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.
- 2018-10-24FDA-DrugProduct Quest Manufacturing LLCClass IICVS Health, Baby Nasal Spray/Drops, Non-Medicated, 0.5 FL OZ (15 mL) bottle, Distributed by: CVS Pharmacy, Inc., One CVS Drive, Woonsocket, RI 02895, UPC 0 50428 29380 5 Product #459367.
CGMP Deviations: products manufactured under conditions that could impact its product quality.
- 2018-10-24FDA-DrugProduct Quest Manufacturing LLCClass IICVS Health, Sterile Saline Nasal Mist (sodium chloride) Saline Nasal Moisturizer, 0.9%, packaged in a) Net Wt. 1.52 OZ (43 g) can UPC 0 50428 37079 7 Product #896831; b) Net Wt. 4.25 OZ (120 g) can UPC 0 50428 36124 5; c) Children's Net Wt. 2 OZ (57 g) can UPC 0 50428 58685 3 Product #282472, Distributed by: CVS Pharmacy, Inc., One CVS Drive, Woonsocket, RI 02895.
CGMP Deviations: products manufactured under conditions that could impact its product quality.
- 2018-10-19USDAClass IThrow out Jenny Craig chicken wraps
Product Contamination
- 2018-10-19USDAClass IDon't eat Envolve Foods chicken and beef products
Product Contamination
- 2018-10-17FDA-DeviceWidex A/SClass IIWidex BABY hearing aid (referred to as BABY440), powered by zinc-air batteries size 10 Intended use: BABY440 is intended for, but not limited to, babies (0 to 3 years of age) to be used as air conduction amplification devices in everyday listening environments.
The reason for this field action is due to the mounting of a non-tamper-resistant (ordinary) battery drawer on some BABY440 hearing aids. The correct battery drawer is tamper-resistant and require a special tool to open it.
- 2018-10-16CPSCAbond Group, of CanadaAbond Group Recalls Tubeez Baby Bath Support Seats Due to Drowning Hazard
The bath support seat fails to meet the federal safety standard including the requirements for stability. The bath seat can tip over or an infant can slip underneath the front support, posing a drowning hazard.
- 2018-10-16CPSCWoodfield Baby Products, Guangdong, ChinaGold Recalls Eddie Bauer Infant Carriers Due to Fall Hazard; Sold Exclusively at Target
The buckles on the infant carriers can break, posing a fall hazard to children.
- 2018-10-15USDAClass IDiscard A La Carte Foods gumbo and jambalaya products
Produced Without Benefit of Inspection
- 2018-10-04CPSCBCI Burke Company, of Fond du Lac, Wis.Metal Playground Climbers Recalled by BCI Burke Due to Strangulation Hazard (Recall Alert)
The two welded handgrip locations at the top of the climbers can be too large creating a strangulation hazard. A child's body could become lodged in these openings, posing a strangulation hazard.
- 2018-10-03FDA-DeviceSwissray MedicalClass IIddR Formula B X-ray System, ddR Formula B Product Usage: X-ray system used for imaging
Possible injury due to movement of the arm, calibration loss and communication loss.
- 2018-10-03FDA-FoodConfidence Inc./Confidence U.S.A. Inc.Class IIFP0392, For-Men-10, All Natural Formula to Overall Men's Health, A Dietary Supplement, 60 Tablets, UPC: 8 92483 00139 7
Product contains undeclared ingredients, Hydroxypropyl Methylcellulose (HPMC), Titanium Dioxide, Polyethylene Glycol (PEG), Triacetin, FD&C Yellow #6 (Sunset Yellow FCF), FD&C Red #40 (Allura Red AC), FD&C Blue #1 (Aluminum Lake).
- 2018-10-02CPSCAAA Innovations, of Norwood N. J.AAA Innovations Recalls Promotional Cooler/Grills Due to Fire Hazard
The wooden cabinet surrounding the grill can catch fire, posing a fire hazard.
- 2018-10-01CPSCUberScientific LLC, of Kissimmee, Fla.UberScientific Recalls Topical Anesthetic Due to Failure to Meet Child Resistant Closure Requirement; Risk of Poisoning
The packaging is not child resistant as required by the Poison Prevention Packaging Act. The pain relieving cream and spray contain lidocaine, posing a risk of poisoning to young children if they put it on their skin or ingest it.
- 2018-09-28CPSCMentor International Corp. of Dongguan City, Guangdong Province, ChinaBoy Story Recalls Action Dolls Due to Choking Hazard
The joints on the vinyl dolls can break, creating broken pieces that pose a choking hazard to young children.
- 2018-09-26FDA-DeviceFresenius Medical Care Renal Therapies Group, LLCClass II2008T HEMODIALYSIS SYSTEM W/BIBAG, Part Number 190766, Applicable only with 2008T BlueStar Premium Upgrade Kit, Part Number 191138 Product Usage: Indicated for acute and chronic dialysis therapy.
In the hemodialysis machine during the cleaning/disinfection program, when there is a power failure or interruption, the dialysis program button should be greyed out when the machine is powered up and a mandatory rinse should be required. However, if a power failure or interruption occurs during the cleaning/disinfection program with the auto-start feature enabled, the machine enters the dialysis program even though the dialysis program button is disabled and the mandatory rinse has not been performed. As a result, disinfecting chemical may not be completely removed from the machine before starting a treatment and disinfectant could exist in the dialysate delivered to the patient.
- 2018-09-26FDA-DeviceSwissray MedicalClass IIddR Formula B X-ray System, Model ddR Formula B X-ray system used for imaging
Potential for bucky (the part that holds the grid and is moveable to position the patient) moving unexpectedly.
- 2018-09-26FDA-DeviceStryker Medical Division of Stryker CorporationClass IIIsoFlex LAL Support Surface, Model Number 2860 Product Usage: : The IsoFlex LAL support surface assists in the prevention and treatment of all pressure injuries (including stages 1,2,3,4, unstageable injury, and deep tissue injury) and is recommended to be implemented in combination with clinical evaluation of risk factors and skin assessments made by a health care professional. This support surface is for use with human patients with existing or at risk of incurring pressure injuries. Th
Certain 2860 IsoFlex LAL support surfaces were assembled with a non-conforming fire barrier.
- 2018-09-26FDA-DeviceLeica Microsystems, Inc.Class IILeica M525 F20 Surgical Microscope System
The firm received complaints that the instrument tipped over when the swing arm was fully extended.
- 2018-09-26FDA-DrugBeaumont Bio-med, Inc.Class IIArthritis Pain Relief Homeopathic Formula, 2 FL. OZ. (59.2 mL) per amber glass oral spray bottle, Distributed by Beaumont Bio-Med, Inc., Waukon, IA 52172; NDC 58066-7042-7
CGMP Deviations: products manufactured by contract manufacturer under conditions that could result in possible microbial contamination.
- 2018-09-26FDA-DrugBeaumont Bio-med, Inc.Class IIColds & Flu Response Homeopathic Formula, 2 FL. OZ. (59.2 mL) per amber glass oral spray bottle, Distributed by Beaumont Bio-Med, Inc., Waukon, IA 52172; NDC 58066-7012-7
CGMP Deviations: products manufactured by contract manufacturer under conditions that could result in possible microbial contamination.
- 2018-09-26FDA-DrugBeaumont Bio-med, Inc.Class IIAllergy & Hay Fever Relief Homeopathic Formula, 2 FL. OZ. (59.2 mL) per amber glass oral spray bottle, Distributed by Beaumont Bio-Med, Inc., Waukon, IA 52172; NDC 58066-7011-7
CGMP Deviations: products manufactured by contract manufacturer under conditions that could result in possible microbial contamination.
- 2018-09-26FDA-DrugBeaumont Bio-med, Inc.Class IIMuscle & Joint Pain Relief Homeopathic Formula, 2 FL. OZ. (59.2 mL) per amber glass oral spray bottle, Distributed by Beaumont Bio-Med, Inc., Waukon, IA 52172; NDC 58066-7041-7
CGMP Deviations: products manufactured by contract manufacturer under conditions that could result in possible microbial contamination.
- 2018-09-26FDA-DrugBeaumont Bio-med, Inc.Class IIDiarrhea Response Homeopathic Formula, 2 FL. OZ. (59.2 mL) per amber glass oral spray bottle, Distributed by Beaumont Bio-Med, Inc., Waukon, IA 52172; NDC 58066-7022-7
CGMP Deviations: products manufactured by contract manufacturer under conditions that could result in possible microbial contamination.
- 2018-09-26FDA-DrugBeaumont Bio-med, Inc.Class IISore Throat & Laryngitis Response Homeopathic Formula, 2 FL. OZ. (59.2 mL) per amber glass oral spray bottle, Distributed by Beaumont Bio-Med, Inc., Waukon, IA 52172; NDC 58066-7014-7
CGMP Deviations: products manufactured by contract manufacturer under conditions that could result in possible microbial contamination.
- 2018-09-26FDA-DrugBeaumont Bio-med, Inc.Class IISinus Response Homeopathic Formula, 2 FL. OZ. (59.2 mL) per amber glass oral spray bottle, Distributed by Beaumont Bio-Med, Inc., Waukon, IA 52172; NDC 58066-7013-7
CGMP Deviations: products manufactured by contract manufacturer under conditions that could result in possible microbial contamination.
- 2018-09-26FDA-DrugBeaumont Bio-med, Inc.Class IISkin Irritation & Itch Response Homeopathic Formula, 2 FL. OZ. (59.2 mL) per amber glass oral spray bottle, Distributed by Beaumont Bio-Med, Inc., Waukon, IA 52172; NDC 58066-7002-7
CGMP Deviations: products manufactured by contract manufacturer under conditions that could result in possible microbial contamination.
- 2018-09-26CPSCStrategic Orient Sourcing, of ChinaBoy Scouts of America Recalls Neckerchief Slides Due to Violation of Federal Lead Content Ban
The colored enamel on the neckerchief slides contains levels of lead that exceed the federal lead content ban. Lead is toxic if ingested by young children and can cause adverse health issues.
- 2018-09-25CPSCDesert Harvest Inc., of Hillsborough, N.C.Desert Harvest Recalls Reléveum Skin Repair Cream Due to Failure to Meet Child Resistant Closure Requirements
The bottles are not child resistant as required by the Poison Prevention Packaging Act, posing a poisoning risk if the contents are swallowed by young children.
- 2018-09-20CPSCDongguan Sureon Trading Limited, of ChinaWeeplay Kids Recalls Children's Coveralls Due to Choking Hazard
The bunny applique on the children's coveralls can detach, posing a choking hazard to young children.
- 2018-09-20USDAClass IIThrow out Zweigle's olive loaf pork products
Unfit for Human Consumption
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