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.
- 2018-08-29FDA-DevicePhilips Medical Systems Gmbh, DMCClass IIBuckyDiagnost Ceiling System (Stitching Patient Support) 704031
The hook does not securely hold the footplate in the vertical position. Therefore, the footplate can fall or swing down and injury operator or patient.
- 2018-08-29FDA-DevicePhilips Medical Systems Gmbh, DMCClass IIDigitalDiagnost Release 3.1 (Stitching Patient Support) 712026
The hook does not securely hold the footplate in the vertical position. Therefore, the footplate can fall or swing down and injury operator or patient.
- 2018-08-29FDA-DevicePhilips Medical Systems Gmbh, DMCClass IIDigitalDiagnost Release 3 (Stitching Patient Support) 712025
The hook does not securely hold the footplate in the vertical position. Therefore, the footplate can fall or swing down and injury operator or patient.
- 2018-08-29FDA-DevicePhilips Medical Systems Gmbh, DMCClass IIDigitalDiagnost 4.1 High Performance (Stitching Patient Support) 712031
The hook does not securely hold the footplate in the vertical position. Therefore, the footplate can fall or swing down and injury operator or patient.
- 2018-08-29FDA-DevicePhilips Medical Systems Gmbh, DMCClass IIDigitalDiagnost 4 Flex / Value (Stitching Patient Support) 712028
The hook does not securely hold the footplate in the vertical position. Therefore, the footplate can fall or swing down and injury operator or patient.
- 2018-08-29FDA-DevicePhilips Medical Systems Gmbh, DMCClass IIDigitalDiagnost 2.x Upgrades (Stitching Patient Support) 712082
The hook does not securely hold the footplate in the vertical position. Therefore, the footplate can fall or swing down and injury operator or patient.
- 2018-08-29FDA-DeviceLIEBEL-FLARSHEIM COMPANY LLCClass IILiebel-Flarsheim Direct Digital Imaging System (DDIS) Liebel-Flarsheim urology systems facilitate radiologic and/or fluoroscopic procedures requiring a beam of diagnostic quality radiation, primarily for urological applications such as functional x-ray diagnostics, endourology and minimal invasive urology/ surgery.
Software issue. The difference between the display and dosimeter readings In the Child/Pediatric automatic exposure mode is in the range of 52-65%. The display in all other modes deviated by less than 35% from the dosimeter readings.
- 2018-08-29FDA-DeviceLIEBEL-FLARSHEIM COMPANY LLCClass IILiebel-Flarsheim Hydra Vision Urology X-Ray System (DR) Liebel-Flarsheim urology systems facilitate radiologic and/or fluoroscopic procedures requiring a beam of diagnostic quality radiation, primarily for urological applications such as functional x-ray diagnostics, endourology and minimal invasive urology/ surgery.
Software issue. The difference between the display and dosimeter readings In the Child/Pediatric automatic exposure mode is in the range of 52-65%. The display in all other modes deviated by less than 35% from the dosimeter readings.
- 2018-08-29FDA-DrugPreferred Pharmaceuticals, IncClass IIValsartan Tablets USP 320 mg, 90-count, plastic child resistant bottle, Rx Only, Preferred Pharmaceuticals, Inc., 1250 N. Lakeview Ave., Suite O, Anaheim, CA 92807, NDC 68788-6882-9
CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.
- 2018-08-29CPSCBSN SPORTS LLC, of Farmers Branch, TexasBSN SPORTS Recalls Rubber Critter Toys Due to Violation of Federal Lead Paint Ban (Recall Alert)
The orange and yellow surface paint on the rubber critter toys contains levels of lead that exceed the federal lead paint ban. Lead is toxic if ingested by young children and can cause adverse health issues.
- 2018-08-24USDAPublic Health AlertDo not eat Empire Kosher raw chicken
Product Contamination
- 2018-08-23CPSCThe Manhattan Toy Company LLC, of Minneapolis, Minn.Manhattan Toy Recalls Toy Planes Due to Choking Hazard
The rubber tires can separate from the wheels, posing a choking hazard for young children.
- 2018-08-22FDA-DeviceHamilton Medical AGClass IIHamilton-C3 Ventilator Unit Product Usage: The HAMILTON-C3 ventilator is intended to provide positive pressure ventilator support to adults, pediatrics, infants and neonates depending on its configuration. The device is used in the intensive care ward, intermediate care ward, emergency ward, long term acute care hospital or in the recovery room, and during transfer of ventilated patients within the hospital.
An out of specification component on the control board may cause the ventilator to open the inspiratory channel and the expiratory valve. The ventilator will shut down and an emergency buzzer providing an acoustic alarm and the blinking alarm LED on the device s front side.
- 2018-08-22FDA-DeviceClarity Diagnostics LlcClass IIIClarity Urocheck 10SG Urinalysis Strips, Model # DTG-10SG Product Usage: Clarity 10SG Urinalysis Reagent Strips (Urine) are for the qualitative and semi-quantitative detection of the following analytes in urine: Glucose, Bilirubin, Ketone (Acetoacetic acid), Specific Gravity, Blood, pH, Protein, Urobilinogen, Nitrite and Leukocytes. The Clarity Urinalysis Reagent Strips (Urine) are for single use in professional near-patient (point-of-care) and centralized laboratory locations, and are inten
Clarity Diagnostics LLC discovered specific lots of Clarity 10SG Strips are not compatible for use in the Clarity Urocheck 120 Urine Analyzers, due to lack of Canister Code Bar Code Label.
- 2018-08-21CPSCConfer Plastics, of North Tonawanda, N.Y.Confer Plastics Recalls Pool Step Systems Due to Entrapment and Drowning Hazard
Children's limbs can become entrapped in the side openings of the step systems, posing a drowning hazard.
- 2018-08-15FDA-DeviceVyaire MedicalClass IAirLife Resuscitation Device, Pediatric labeled as the following: a. Pediatric, with mask, 28" large bore tubing, pressure-relief valve, Part Number 2K8018; b. Pediatric, with mask, 40" oxygen reservoir bag, pressure-relief valve, Part Number 2K8008; c. Pediatric, Resuscitation kit with neonatal, infant and pediatric masks, Part Number RE1DK5445D; d. Pediatric, with mask, oxygen reservoir bag, pressure-relief valve, PEEP valve, Part Number 2K8039 Manual resuscitation devi
An error in manufacturing of the AirLife Resuscitation Devices that has the potential to obstruct airflow of the supplemental oxygen delivery during use.
- 2018-08-15FDA-FoodThe Pictsweet CompanyClass IPictsweet Farms Steam'ables Baby Brussels Sprouts***NET WT 12 OZ (340g)***THIS SIDE UP IN MICROWAVE***Nutrition Facts***INGREDIENTS: BRUSSEL SPROUTS***
Undeclared allergens on the labeling.
- 2018-08-15NHTSA-EquipmentHickory Springs Manufacturing CompanyHickory Springs Manufacturing Company — Warning Label Missing From Lower Strap/FMVSS 213
Without a warning label, the seat may be used improperly, increasing the risk of injury.
- 2018-08-09CPSCHarbor Freight Tools, of Calabasas, Calif.Harbor Freight Tools Recalls Handgun Safes Due to Serious Injury Hazard
The handgun safes can open without the use of a key or combination upon impact and allow unintended access to the contents of the safe, posing a risk of serious injury to children and others.
- 2018-08-08FDA-DeviceZimmer Surgical IncClass IIZimmer Dermatone AN, Model No. 88710100
Devices may have a loose control bar, which could compromise the ability to control the thickness of the graft. Devices could also have a loose width plate that if undetected, could result in an imperfect, yet still usable graft. Potential risks include harvesting a skin graft of a thickness much greater than intended, described as patient gouged, minor delay of surgery, and sub-optimal (but usable) graft.
- 2018-08-08FDA-FoodAPOGEE FOODSClass IIThunderbird Bars 1.15 oz Apple Pie Kid Bar (carton of 120)
The process control points did not reach the set temperature requirements.
- 2018-08-07CPSCNEMO Equipment of Dover, N.H.NEMO Equipment Recalls Stargaze Recliner Chairs Due to Fall Hazard
The plastic joint supports attached to the legs of the chairs can break, posing a fall hazard.
- 2018-08-01FDA-DeviceForte Automation Systems IncClass IIPatient Positioning System with KRC2 controller using software versions 2.3.1 2.3.10 Product Usage: The patient positioning system is a SCARA designed robotic arm designed to position a patient for medical procedures prescribed by oncologists and others that require a high degree of accuracy and repeatability.
Communications between the Patient Positioning System and the accuracy filter can periodically fail with no clear indication to the operator.
- 2018-08-01FDA-FoodAMPIClass IIAMPI Whey Powder, Sweet Type, Formula 521, Extra Grade, spray process pasteurized, packaged in 50 lbs net (22.68 kg net) and 25 kg net (55.12 lbs net).
Whey powder may have the potential to be contaminated with Salmonella.
- 2018-07-31CPSCJohnson Health Tech North America, Inc. of Cottage Grove, Wis.Additional Incidents Prompt Johnson Health Tech to Reannounce Recall of Matrix Fitness Ascent Trainers and Ellipticals Due to Fire Hazard (Recall Alert)
Moisture from user perspiration or cleaning liquids can build up in the power socket on the unit, causing a short circuit, posing a fire hazard.
- 2018-07-26CPSCJimmy Hack Golf LLC, of Easley, S.C.Jimmy Hack Golf Recalls Golf Swing Trainers Due to Injury Hazard
The orange ball can detach from the trainer while in use, posing an injury hazard to the user and bystanders.
- 2018-07-25FDA-DeviceCardinal Health 200, LLCClass IIPresource PBDS, Kit, No Spiro Diabetes. Kit includes a exerciser volumetric 5000 ML device, two items of cloth, skin prep 2% CHG, a packet of 4 chlorhexidine gluconate antiseptic cloths, and Gatorade pouches. Product Usage: The kit is provided to a patient pre-surgery, as part of the Enhanced Recovery After Surgery protocol. Items included at 1) an exerciser volumetric 5000ML device that is utilized to foster improved lung performance in an effort to avoid potential pulmonary post-opera
A defect in the seal of the Gatorade pouch contained in kits caused the pouch to leak within a limited portion of the kit.
- 2018-07-25FDA-DeviceCardinal Health 200, LLCClass IIPresource PBDS, Kit, No Spiro. Kit includes a exerciser volumetric 5000 ML device, two items of cloth, skin prep 2% CHG, a packet of 4 chlorhexidine gluconate antiseptic cloths, and Gatorade pouches. Product Usage: The kit is provided to a patient pre-surgery, as part of the Enhanced Recovery After Surgery protocol. Items included at 1) an exerciser volumetric 5000ML device that is utilized to foster improved lung performance in an effort to avoid potential pulmonary post-operative comp
A defect in the seal of the Gatorade pouch contained in kits caused the pouch to leak within a limited portion of the kit.
- 2018-07-25FDA-DeviceCardinal Health 200, LLCClass IIPresource PBDS, Kit, Common. Kit includes a exerciser volumetric 5000 ML device, two items of cloth, skin prep 2% CHG, a packet of 4 chlorhexidine gluconate antiseptic cloths, and Gatorade pouches. Product Usage: The kit is provided to a patient pre-surgery, as part of the Enhanced Recovery After Surgery protocol. Items included at 1) an exerciser volumetric 5000ML device that is utilized to foster improved lung performance in an effort to avoid potential pulmonary post-operative compli
A defect in the seal of the Gatorade pouch contained in kits caused the pouch to leak within a limited portion of the kit.
- 2018-07-25FDA-DeviceCardinal Health 200, LLCClass IIPresource PBDS, Kit, Common Diabetes. Kit includes a exerciser volumetric 5000 ML device, two items of cloth, skin prep 2% CHG, a packet of 4 chlorhexidine gluconate antiseptic cloths, and Gatorade pouches. Product Usage: The kit is provided to a patient pre-surgery, as part of the Enhanced Recovery After Surgery protocol. Items included at 1) an exerciser volumetric 5000ML device that is utilized to foster improved lung performance in an effort to avoid potential pulmonary post-operati
A defect in the seal of the Gatorade pouch contained in kits caused the pouch to leak within a limited portion of the kit.
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