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.
- 2018-03-14FDA-DeviceMedtronic NeuromodulationClass IIMedtronic Synchromed II Model 8637 supplied in 20mL and 40 mL reservoir size and a catheter. Product Usage: The implantable Model 8637 SynchroMed II programmable pump is part of an infusion system that stores and delivers a prescribed drug to a specific site. The implanted infusion system consists of a Model 8637 SynchroMed II pump, supplied in 20 ml and 40 ml reservoir sizes, and a catheter. In the United States, the SynchroMed II Pump is specifically approved (indicated) for drugs as refer
Medtronic implemented a final design change intended to address the motor stall due to corrosion and is recalling devices with the previous design that are not implanted.
- 2018-03-14FDA-DeviceMindray DS USA, Inc. dba Mindray North AmericaClass IIA-Series A7 Anesthesia Delivery System; Model Number: 0632F-PA0000X (A7) Product Usage: The A-Series Anesthesia System is a device used to administer to a patient, continuously or intermittently, a general inhalation anesthetic, and to maintain a patient s ventilation. The A-Series is intended for use by licensed clinicians, for patients requiring anesthesia within a health care facility, and can be used for adult, pediatric, and infant populations.
A software issue may result in the previous settings being applied instead of the default settings or the unit may skip the startup leak test.
- 2018-03-14FDA-DeviceMindray DS USA, Inc. dba Mindray North AmericaClass IIA-Series A3/A5 Anesthesia Delivery System; Model Numbers: 0633F-01000-0X (A3) and 0631F-01000-0X (A5) Product Usage: The A-Series Anesthesia System is a device used to administer to a patient, continuously or intermittently, a general inhalation anesthetic, and to maintain a patient s ventilation. The A-Series is intended for use by licensed clinicians, for patients requiring anesthesia within a health care facility, and can be used for adult, pediatric, and infant populations.
A software issue may result in the previous settings being applied instead of the default settings or the unit may skip the startup leak test.
- 2018-03-14FDA-DrugBayer HealthCare Pharmaceuticals, Inc.Class IICoppertone Kids Sunscreen Spray (avobenzone 3%, Homosalate 10%, Octisalate 5%, Octocrylene 4%, Oxybenzone 5%) 8.3 oz. bottle, Dist. by: Bayer Healthcare LLC Whippany, NJ 07981, UPC 41100573636.
Labeling: Label mix-up
- 2018-03-14CPSCJinhua Longyou Import and Export Co., of ChinaCameron Company Recalls Children's Tents Due to Laceration Hazard; Sold Exclusively at Home Depot
The fiberglass rod that supports the tent can break, splinter and become sharp, posing a laceration hazard to consumers.
- 2018-03-14CPSCRadio Flyer Inc., of Chicago, Ill.Radio Flyer Recalls Electric Wagons Due to Injury Hazard
Improper wiring can activate the wagon's motor unintentionally, posing an injury hazard.
- 2018-03-07FDA-DeviceFresenius Medical Care Renal Therapies Group, LLCClass II2008T, Hemodialysis Delivery System Product Indicated for acute and chronic dialysis therapy.
While reviewing documentation for the next software release of the 2008T, an R&D technician identified that setting the UF goal to '0' introduces a discrepancy between the UF rate displayed and the actual UF pump rate. The software anomaly is also applicable to the 2008T Machines that contained the 2.63 Bug Fix per DCAF 17-088. 2008T Upgrade kits that contained the 2.63 Bug Fix are also affected. Additionally, SW version 2.64 (in design freeze) is also impacted by this anomaly.
- 2018-03-07FDA-DeviceZOLL Medical CorporationClass II731 Series Ventilators running software version 05.20.00 The devices in the ZOLL ventilator are indicated for use in the management of infant through adult patients weighing ;:: 5 kg with acute or chronic respiratory failure or during resuscitation by providing continuous positive-pressure ventilation. They are appropriate for use in hospitals, outside the hospital, during transport and in severe environments where they may be exposed to rain, dust, rough handling, and extremes in temperatur
A software anomaly in the 731 software version 05/20/00, was identified, which can lead to a user inadvertently changing device settings.
- 2018-03-07FDA-DeviceCooperVision Inc.Class IIIBiofinity XR Toric contact lenses 8.7/14.5 - 6PK Biofinity XR Toric (comfilcon A) Soft (Hydrophilic) Contact Lenses are indicated for the correction of ametropia (myopia or hyperopia) with astigmatism) in aphakic and non-aphakic persons with non-diseased eyes in powers from -20.00 to +20.00 diopters and astigmatic corrections from -0.25 to -5.75 diopters. The Biofinity (comfilcon A) Soft (Hydrophilic) Contact Lenses have been approved for extended wear for up to 6 nights /7 days of continuo
The firm identified a labeling error affecting Made-To-Order (MTO) Biofinity XR Toric blister labels. The primary blister reads Biofinity Multifocal Toric in error, and should read Biofinity XR Toric. The outer carton correctly reads Biofinity XR Toric.
- 2018-03-07CPSCUnited Exchange Corporation, of Cerritos, Calif.First Aid Research Recalls Maximum Strength Bacitraycin Plus Ointment With Lidocaine Due to Failure to Meet Child Resistant Closure Requirement
The packaging is not child resistant as required by the Poison Prevention Packaging Act. The pain relieving ointment contains lidocaine, posing a risk of poisoning to young children if they put it on their skin or ingest it.
- 2018-03-01CPSCWonderland Nursery Goods Co., LTD, of Dongguan Guangdong, ChinaGraco Recalls Highchairs Due to Fall Hazard; Sold Exclusively at Walmart
The highchair's rear legs can pivot out of position making the chair unstable and posing a fall hazard to a child in the highchair.
- 2018-02-28CPSCLemur Group Inc., owner of the PL Sleep and Petit Lem brands, of CanadaPL Sleep Children's Sleepwear Recalled by Lemur Group Due to Violation of Federal Flammability Standard
The children's nightgowns fail to meet the flammability standards for children's sleepwear, posing a risk of burn injuries to children.
- 2018-02-21FDA-DeviceCincinnati Sub-Zero Products LLCClass IIHemotherm¿ Dual Reservoir Cooler/Heater System Models 400CE and 400MR Product Usage: A dual reservoir, water re-circulating device that supplies temperature controlled water to a heat exchanger. The device, in conjunction with a heat exchanger, is used to warm or cool the blood that enters and exits a blood heat exchanger for adult, pediatric or infant patients.
Due to FDA's safety communication relating to nontuberculous mycobacteria (NTM) infections related to heater/cooler devices, an updated Instructions For Use includes a more robust cleaning & disinfection procedure.
- 2018-02-21FDA-DeviceAMEDA, INC.Class IIIPurely Yours Breast Pump. Model 17070PMW and Model 17070ACA. Intended to express and collect the mother s milk from the breasts of a nursing woman for the purpose of feeding the collected milk to a baby.
Two specific lots was incorrectly manufactured containing a UK power adapter.
- 2018-02-21FDA-DeviceBeckman Coulter Inc.Class IILyophilized Chemistry Calibrator Level 1 Product Usage: Beckman Coulter Chemistry Calibrators are intended for use when calibrating methods run on the Beckman Coulter AU series of chemistry analyzers. Beckman Coulter Chemistry Calibrators are lyophilized, human serum based products formulated for use as a reference material when calibrating Beckman Coulter AU clinical chemistry system assays. The calibrators are used to calibrate the following assays: Albumin (ALB), Bicarbonate (CO2), Direc
Unpaired lots of AU lyophilized chemistry calibrator level 1 and 2 have been distributed. Calibrator level 1 and 2 must be paired when used for calibration and cannot be used in any other combination. If lot numbers are not correctly paired, calibration can be run using incorrect set points which may generate erroneous results. QC failures could occur if incorrect pairs of calibrators are used.
- 2018-02-20CPSCNEMO Equipment of Dover, N.H.NEMO Equipment Recalls Stargaze Recliner Chairs Due to Fall Hazard; Sold Exclusively at REI
The straps on the chair seats can fail, posing a fall hazard.
- 2018-02-14USDAPublic Health AlertThrow out Fareway Chicken Salad
Product Contamination
- 2018-02-13CPSCTea Living Inc, San Francisco, Calif. (d/b/a Tea Collection)Tea Collection Recalls Children's Rompers Due to Choking Hazard
The snaps near the collar can detach, posing a choking hazard to young children.
- 2018-02-07FDA-FoodJarrow Formulas IncClass IIJarrow Formulas Liquid L-Carnitine; 16 fl oz. (475 ml) bottle, dietary supplement; product number 102006; UPC 7 90011 02006 6; Vitamin B5 10 mg; L-Carnitine 1000 mg; Other ingredients: Purified water, xylitol, glycerin, citric acid, natural lemon-lime flavor, nisin (as a preservative). Distributed exclusively by Jarrow Formulas Los Angeles, CA.
A higher than normal micro result was found at the six month time point for one lot of Liquid L-Carnitine.
- 2018-02-01CPSCHunter Douglas Window Fashions Inc., of Broomfield, Colo.Hunter Douglas Recalls Privacy Sheer Blinds Due to Strangulation Hazard (Recall Alert)
The cord restraints on the combination wand/cord of the sheer blinds can break, posing a strangulation hazard to children.
- 2018-02-01CPSCGildan Activewear SLR, dba Alstyle, of BarbadosInfant Bodysuits Recalled Due to Choking Hazard; Made by Alstyle
The snaps at the crotch can detach, posing a choking hazard to young children.
- 2018-01-31FDA-DeviceVyaire MedicalClass IInfant AirLife Dual-,limb, dual-heat, high-flow circuit (Model AH265) with AirLife Humidification Chamber, Model Number AH290. The AH290 Humidification Chamber and Heated Breathing Circuit Kit(s) operate as part of a system for delivering health and humidified respirator gasses to patients requiring invasive and non-invasive ventilation.
Manufacturing error in humidification chamber may cause an overfill/overflow condition of the chamber. The may case a water back-up into the patient circuit resulting in an excessive amount of water entering the airway/lungs of the ventilated patient.
- 2018-01-31FDA-DeviceVyaire MedicalClass IInfant AirLife single-limb, continuous-flow circuit (Model AH132) containing AirLife Humidification Chamber, Model Number AH290. The AH290 Humidification Chamber and Heated Breathing Circuit Kit(s) operate as part of a system for delivering health and humidified respirator gasses to patients requiring invasive and non-invasive ventilation.
Manufacturing error in humidification chamber may cause an overfill/overflow condition of the chamber. The may case a water back-up into the patient circuit resulting in an excessive amount of water entering the airway/lungs of the ventilated patient.
- 2018-01-31FDA-FoodPharmatech LLCClass IILeader Liquid Multivitamin Supplement for Infants and Toddlers 50 mL UPC 096295128611
Presence of yeast and potential contamination with B. cepacia.
- 2018-01-31FDA-FoodPharmatech LLCClass IILeader Liquid Vitamin D Supplement for Breastfed Infants 400 IU 50 mL UPC 096295128628
Presence of yeast and potential contamination with B. cepacia.
- 2018-01-31FDA-DrugBotanicalNowClass IBodySlim Herbal Advanced technology & Strong formula capsules, 400 mg, 30-count bottle, Barcode: 9567153432481
Marketed without an approved NDA/ANDA: FDA analysis found the product to contain undeclared sibutramine.
- 2018-01-31CPSCVornado Air LLC, of Andover, Kan.Vornado Air Recalls Cribside Space Heaters Due to Fire and Burn Hazards
A broken motor mount can allow the electric heating element to come in contact with the interior plastic materials and ignite, posing fire and burn hazards.
- 2018-01-30CPSCNatureplex LLC, of Olive Branch, Mass.Walgreens Pain and Itch Relief Cream Recalled by Natureplex Due to Failure to Meet Child Resistant Closure Requirement
The packaging is not child resistant as required by the Poison Prevention Packaging Act. The pain and itch relief cream contains lidocaine, posing a risk of poisoning to young children.
- 2018-01-25CPSCImpekk Montreal, of CanadaRockler Recalls Murphy Bed Kits Due to Tip-Over and Entrapment Hazards (Recall Alert)
The hardware kits used to secure the wooden wall enclosures to the wall studs do not provide sufficient bracing support, posing serious tip-over and entrapment hazards that can result in death or injuries to children.
- 2018-01-25CPSCVTech Electronics Ltd, of ChinaVTech Recalls Lights & Lullabies Travel Mobiles Due to Injury Hazard
The clamp attaching the mobile to the crib rail can break causing the mobile to fall, posing an injury hazard to an infant in the crib.
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