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.
- 2015-12-29CPSCMacy's Merchandising Group, Inc., of New York, N.Y.Macy's Recalls Martha Stewart Stainless Steel Cookware; Injury Hazard with Frying Pans
The metal discs that cover the frying pan's rivets can pop off and hit consumers, posing an injury hazard.
- 2015-12-23FDA-DeviceElekta, Inc.Class IIMOSAIQ Oncology Information System. Used to manage workflows for treatment planning and delivery.
First Databank (FDB) is a third party product incorporated into MOSAIQ. FDB routinely modifies drugs in their database to reflect market and formulary changes. In FDB Framework v2.0, those drugs are not being included in drug-drug, drug-allergy and duplicate drug therapy interaction checking.
- 2015-12-23FDA-DeviceDraeger Medical, Inc.Class IPerseus A500 Anesthesia Workstation, MK06000. Intended for use in anesthetizing adults, children, and neonates and can be used for automatic and manual ventilation, pressure-supported spontaneous breathing, and spontaneous breathing.
There is a potential problem with the device main power switch of the Perseus A500 Anesthesia Workstation. The device power switch may spontaneously fail during use, causing one of the following to occur: 1. The workstation has a fresh gas delivery failure and a ventilator failure with respective alarms. 2. The workstation shuts down completely with an audible alarm.
- 2015-12-17CPSCAce Bayou Corp., of New Orleans, La.Ace Bayou Reannounces Recall of Bean Bag Chairs Due to Low Rate of Consumer Response; Two Child Deaths Previously Reported; Consumers Urged to Install Repair
The recalled bean bag chairs have two zippers, including an outer zipper that does not have a pull tab and another zipper directly underneath that zipper. Although the outer zipper on the bean bag chair does not have a pull tab, children can open it. Once they have opened the outer zipper, they can open the inner zipper which contains the foam beads and crawl inside. Children can suffocate or choke on these foam beads.
- 2015-12-16FDA-DeviceEdwards Lifesciences, LLCClass IIThin-Flex Venous Cannula, Model Number:TF292902A
Edwards Lifesciences initiated a field action for the Thin-Flex Venous Cannula (Model TF292902A) because the connector size is incorrectly described in the Edwards product guide as 3/8 inch. The actual and correct connector size is 1/2 inch.
- 2015-12-16FDA-DevicePowers Medical Devices, LLCClass IIThe "Pacifier Activated Lullaby" (PAL) System composed of three major components: 1) the PAL Player Module (aka Player Unit), 2) the PAL Pacifier Sensor, and 3) power supply. The system is designed to encourage and reinforce effective non-nutritive sucking of premature infants.
PAL unit has undergone significant technological changes since the previous 510(k) and labeling is not consistent with the cleared indications of the 510(k).
- 2015-12-16CPSCSkip Hop Inc., of New York, N.Y.Skip Hop Recalls Crib Mobiles Due to Injury Hazard
The strap attaching the product to the crib rail can break, posing an injury hazard if the product falls on the infant in the crib.
- 2015-12-10CPSCGreenbrier International, Inc., of Chesapeake, Va.Dollar Tree Recalls Burn Relief Gel Due to Failure to Meet Child Resistant Closure Requirement
The packaging is not child resistant as required by the Poison Prevention Packaging Act. The burn relief gel contains lidocaine, posing a poisoning risk if swallowed.
- 2015-12-09FDA-DevicePhilips Medical Systems, Inc.Class IIPatient Support Material Number: 9890 010 87431, used with:EasyDiagnost ; Model: 706050
The hook does not securely hold the footplate in vertical position. Therefore the footplate can fall or swing down and may hurt the operator or patient.
- 2015-12-09FDA-DevicePhilips Medical Systems, Inc.Class IIPatient Support Material Number: 9890 010 87431 used with: BuckyDiagnost ; Model: 704060/706037
The hook does not securely hold the footplate in vertical position. Therefore the footplate can fall or swing down and may hurt the operator or patient.
- 2015-12-09FDA-DeviceDeRoyal Industries IncClass IIHYDRO-TEMP(R) Neonatal Temperature Skin Sensor, REF HNICU-32, 50 units per box, NON STERILE, Rx only.
DeRoyal manufactured four lots of HNICU-32, Hydro-Temp(R) Neonatal Temperature Skin Sensor incorrectly. The pins contained in the probe were soldered incorrectly. When probe is connected to the proper port, this defect results in the inability to read or display temperatures on the infant warming system.
- 2015-12-09FDA-FoodVRVK Nutraceuticals, LLCClass IDR. VENESSA'S FORMULAS ULTIMATE ANTIOXIDANT TABLETS DIETARY SUPPLEMENT, 120 count bottles, UPC 606851551205
The dietary supplement contains undeclared milk and crustacean shellfish based on FDA's inspection.
- 2015-12-02FDA-DeviceLab Vision CorporationClass IIIThermo Scientific p21 WF1 Ab-3 (DCS-60.2) 1 ml (0.4mg/ml): Product code: MS-230-P and MS-230P0; Hematology: p21WAF1/Cip1/Sdi1/Pic1 is a tumor suppressor protein. Expression of p21WAF1 is induced by wild type, but not mutant, p53 suppressor protein. The p21WAF1 protein binds to cyclin/CDK complexes and inhibits their kinase activity thereby stopping cell cycle progression. It also binds to PCNA (proliferating cell nuclear antigen) and blocks DNA replication but not the DNA repair process.
It was discovered that the labeling of MS-230 antibody incorrectly describes the concentration - label reads 0.2mg/ml but it is actually 0.4 mg/ml.
- 2015-11-25FDA-FoodNational Frozen Foods Corporation--SeattleClass IIItalian Vegetable Blend. Product is frozen, not ready to eat, label carries cooking instruction. Label reads in part Case"***Sysco Imperial ***FIESTA VEGETABLE BLEND***REORDER# ***8446007 *** 6/4 lb*** (UPC) 1 00 74865 52887 7***INGREDIENTS: Broccoli, Carrots, White Beans, Red Kidney Beans, Italian Beans, Garbanzo Beans, Red Peppers***" The inner bags are generic with no UPC code.
Italian Vegetable Blend product is recalled due to potential to be contaminated with Listeria monocytogenes.
- 2015-11-25FDA-FoodNational Frozen Foods Corporation--SeattleClass IIItalian Vegetable Blend. Product is frozen, not ready to eat, label carries cooking instruction. Label reads in part "***Sysco Classic Italian Vegetable Blend***NET WT***2 LB***INGREDIENTS: Zucchini, Carrots, Cauliflower, Italian Green Beans, Baby Lima Beans***UPC 0 74865 01802 9***" Shipping Case UPC Code 10084765018026. Case label reads in part "***Sysco Imperial ITALIAN VEGETABLE BLEND***6/4 lb***INGREDIENTS: Zucchini, Carrots, Cauliflower Florets, Italian Beans, Lima Beans***"
Italian Vegetable Blend product is recalled due to potential to be contaminated with Listeria monocytogenes.
- 2015-11-24CPSCBRP U.S. Inc., of Sturtevant, Wis.BRP Recalls Snowmobiles Due to Fire Hazard (Recall Alert)
Internal damage to the fuel hose can cause a leak, posing a fire hazard.
- 2015-11-24CPSCLutron Electronics Co. Inc., of Coopersburg, Pa.Lutron Electronics Recalls Roman Shades Due to Strangulation Hazard
Strangulations can occur when a child places his/her neck between the exposed ribbon (hobble tape) and the fabric on the backside of the shade or when a child pulls the tape out and wraps it around his/her neck.
- 2015-11-13NHTSA-EquipmentGraco Children's Products, Inc.Graco Children's Products, Inc. — Missing Information on Label/FMVSS 213
An improperly secured child seat may increase the risk of injury in the event of a crash.
- 2015-11-11FDA-DeviceIvoclar A. G.Class IIHelioseal F Sealant Refill 1 x 1.25 g, REF 558519AN, and Helioseal F Assortment (kit) 5 x 1.25 g, REF 558518AN. Dental sealant. -- ivoclar vivadent clinical --- Helioseal F Refill is provided in a syringe packed sealed foil bag. Helioseal F is a light-curing, white-shaded fissure sealant featuring fluoride release. Helioseal fissure sealants are suitable for the sealing of pits, fissures and foramina caeca.
A defect occurred in the production process of Helioseal F Sealant; the particles in the faulty component seem to be larger than the size defined in the formula. This results in difficulties during extrusion of the material.
- 2015-11-11FDA-DeviceHamilton Medical, Inc.Class IHAMILTON-G5 Ventilator with software versions between V2.00 and V2.31. Anesthesiology: The HAMILTON-G5 ventilator is designed for intensive care ventilation of adult and pediatric patients, and optionally infant and neonatal patients
Ventilation and alarms of a HAMILTON-G5 ventilator can be suppressed unintentionally after the activation of a suctioning maneuver by the operator; this situation can occur regardless of the selected patient group (neonatal, pediatric and adult).
- 2015-11-10CPSCBelle Investment Corporation, of Irvine, Calif.Belle Investment Recalls Richie House Boys' Jackets Due to Entanglement Hazard
The jackets have drawstrings in the hood and at the bottom, which pose an entrapment 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.
- 2015-11-10CPSCIgnite USA LLC, of Atlanta, Ga.Ignite Recalls Kids Straw Tumblers Due to Risk of Ingestion
If a child chews on the drinking straw, small pieces can break off into the child's mouth, posing a risk of ingestion or aspiration of the small part.
- 2015-11-03CPSCCarra Imports LLC, of Middleton, Wis.Window Shades Recalled by Carra Imports Due to Strangulation Hazard (Recall Alert)
Cellular, Roller and Soft Horizontal Shades: Strangulation can occur when the shade's continuous loop pull cord or bead chain is not attached to the wall with a tension device and a child's neck becomes entangled in the free-standing loop. Roman Shades: Strangulation can occur when a child places his/her neck between the exposed inner cord and the fabric on the backside of the shade or when a child pulls the cord out and wraps it around his/her neck.
- 2015-11-01USDAClass IDo not eat All American Meats ground beef
Product Contamination
- 2015-10-29CPSCMaeli Rose, of Arcadia, Calif.Maeli Rose Recalls Girls' Hoodies Due to a Strangulation Hazard
The hoodies have a drawstring inside the lining of the hood that surrounds the face 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.
- 2015-10-29CPSCLighthouse Christian Products Co., of Schaumburg, Ill.Lighthouse Recalls Ceramic Mugs Due to Burn Hazard
Hot liquids can seep through hairline cracks, posing a burn hazard.
- 2015-10-28FDA-DeviceCardinal HealthClass IIAmbitex NMD400 Nitrile Exam Gloves size medium. General Hospital and Personal use. Intended to be worn on the hand for medical purposes to provide a barrier against potentially infectious materials and other contaminants.
Ambitex Nitrile NMD400 Exam Gloves size medium on exam hold were inadvertently placed into commerce. The product was under Exam Hold because samples pulled from a shipment manufactured by the firm failed the water leak test performed by FDA as described at 21 CFR 800.20.
- 2015-10-28FDA-DeviceElekta, Inc.Class IIXiO Radiation Treatment Planning System. Used to create treatment plans for any cancer patient for whom external beam radiation therapy or brachytherapy has been prescribed.
Incorrect Treatment Delivery Using Third Party Fixed Wedges.
- 2015-10-28CPSCAmax Enterprises (HK) Limited, of ChinaPottery Barn Kids Recalls Avengers and Darth Vader Water Bottles Due to Violation of Lead Paint Standard
The gray paint on the metal portion of the water bottle can contain excessive levels of lead, violating the federal lead paint standard.
- 2015-10-28CPSCBurley Design LLC, of Eugene, Ore.Burley Design Recalls Child Bicycle Trailers Due to Injury Risk
Trailers with black plastic tow bar receivers can separate from the tow bar when they appear to be connected, posing a crash hazard to the child in the trailer.
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