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.
- 2017-03-15FDA-FoodHormel Foods CorporationClass IIGreat Shake Fortified Nutrition, Soy Formula, Strawberry Artificially Flavored, Packaged in 4 fl oz. (118 mL), and 6 fl oz. (177 mL). Store Frozen.
Hormel Foods is recalling Great Shake and Great Shake Plus, fortified Nutrition drinks, due to presence of undeclared milk.
- 2017-03-15FDA-FoodHormel Foods CorporationClass IIGreat Shake Fortified Nutrition, Soy Formula, Chocolate Artificially Flavored, Packaged in 4 fl oz. (118 mL), and 6 fl oz. (177 mL). Store Frozen.
Hormel Foods is recalling Great Shake and Great Shake Plus, fortified Nutrition drinks, due to presence of undeclared milk.
- 2017-03-14CPSCLCK Design LLC d/b/a Livly Clothing, Sunny Isles, Fla.LIVLY Recalls Children's Sleepwear Due to Violation of Federal Flammability Standard
The children's robes and pajama sets fail to meet federal flammability standards for children's sleepwear, posing a risk of burn injuries to children.
- 2017-03-09CPSCRDG Global LLC, of New YorkRDG Global Recalls Girls’ Hooded Sweatshirts Due to Strangulation Hazard; Sold Exclusively at Nordstrom
The hooded sweatshirts have a drawstring in the hood, 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 or an entanglement hazard to children.
- 2017-03-08FDA-DeviceBecton Dickinson & Co.Class IIBD AffirM VPIII Microbial Identification Test
BD has confirmed that a portion of tests associated with the affected lots( 446252 and 446257 ) of product may exhibit blue speckles or fibers on the beads and cards, as shown below. This issue would result in an invalid test, as described in the package insert.
- 2017-03-08FDA-DeviceOlympus Corporation of the AmericasClass IIUretero-reno videoscope URF-V2 and URF-V2R endoscope and accessories The URF-V2/V2R endoscopes are intended for use in endoscopic diagnosis and treatment within the ureter and kidney.
Olympus has received complaints regarding the breakage of the endoscope's insertion tube bending section during surgical procedures. Some of these complaints are associated with tissue trauma, including perforation, and insertion tubes which were stuck inside the patient and had to be surgically removed.
- 2017-03-02CPSCKids II Inc., of Atlanta, Ga.Kids II Recalls Oball Rattles Due to Choking Hazard
The clear plastic disc on the outside of the ball can break, releasing small beads, posing a choking hazard to young children.
- 2017-03-02USDAClass IThrow out Ohio Farms veal products
Product Contamination
- 2017-03-01FDA-FoodHanover Foods CorporationClass IIWegmans Organic Dark Red Kidney Beans, Net Wt. 15 OZ
Damaged cans could possibly cause a fracture and cause post process contamination.
- 2017-02-28CPSCDillard's Inc., of Little Rock, Ark.Dillard’s Recalls Baby Jackets Due to Choking Hazard
The metal snaps on the jackets can detach, posing a choking hazard to children.
- 2017-02-28CPSCS.R. Smith LLC, of Canby, Ore.S.R. Smith Recalls Helix Pool Slides Due to Fall Hazard
A child can fall off the side of the slide before reaching the pool entry point, posing a fall hazard that can result in serious injury.
- 2017-02-23CPSCLittle Tikes, of Hudson, OhioLittle Tikes Recalls Toddler Swings Due to Fall Hazard
The plastic seat can crack or break, posing a fall hazard.
- 2017-02-22FDA-DrugMS BionicClass IMegaJex Herbal Supplement, Maximum Formula for Men, Fast acting, Increase Stamina, 20 capsules, MS Bionics, Gardena, CA
Marketed without an Approved NDA/ANDA; product contains sildenafil and tadalafil which are active pharmaceutical ingredients in FDA approved drugs used to treat erectile dysfunction (ED)
- 2017-02-22USDAClass IDo not eat Dietz & Watson mortadella slices
Misbranding, Unreported Allergens
- 2017-02-16CPSCBritax Child Safety Inc., of Fort Mill, S.C.Britax Recalls Strollers Due to Fall Hazard
A damaged receiver mount on the stroller can cause the car seat to disengage and fall unexpectedly, posing a fall hazard to infants in the car seat.
- 2017-02-15FDA-DeviceThayer Medical CorporationClass IIThayer MiniSpacer Dual Spray MDI Adapter Counter Incrementing Actuator with 15mm O.D./I.D. Connections, Reference no. 1543A. The 15 mm Dual Spray MiniSpacer with Counter Incrementing Actuator is a non-sterile, single-use item, intended to dispense aerosolized medication into a breathing circuit or ancillary circuits. MINISPACER adapters are indicated for patients on a breathing circuit, for whom aerosol medication has been prescribed, in short and long term critical care environments. The 15 mm
The insert and case label description of the device incorrectly reads Counter Incrementing Actuator with 22mm O.D./I.D. Connections.
- 2017-02-15USDAClass IIICheck chicken sausage packages for MSG labeling
Misbranding
- 2017-02-10CPSCRestoration Hardware Inc., of Corte Madera, Calif.Restoration Hardware Recalls Metal Top Dining Tables Due to Risk of Lead Exposure
The table's metal top can contain lead and presents a risk of lead exposure to children. Lead is toxic if ingested and can cause adverse health effects.
- 2017-02-09CPSCFeld Entertainment Inc., of Vienna, Va.Feld Entertainment Recalls Toy Wands Due to Injury Hazard; Sold Exclusively at Disney On Ice and Disney Live Shows
The top component can detach and expose an 8-inch metal rod, posing an injury hazard to young children.
- 2017-02-01FDA-DeviceBaxter Healthcare CorporationClass IIMaintenance Kit PH2, Cod. 6997274 The Phoenix Hemodialysis delivery system is intended to be used to provide high flux and low flux hemodialysis, hemofiltration and ultrafiltration on patients weighing 15 Kilograms or more. The Phoenix system is to be used with either high or low permeability dialyzers. The device is intended to be used by trained operators when prescribed by a physician, in a chronic care dialysis facility or acute care unit
Baxter Healthcare Corporation is issuing a voluntary product recall for several lots of Phoenix Dialysis Machine Preventive Maintenance Kits due to incorrect silicone straight connectors components packaged in these kits. During Preventive Maintenance, the two silicone connectors must be installed in the Phoenix mass-balance section of hydraulic circuit only if the Phoenix machine has already been modified with "CONN. IMPROVING RETR. KIT" (Code SP00721). Installation of these connectors in machines modified with SP00721 may result in fluid leaks during dialysis treatment. These Preventive Maintenance Kits include the FILTER sub-group, which contains the silicone straight connectors that are larger than expected.
- 2017-02-01FDA-DeviceBaxter Healthcare CorporationClass IIMaintenance Kit PH1, Cod. 6997266 The Phoenix Hemodialysis delivery system is intended to be used to provide high flux and low flux hemodialysis, hemofiltration and ultrafiltration on patients weighing 15 Kilograms or more. The Phoenix system is to be used with either high or low permeability dialyzers. The device is intended to be used by trained operators when prescribed by a physician, in a chronic care dialysis facility or acute care unit
Baxter Healthcare Corporation is issuing a voluntary product recall for several lots of Phoenix Dialysis Machine Preventive Maintenance Kits due to incorrect silicone straight connectors components packaged in these kits. During Preventive Maintenance, the two silicone connectors must be installed in the Phoenix mass-balance section of hydraulic circuit only if the Phoenix machine has already been modified with "CONN. IMPROVING RETR. KIT" (Code SP00721). Installation of these connectors in machines modified with SP00721 may result in fluid leaks during dialysis treatment. These Preventive Maintenance Kits include the FILTER sub-group, which contains the silicone straight connectors that are larger than expected.
- 2017-02-01FDA-DeviceAtrium Medical CorporationClass IIAtrium Medical Oasis Pediatric Drain as follows: 3612-100 Oasis Infant/Pediatric drain with in-line connector, ¿ in. tubing, Sims and Pedi connector in bag on back of drain 3612-400 Oasis Infant/Pediatric drain with no in-line connector, ¿ in. tubing, Sims and Pedi connector in bag on back of drain Product Usage: To evacuate air and/or fluid from the chest cavity or mediastinum. To help re-establish lung expansion and restore breathing dynamics. To facilitate postoperative collection
Outer Packaging is not sterile
- 2017-02-01FDA-DeviceAtrium Medical CorporationClass IIAtrium Medical Pediatric Chamber Ocean Drains as follows: 2012-320 Ocean Infant/Pediatric drain, with in-line connector and suction control stopcock, ¿ in. Tubing, Sims and Pedi connector in bag on back of drain Product Usage: To evacuate air and/or fluid from the chest cavity or mediastinum. To help re-establish lung expansion and restore breathing dynamics. To facilitate postoperative collection and reinfusion of autologous blood from the patient s pleural cavity or mediastinal area.
Outer Packaging is not sterile
- 2017-01-31CPSCSouth Shore Industries Ltd., of CanadaSouth Shore Recalls Chests of Drawers Due to Serious Tip-Over and Entrapment Hazards (Recall Alert)
The recalled chests are unstable if they are not anchored to the wall, posing a serious tip-over and entrapment hazard that can result in death or injuries to children. The chests do not comply with the performance requirements of the U.S. voluntary industry standard (ASTM F2057-14).
- 2017-01-31CPSCSimpli Home Ltd., of Olympia, Wash.Simpli Home Recalls Chests of Drawers Due to Serious Tip-Over Hazard (Recall Alert)
The recalled chests are unstable if they are not anchored to the wall, posing a serious tip-over and entrapment hazard that can result in death or injuries to children. The chests do not comply with the performance requirements of the U.S. voluntary industry standard (ASTM F2057-14).
- 2017-01-31CPSCBolton Furniture, of Morrisville, Vt.Bolton Furniture Recalls Dressers Due to Serious Tip-Over and Entrapment Hazards
The recalled dressers are unstable if they are not anchored to the wall, posing a serious tip-over and entrapment hazard that can result in death or injuries to children. The dressers do not comply with the performance requirements of the U.S. voluntary industry standard (ASTM F2057-14).
- 2017-01-24CPSCPulse Performance Products, a division of Bravo Sports, of Santa Fe Springs, Calif.Pulse Performance Recalls Children's Electric Scooters Due to Fall Hazard; Sold Exclusively at Target
The knuckle that joins the wheel to the axle can break, posing a fall hazard to the rider.
- 2017-01-18FDA-DeviceGE Healthcare, LLCClass IIInfant Warmer System (IWS)
GE Healthcare has recently become aware of a potential safety issue related to loose screws in the Heater Head of the Infant Warmer System (IWS). Hot screws from the Heater Head of the IWS could fall onto the bed if the Heater Head assembly has been improperly serviced. This situation can be clinically hazardous because thermal injury to a patient could result. Two injuries have been reported as a result of this issue.
- 2017-01-18FDA-DeviceBard Access SystemsClass IISafeStep¿ Huber Needle Set with Y-Injection Site. Product Code: LH-0029YN. Packaged as single units in thermoformed trays. There are 25 SafeStep¿ trays per case and 100 per carton. Product Usage: Intended for the administration of fluids and drugs, or blood sampling through surgically implanted vascular ports.
Bard Access Systems announces a voluntary field action for the SafeStep¿ Huber Needle Set with Y-Injection Site and MiniLoc¿ Safety Infusion Set Winged without Y-Injection Site devices because sets may contain one or more units where the needle length and gage differs from the length and gage described on the label.
- 2017-01-18FDA-DeviceBard Access SystemsClass IIMiniLoc¿ Safety Infusion Set Winged without Y-Injection Site. Product Code: S02022-75. Packaged as single units in thermoformed trays. There are 20 MiniLoc¿ trays per case and 160 per carton. Product Usage: Intended for the administration of fluids and drugs, or blood sampling through surgically implanted vascular ports.
Bard Access Systems announces a voluntary field action for the SafeStep¿ Huber Needle Set with Y-Injection Site and MiniLoc¿ Safety Infusion Set Winged without Y-Injection Site devices because sets may contain one or more units where the needle length and gage differs from the length and gage described on the label.
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