MDV (multiple dose vials), Rx only, Carie Boyd's Prescription Shop, 122 Grapevine Highway, Hurst, TX 76054, (817) 282-9376.
Incorrect Product Formulation: An incorrect gas was used to remove the oxygen from the vial.
- 2015-01-13CPSCIKEA North America Services LLC, of Conshohocken, Pa.IKEA Recalls Crib Mattresses Due to Risk of Entrapment
The crib mattresses could create a gap between the mattress and crib ends larger than allowed by federal regulations, posing an entrapment hazard to infants.
- 2015-01-12USDAClass IDiscard US Foods beef fajita strips
Misbranding, Unreported Allergens
- 2015-01-09USDAClass IDo not eat Shirki's Meat pork sausage
Misbranding, Unreported Allergens
- 2015-01-08CPSCStar Ride Kids, of New York. N.Y.Children’s Pajamas Recalled by Star Ride 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.
- 2015-01-07FDA-FoodOverhill Farms IncClass IOpen Nature Chile Cheese Enchilada Two enchiladas filled with a queso fundido cheese mix topped with guajillo sauce and Mexican cheeses KEEP FROZEN COOK THOROUGHLY NET WT 9 OZ (255 g) COOKING INSTRUCTIONS FOR FOOD SAFETY, FOLLOW THESE COOKING INSTRUCTIONS. PRODUCT NEEDS TO BE THOROUGHLY COOKED. MICROWAVE OVEN (preferred method (Cook from frozen) 1. Remove tray from outer package and pierce film 3-4 times to vent. 2. Cook on HIGH 3 minutes. 3. Pull back film and stir sauce al
A recall notice from High Quality Organics (HQO) recalling their organic Cilantro, used in the product, which 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. Healthy people infected with Salmonella should monitor themselves for some or all o
- 2014-12-31FDA-DeviceSiemens Healthcare Diagnostics, Inc.Class IIDimension Vista 500 Intelligent Lab System or Dimension Vista 1500 Intelligent Lab System: An in vitro diagnostic device intended to duplicate manual analytical procedures such as pipetting, mixing, heating, and measuring spectral intensities to determine a variety of analytes in human body fluids.
Customer complaints of discrepant flagged and/or un-flagged patient and QC results. Reagent probe performance may decline more quickly than anticipated and have an effect on assays with similar formulations when processed sequentially on the same reagent server.
- 2014-12-31FDA-DeviceHeart Sync, Inc.Class IADULT/CHILD Radiotranslucent Electrode, Part number T100AC-PHILIPS, Rx ONLY, For use with Philips HeartStart AED "Comparable to Philips Medical HeartStart Electrodes Plug Style Connector", Intended for use during defibrillation, cardioversion, pacing, and ECG monitoring, Single use.
Heart Sync Multi-function defibrillation electrodes will not connect with Philips FR3 or FRx AED units. The FRx AED unit requires the pads to be pre-connected, and will issue a continuous alarm chirp to alert the user that the proper pads are not connected to the unit prior to use. The FR3, however, does not require pre-connection and the user may not discover the incompatibility issue until the
- 2014-12-31FDA-DeviceHeart Sync, Inc.Class IADULT/CHILD Radiotransparent Electrode, Part number C100AC-PHILIPS, Rx ONLY, For use with Philips HeartStart AED "Comparable to Philips Medical HeartStart Electrodes Plug Style Connector", Intended for use during defibrillation, cardioversion, pacing, and ECG monitoring, Single use.
Heart Sync Multi-function defibrillation electrodes will not connect with Philips FR3 or FRx AED units. The FRx AED unit requires the pads to be pre-connected, and will issue a continuous alarm chirp to alert the user that the proper pads are not connected to the unit prior to use. The FR3, however, does not require pre-connection and the user may not discover the incompatibility issue until the
- 2014-12-31FDA-FoodCoca-Cola Company (The)Class IIICoca Cola Zero, 2 liter pet bottle, UPC 49000 05014, The Coca Cola Company
Equipment malfunction led to ingredients to be blended at levels that are inconsistent with approved formulations.
- 2014-12-31USDAClass IDon't eat Harris Teeter chicken soup
Misbranding, Unreported Allergens
- 2014-12-24FDA-DeviceStryker EndoscopyClass IIPKG, BABY METZENBAUM SCISSORS, CURVED, P/N 0250080028. Laparoscopic Manual Instruments are intended for cutting, holding, grasping and manipulating of tissue, organs, organ areas and surgical auxiliaries such as suturing material. Some instruments have radio frequency (RF) ports which allow them to be used for electrosurgery. Laparoscopic surgical manual instruments are designed to be used endoscopically through cannulae to perform cutting, grasping, dissecting, retracting, and manipulating fu
The parameters provided in the Laparoscopic Manual Instruments Instructions for Use (IFU 1000-401-070 Revision G or prior) do not support the unwrapped Gravity cycle and the Ethylene Oxide cycle sterilization methods
- 2014-12-24FDA-FoodNBTY, Inc.Class ISOLGAR ENHANCED SERIES ABC DOPHILUS POWDER FOR INFANTS AND CHILDREN, NET WT. 1.75 oz (50 g), UPC 0 33984 00010 0. Carefully Manufactured by: Solgar, Inc., 500 Willow Tree Road Leonia, NJ 07605 U.S.A.
NBTY has recalled ABC Dophlius Powder due to the presense of Rhizopus oryzae fungi.
- 2014-12-22CPSCThe James Trading Group, Orangeburg N.Y.James Trading Group Recalls Croker Kids Fleece Panel Hoodie Due to Strangulation Hazard (Recall Alert)
The sweatshirts have a drawstring around the neck area which 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.
- 2014-12-19CPSCComfort Research, LLC, of Grand Rapids, Mich.Comfort Research Recalls Vinyl Bean Bag Chairs Due to Risk of Entrapment, Suffocation
The zippers on the bean bag chairs can be opened by children who can then crawl inside, become entrapped, suffocate or choke on the bean bag chair's foam beads.
- 2014-12-19CPSCBRP U.S. Inc., of Sturtevant, Wis.BRP Recalls Ski-Doo and Can-Am Kids’ Hoodies Due to Strangulation Hazard
The hoodies have a drawstring around the neck area which 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.
- 2014-12-18CPSCKiddie Korral, Dallas, TXKiddie Korral Recalls Girls Hoodies with Ponies Due to Strangulation Hazard
A drawstring through the hood of the hoodies can 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.
- 2014-12-18CPSCGiggles International Ltd., of Hong KongGiggles International Recalls Animated Monkey Toy Due to Burn Hazard; Sold Exclusively at Cracker Barrel Old Country Stores
The battery compartment can reach temperatures up to 230 degrees Fahrenheit, posing a burn hazard.
- 2014-12-17FDA-DeviceInstrumed International, Inc.Class IIA circumcision clamp is an instrument used to compress the foreskin of the penis during circumcision of a male infant sold under the Medline Industries, Boss Instruments, Millennium Surgical, Medetz Surgical, Surgical Direct, Surgipro, Teleflex Medical, Boss Instruments, Symmetry Surgical, Phoenix Instruments, GICAL, and CareFusion brand names.
The reason these devices are being withdrawn from the market by Instrumed is that Instrumed did not market these devices prior to September 26, 1976, and therefore, does not meet all FDA requirements to market the devices as "Pre-Amendment" devices.
- 2014-12-17FDA-DeviceSnug Seat IncClass IICrocodile (size 3) are two-armed, wheeled walking aids, used by children with disabilities. Product Usage: The Crocodile is a walking aid for children with disabilities, who need supplementary assistance with their daily walking. The Crocodile is available in three sizes and can be used for children between the ages of 2 to 18 years.
The bolts, which secure the handles, on the Crocodile (size 3) could break, causing the handle to dislodge.
- 2014-12-17CPSCGift Craft, of Williamsville, NYWegmans Food Markets Recalls Moody Face Stress Balls Due to Choking Hazard
These rubber stress balls can break into pieces when squeezed, posing a choking hazard to young children.
- 2014-12-10FDA-DeviceAmerx Health Care Corp.Class IIAmerigel Saturated Gauze Dressing Wound management
Formulation deviation
- 2014-12-10FDA-DeviceAmerx Health Care Corp.Class IIAmerigel Daily Dressing Packets Wound management
Formulation deviation
- 2014-12-10FDA-DeviceAmerx Health Care Corp.Class IIAmerigel Post-op Surgical Kits Wound management
Formulation deviation
- 2014-12-10FDA-DeviceAmerx Health Care Corp.Class IIAmerigel Hydrogel Wound Dressing Wound management
Formulation deviation
- 2014-12-10FDA-DeviceCure Medical LLCClass IIPediatric, 10Fr, Intermittent Urinary Catheters Model: P10 Pouch Label UPC (P10) *+M405P100C* Intermediate Box Label UPC (P10) *+M405P103F* Carton Label UPC (P10) *+M405P105H* The product is distributed individually or in intermediate boxes containing 30 individual, sterile packaged catheters (PA/PE film and dialyzing paper pouches). There are 30 catheters packaged in sterile pouches that are placed into an intermediate box, 10 of these intermediate boxes packaged into one case. Int
Some of the intermediate boxes within lot 140417-3, were labeled as P8, a French Size 8 pediatric catheter but actually contain P10, French Size 10 pediatric catheters. Trying to use a P10 catheter for bladder drainage, where P8 catheters have been prescribed, may result in acute urinary retention; and, forced attempts to insert the French Size 10 catheter lead to urethral trauma.
- 2014-12-10FDA-DeviceBeevers Manufacturing & Supply, Inc.Class IICannulaide, Model 101. The Cannulaide product is composed of die-cut hydrocolloid coated polyurethane film with an integral hook strip (i.e., Velcro) to allow for the use of a loop material to help secure a nasal interface. The Cannulaide is applied under and over the nose of infants to provide a protective barrier to the philtrum, columella, septum, nares, and tip of nose. It is available in multiple sizes that vary the external geometry and nare hole size and spacing to allow for use on
Cannulaide model CA 101 was recalled because the firm discovered this model was packed and labeled as CA 102.
- 2014-12-09CPSCDream On Me, of South Plainfield, N.J.Dream On Me Recalls Incredible Play Yards Due to Strangulation Hazard
The play yard's rails can collapse, presenting a strangulation hazards to young children.
- 2014-12-03FDA-DeviceBeevers Manufacturing & Supply, Inc.Class IICannulaide, Model 101, 102, 103. Respirator. The Cannulaide product is composed of die-cut hydrocolloid-coated polyurethane film with an integral hook strip (i.e., Velcro) to allow for the use of a loop material to help secure a nasal interface. The Cannulaide is applied under and over the nose of infants to provide a protective barrier to the philtrum, columella, septum, nares, and tip of nose. It is available in multiple sizes that vary the external geometry and nare hole size and
Cannulaide recalled May 2008 due to improper seal of the pouch. The improper seal of the Cannulaide's package could potentially affect the device shelf life.
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