Baby and kids' product recalls
6737 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.
- 2016-06-22FDA-DeviceNavilyst Medical, Inc., an AngioDyamics CompanyClass IIVaxcel PICC with PASV Catheter Kit under the following labels: 1) 3F, UPN H965454350, Rx ONLY, 2) 4F, UPN M001454550, Rx ONLY & 3) 5F, UPN M001454700, Rx ONLY. The Vaxcel PICC with PASV is indicated for use in establishing peripheral access to the central venous system for administration of fluids including, but not limited to, hydration agents, antibiotics, chemotherapy, analgesics, nutritional therapy, and blood products. It is also indicated for blood specimen withdrawal. This product is int
PICC catheters that contain valve(s) manufactured prior to July 15, 2014 lack a manufacturing specification change that reduces the incidence of hemolysis during blood sampling through the PICC catheter.
- 2016-06-21CPSCThe Land of Nod, of Morton Grove, Ill.The Land of Nod Recalls Octopus Rattles Due to Choking Hazard
The fabric discs on the tentacles of the octopus rattles can detach, posing a choking hazard to young children.
- 2016-06-15FDA-DeviceMedical Components, Inc dba MedCompClass IITearaway Introducer, Model # VS203, VS303, 510 K # 130687, packaged individually in a pouch, 5 pouches per carton, lot # MBZ140, MBZL450, MBZV930 MBZZ490 Product Usage: The 2F and 3F Vascu-Sheath Tearaway Introducer is intended for percutaneous venous access by modified Seldinger Technique in neonates, infants and children.
This recall has been initiated due to the product labeled with the incorrect expiration date.
- 2016-06-15FDA-DeviceHill-Rom, Inc.Class IILiko Universal SlingBars Universal SlingBar" 350, Universal SlingBar" 350 QRH, Universal SlingBar" 350 R2R, Universal SlingBar" 450, Universal SlingBar" 450 QRH, Universal SlingBar" 450 R2R, Universal SlingBar" 600 Universal SlingBar" 600 QRH Component of Liko Lifts Product Usage: Universal SlingBar 350 It is commonly used for lifting children. Universal SlingBar 350 is available with three assembly options - fixed assembly, Quick-release Hook (QRH) or Room 2 Room (R2R
The center bolt of the sling bar, which connects the bar to the patient lift, has failed during use. If the sling bar is not used as intended the bolt may be weakened. If the bolt is weakened there is a potential risk for breakage with the result of a free fall of the patient. This hazard could cause potentially minor to catastrophic injuries to a patient.
- 2016-06-15FDA-FoodCoca-Cola Company (The)Class IIHonest Kids-Super Fruit Punch, Organic Juice Drink, 59 fluid oz. bottle, 006 57622 41273 7, Honest Tea, Inc., 4827 Bethesda Ave., Bethesda, MD 20814.
The label does not list apple juice ingredient present in the beverage.
- 2016-06-14USDAClass IThrow out G & M Co. beef products
Product Contamination
- 2016-06-09CPSCRhino Metals Inc., of Caldwell, IdahoRhino Metals Recalls Handgun Security Safes Due to a Serious Risk of Injury
The handgun security safes can be opened without the use of a combination allowing unauthorized access to a handgun, posing a serious risk of injury to children and others.
- 2016-06-09CPSCZhejiang Haifu Leisure Products Co. Ltd., of ChinaFar East Brokers Recalls Children’s Chairs and Swings Due to Violation of Federal Lead Paint Standard
The screen-printing on the fabric of the chairs and swings contains excessive levels of lead, which is a violation of the federal lead paint standard.
- 2016-06-08FDA-DeviceElekta, Inc.Class IIMonaco RTP System Product Usage: The Monaco system is used to make treatment plans for patients with prescriptions for external beam radiation therapy.
When DICOM exporting a 3D Monaco plan and the "Composite Field Sequencing" (CFS) checkbox is selected, the Y jaws will snap to the port shape when they should remain where they were defined.
- 2016-06-02CPSCHillsdale Furniture, of Louisville, Ky.Hillsdale Furniture Recalls Children's Bunk Beds Due to Fall Hazard; Sold Exclusively at Bob's Discount Furniture (Recall Alert)
The bunk bed's side mattress support rails can crack or break, posing a fall hazard.
- 2016-06-02CPSCLaRose Industries, of Randolph, N.J.LaRose Industries Recalls Cra-Z-Jewelz Ultimate Gem Jewelry Machine Due to Violation of Lead Standard
The "Slider Bracelet" in the jewelry making kit contains high levels of lead. Lead is toxic if ingested by young children and can cause adverse health issues.
- 2016-06-01FDA-DrugLucy's Weight Loss (dba. Waisted With Lucy)Class IShorts on The Beach Strong Formula by Pink Bikini capsules, 750 mg, packaged in 30-count plastic bottle, Manufactured and Distributed by: Lucy's Weight Loss System, Arlington, Texas 76010
Marketed without an approved NDA/ANDA: Product contains undeclared sibutramine and phenolphthalein.
- 2016-06-01FDA-DrugLucy's Weight Loss (dba. Waisted With Lucy)Class IPink Bikini Strong Formula capsules, 750 mg, packaged in 30-count plastic bottle, Manufactured and Distributed by: Lucy's Weight Loss System, Arlington, Texas 76010
Marketed without an approved NDA/ANDA: Product contains undeclared sibutramine and phenolphthalein.
- 2016-05-27CPSCMayborn USA Inc., of Norwood, Mass.Tommee Tippee Sippee Spill-Proof Cups Recalled by Mayborn USA Due to Risk of Mold Exposure
Mold can develop on the removable, one-piece, white valve inside the spill-proof Tommee Tippee Sippee cups when it remains wet/moist and is infrequently cleaned. The CPSC advises that mold ingestion poses a risk of gastrointestinal symptoms and infections in consumers with compromised immune systems.
- 2016-05-26CPSCOsprey Child Safety Products LLC, of Cortez, Colo.Osprey Recalls Child Backpack Carriers Due to Fall Hazard
A cut in the plastic buckle on the shoulder strap can cause the shoulder strap to release, posing a fall hazard to a child in the carrier.
- 2016-05-25FDA-FoodFoodState, IncClass IIMegaFood Multi for Women 40+, Multivitamin & Mineral Dietary Supplement packaged in glass bottles UPC:5149410321 -Packaged 60 tablets; UPC:5149410322 -Packaged 120 tablets
Multi Vitamin label fails to have required warning statement for iron and child resistant cap
- 2016-05-20CPSCBestar Inc., of CanadaBESTAR Recalls Juvenile Dressers Due to Tip-over Hazard (Recall Alert)
The recalled dressers are unstable, posing a serious tip-over and entrapment hazard that can result in death or serious injuries to children.
- 2016-05-19USDAClass IIThrow out Marie Callenders and Molly's Kitchen beef products
Misbranding, Unreported Allergens
- 2016-05-18FDA-DeviceHamilton Medical, Inc.Class IIHamilton G5 with software version between v2.41, v2.42, v2.50. Catalog number: 1590001 and 1590002. Anesthesiology: Hamilton G5 ventilator is designed for intensive care ventilation of adult and pediatric patients, and optionally infants and neonatal patients. The device is intended for use in the hospital and institutional environment where health care professionals provide patient care.
After performing the suctioning maneuver, including disconnecting the patient, suctioning , and reconnecting the patient, the preset pattern of ventilation many not continue as expected.
- 2016-05-18FDA-DeviceCovidien LLCClass IIGiven Imaging Bravo¿¿ pH capsule delivery device, 1-pack. In- Vitor Diagnostic for pH monitoring of gastric reflux Item Number: FGS-0313 The Bravo pH Monitoring System is intended to be used for gastroesophageal pH measurement and monitoring of gastric reflux in adults and children from 4 years of age. The Bravo pH Capsule can be attached following either endoscopy or manometry. The RAPID pH software is intended to record, store, view, and analyze gastroesophageal pH data.
Potential of an allergic reaction in a patient with nickel sensitivity.
- 2016-05-18FDA-DeviceCovidien LLCClass IIGiven Imaging Bravo¿ pH capsule delivery device, 5-pack. In-Vitro Diagnostic for pH monitoring of gastric reflux Item Number: FGS-0312 The Bravo pH Monitoring System is intended to be used for gastroesophageal pH measurement and monitoring of gastric reflux in adults and children from 4 years of age. The Bravo pH Capsule can be attached following either endoscopy or manometry. The RAPID pH software is intended to record, store, view, and analyze gastroesophageal pH data.
Potential of an allergic reaction in a patient with nickel sensitivity.
- 2016-05-18CPSCphil&teds, of Fort Collins, Colo.phil&teds Recalls Dash Strollers Due to Risk of Injury
The hinge used to fold the dash v5 stroller can become damaged while opening and closing the stroller, posing a pinch hazard to the consumer.
- 2016-05-17CPSCPacific Cycle Inc., of Madison, Wis.Pacific Cycle Recalls Infant Bicycle Helmets Due to Choking and Magnet Ingestion Hazards; Sold Exclusively at Target
The magnetic buckle on the helmet's chin strap contains small plastic covers and magnets that can come loose, posing a risk of choking and magnet ingestion to young children.
- 2016-05-12CPSCHobby Lobby Stores Inc., of Oklahoma City, Okla.Hobby Lobby Recalls Infant Rattles Due to Choking Hazard
The rattle seams can separate, exposing the fiber stuffing and bell rattle, posing a choking hazard.
- 2016-05-12CPSCHobby Lobby Stores Inc., of Oklahoma City, Okla.Hobby Lobby Recalls Infant Pacifier Holders Due to Choking Hazard
The fin of the whale and the head of the octopus can detach from the pacifier holder, posing a choking hazard.
- 2016-05-11FDA-DeviceB Braun Medical IncClass IDialog+ Hemodialysis machines: Conductivity Sensor (BIC) Item 3456103A The Dialog+ can be used for implementing and monitoring hemodialysis treatments for patients with acute or chronic kidney failure. The system can be used in hospital, health center and outpatient dialysis center settings when prescribed by a Physician. The following types of renal replacement therapy can be carried out with the system: Hemodialysis (HD) with or without phases of pure ultrafiltration, High flux hemodialysis a
Potential leakage of conductivity sensors of the Dialog Dialysis machines.
- 2016-05-11FDA-DeviceB Braun Medical IncClass IDialog+ Hemodialysis machines: Conductivity Sensor (BIC) Item # 3456102A The Dialog+ can be used for implementing and monitoring hemodialysis treatments for patients with acute or chronic kidney failure. The system can be used in hospital, health center and outpatient dialysis center settings when prescribed by a Physician. The following types of renal replacement therapy can be carried out with the system: Hemodialysis (HD) with or without phases of pure ultrafiltration, High flux hemodialysis
Potential leakage of conductivity sensors of the Dialog Dialysis machines.
- 2016-05-11FDA-DeviceB Braun Medical IncClass IDialog+ Hemodialysis machines: Dialog + 120 V DF+Adimea+WAN-BSL-BIC Product Code # 710200U Serial # 202136 and < 203837 The Dialog+ can be used for implementing and monitoring hemodialysis treatments for patients with acute or chronic kidney failure. The system can be used in hospital, health center and outpatient dialysis center settings when prescribed by a Physician. The following types of renal replacement therapy can be carried out with the system: Hemodialysis (HD) with or without phase
Potential leakage of conductivity sensors of the Dialog Dialysis machines.
- 2016-05-11FDA-DeviceB Braun Medical IncClass IDialog+ Hemodialysis machines: Dialog + 120 V DF+Adimea+WAN-BSL Product Code # 710200S Serial # >200805 and <204001 The Dialog+ can be used for implementing and monitoring hemodialysis treatments for patients with acute or chronic kidney failure. The system can be used in hospital, health center and outpatient dialysis center settings when prescribed by a Physician. The following types of renal replacement therapy can be carried out with the system: Hemodialysis (HD) with or without phases of
Potential leakage of conductivity sensors of the Dialog Dialysis machines.
- 2016-05-11FDA-DeviceB Braun Medical IncClass IDialog+ Hemodialysis machines: Dialog A + 1 Blood Pump 120V Product Code 710200K Serial # >202169 and < 203249 The Dialog+ can be used for implementing and monitoring hemodialysis treatments for patients with acute or chronic kidney failure. The system can be used in hospital, health center and outpatient dialysis center settings when prescribed by a Physician. The following types of renal replacement therapy can be carried out with the system: Hemodialysis (HD) with or without phases of pure
Potential leakage of conductivity sensors of the Dialog Dialysis machines.
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