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.
- 2023-07-26FDA-DeviceMEDLINE INDUSTRIES, LP - NorthfieldClass IIMedline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: a) CVC INFANT INSERTION PACK, Model Number CVI4770A; b) INSERTION BUNDLE, Model Number DT21275; c) VA MAINTENANCE PACK, Model Number EBSI1382; d) MIDLINE DRESSING CHANGE KIT, Model Number EBSI1464;
Probe covers for use during diagnostic ultrasound procedures may have an inadequate barrier at the seams.
- 2023-07-26FDA-DeviceMEDLINE INDUSTRIES, LP - NorthfieldClass IIMedline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: a) VEIN KIT, Model Number DYNJ55841B; b) FACELIFT PACK, Model Number DYNJ55954B; c) CLOT RETRIEVAL PACK, Model Number DYNJ56140B; d) VENOUS PACK, Model Number DYNJ56260B; e) WMC ULTRASOUND PACK, Model Number DYNJ56392; f) WMC ULTRASOUND PACK, Model Number DYNJ56392A; g) WMC ULTRASOUND PACK, Model Number DYNJ56392B; h) ULTRASOUND KIT-LF, Model Number DYNJ56507B; i) EVLT PACK, Model Number DYNJ56548B;
Probe covers for use during diagnostic ultrasound procedures may have an inadequate barrier at the seams.
- 2023-07-26FDA-DeviceMEDLINE INDUSTRIES, LP - NorthfieldClass IIMedline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: a. NORTON CHILDRENS CATH LAB-LF, Model Number 00-401185Q; b. PERCUTANEOUS VASCULAR CDS, Model Number CDS840487I; c. BAPTIST SOUTH OPEN HEART CV PK, Model Number CDS983147I; d. ENDOVASCULAR CDS, Model Number CDS983394I; e. ENDOVASCULAR CDS, Model Number CDS983394J; f. ENDOVASCULAR CDS, Model Number CDS983394K; g. OPEN HEART CDS, Model Number CDS983513F; h. OPEN HEART ANESTHESIA PACK, Model Number CDS983
Probe covers for use during diagnostic ultrasound procedures may have an inadequate barrier at the seams.
- 2023-07-26FDA-DeviceCardinal Health 200, LLCClass IINovaPlus Infant Heel Warmer, Instant Squeeze Activation, Catalog Number V11460-010
Cardinal Health has received an increase in burst/leaking complaints from mid-April to May regarding the above listed lot of the Novalplus Infant Heel Warmer with tape.
- 2023-07-20CPSCWilliams-Sonoma Inc., d/b/a Pottery Barn Kids, of San Francisco, CaliforniaPottery Barn Kids Recalls Penny Convertible Cribs Due to Laceration Hazard (Recall Alert)
The cribs' end panel can become loose exposing sharp edges, posing a laceration hazard to children.
- 2023-07-20CPSCSOOJIMUS LLC, d/b/a CUPKIN, of Bothell, WashingtonSoojimus Recalls CUPKIN Stainless Steel Children's Cups Due to Violation of Federal Lead Content Ban (Recall Alert)
The stainless-steel cups contain levels of lead that exceed the federal lead content ban. Lead is toxic if ingested by young children and can cause adverse health effects.
- 2023-07-19FDA-DrugK.C. Pharmaceuticals, IncClass IIOriginal Eye Drops; Redness Reliever; (Tetrahydrozoline HCl), 0.05%, 0.5 FL OZ (15mL); distributed by a) Original Formula Eye Drops, DG health, DISTRIBUTED BY OLD EAST MAIN CO, 100 MISSION RIDGE, GOODLETTSVILLE, TN 37072, UPC 0 95072 00556 5; b) Publix, DISTRIBUTED BY PUBLIX SUPER MARKETS, INC, 3300 PUBLIX CORPORATE PARKWAY, LAKELAND, FL 33811, UPC 0 41415 01076 5; c) sterile eye drops, Original Formula, sunmark, Distributed by McKesson, 6555 State Highway 161, Irving, TX 75039, UPC 0 10939 1673
CGMP Deviations: good manufacturing deficiencies related to a lack of documentation of the fill line.
- 2023-07-12FDA-DeviceDATEX--OHMEDA, INC.Class IIGiraffe OmniBed Carestation CS1, Model Numbers: a. 2082844-001-XXX, b. 2074920-001-XXXXXX, c. M1050205, d. M1135822, e. M1145475, f. M1145476, g. M1235957, h. M1149051, i. M1146098; Labeled as the following: GIRAFFE OMNIBED CARESTATION CS1, GIRAFFE OMNIBED CARESTATION, GIRAFFE OMNIBED, GIRAFFE OMNIBED CS1, OMNI G 115/230V SERVO2 CARESTATION, ASSY-LAU, OMNIBED CHINA EBASE S HUMID, Manufacturing assembly - Make, OBSOLETE-Omnibed Czech Servo O2 Nist/Scale/Re-usable Probe/SW w/port ho
GE HealthCare has become aware of the potential that an incorrect type of secondary latch could have been installed on the northeast (NE) and/or northwest (NW) bedside panels for certain Giraffe OmniBed and Giraffe OmniBed Carestation devices
- 2023-07-12FDA-FoodNewly Weds Foods, Inc.Class IG12668 MCDONALD'S MCRIB SPICE #777 46.50 BAG
Products may contain Salmonella
- 2023-07-06CPSCwoom Bikes USA, of Austin, Texaswoom Bikes USA Recalls woom ORIGINAL Kids' Bicycles Due to Fall Hazard
The stem and handlebar on the bikes can detach and cause riders to lose control, posing a fall hazard.
- 2023-06-29CPSCCaTeam, of Oak Harbor, WashingtonCaTeam Recalls Canvas Baby Hammock Swings Due to Suffocation Hazard; Violation of Safe Sleep for Babies Act on Inclined Infant Sleep Products
The inclined sleeper is a banned hazardous product under the Safe Sleep for Babies Act since the product was marketed for infant sleep and has an incline angle greater than 10 degrees. Infant fatalities have occurred in inclined sleepers after the infants rolled from their back to their stomach or side while unrestrained, or under other circumstances.
- 2023-06-29CPSCBose Corporation, of Framingham, Mass.Bose Recalls Acoustimass®, Lifestyle® and Companion™ Bass Modules Due to Fire Hazard
The speaker's electrical components can fail, posing a fire hazard.
- 2023-06-28FDA-DeviceDraeger Medical Systems, Inc.Class IIDraeger Softbed Resuscitaire and/or Birthing Room Warmer with Scale [Model(s): RW82VHA-1, RW82VHA-1C, RW82VHA-1D, RW82-1, RW82-1C, RW82-1D, WBR82-1 and WBR82-1C]
The Resuscitaire Infant Radiant Warmer with the optional scale could display inaccurate weight values.
- 2023-06-28FDA-FoodENTRINSIC HEALTH SOLUTION INCClass IIenterade Advanced Oncology Formula; Original Vanilla Flavor; Medical Food; Helps manage and maintain GI function; 8 FL OZ (237 mL); Recommended Use: Use as directed by your doctor, enterade is a medical food for patients under the supervision of a physician; Refrigerate after opening; Ingredients: Water, amino acid blend (L-Valine, L-Aspartic Acid, L-Serine, L-Threonine, L-Tyrosine), natural flavor, sodium chloride, sodium citrate, potassium chloride, magnesium chloride, calcium chloride, stevia
Potential for the product to develop mold and spoil.
- 2023-06-28FDA-FoodNutricia North AmericaClass IITYR Anamix Early Years infant formula Net Wt. 14.1 oz (400g) UPC: 749735002186 Product is a powder packed metal cans. 6 cans per case.
Infant formula contains undeclared tyrosine
- 2023-06-22CPSCInfanttech, of Montebello, CaliforniaInfanttech Recalls Zooby Video Baby Monitors for Cars Due to Fire Hazard (Recall Alert)
The baby monitor's battery can malfunction, overheat and burst, posing a fire hazard.
- 2023-06-22CPSCSound Around Inc., of Brooklyn, New YorkSound Around Recalls Children's Multi-Purpose Helmets Due to Risk of Head Injury
The recalled helmets do not comply with the positional stability requirements of the U.S. CPSC federal safety standard for bicycle helmets. The helmets can fail to protect in the event of a crash, posing a risk of head injury.
- 2023-06-22CPSCZuru LLC, of El Segundo, CaliforniaZuru Recalls 7.5 Million Baby Shark and Mini Baby Shark Bath Toys With Hard Plastic Top Fins Due to Risk of Impalement, Laceration and Puncture Injuries to Children
When using the recalled bath toys, particularly in a bathtub or wading pool, a child can slip and fall or sit onto the hard plastic top fin of the shark, posing risks of impalement, lacerations and punctures.
- 2023-06-22CPSCMichael Giordano International Inc., of Miami, FloridaBoost The Mood Ceramic Mugs Recalled by Michael Giordano International Due to Fire Hazard
The ceramic mugs are mislabeled as microwave safe. If microwaved, the metallic print on the mug can spark, posing a fire hazard.
- 2023-06-22CPSCProdigy Innovation LLC, of Princeton, New JerseyNationwide Pharmaceutical Recalls Iron Dietary Supplements Due to Failure to Meet Child Resistant Packaging Requirement; Risk of Poisoning
The recalled dietary supplements contain iron which must be in child-resistant packaging as required by the Poison Prevention Packaging Act (PPPA). The packaging of the products is not child-resistant, posing a risk of poisoning if the contents are swallowed by young children.
- 2023-06-14FDA-DeviceBecton Dickinson & Co.Class IIBD Veritor System for Rapid Detection of SARS-CoV-2 & Flu A+B, 30 Single Use Test Devices- Intended for the in vitro, simultaneous qualitative detection and differentiation of SARS-CoV-2 nucleocapsid antigen and influenza A and/or B Catalog Number: 256088
IFU- Instructions for Use (IFU) package insert and both the IFU packaged with the test kit and the electronic version on the BD website not approved by FDA,specifically describing specimen type, could cause use of the test with invalid specimen types, which may produce false positive or false negative results.Erroneous results can cause a delay in diagnosis or treatment
- 2023-06-14FDA-DeviceBearCare, Inc.Class IWalnut Wearable Smart Thermometer, intended for continuous chest temperature monitoring of children ages 0-6 years in non-emergency medical situations, Model Number WT20
There have been reports of skin burns to children wearing the device.
- 2023-06-14FDA-FoodNature's EnergyClass IINature's Energy Children's Chewable Colostrum Orange Creamsicle, 180 count, UPC 804879183969 GTIN 860008676993
Label declares bovine colostrum but does not declare milk allergen.
- 2023-06-14FDA-FoodNature's EnergyClass IINature's Energy Children's Chewable Colostrum Chocolate, 180 count, UPC 804879183952 GTIN 860008676986
Label declares bovine colostrum but does not declare milk allergen.
- 2023-06-14FDA-FoodNature's EnergyClass IINature's Energy Children's Chewable Colostrum Berry, 180 count, UPC 804879183945 GTIN 860008676979
Label declares bovine colostrum but does not declare milk allergen.
- 2023-06-08CPSCLittle Cotton Clothes, of United KingdomChildren's Pajamas and Nightdresses Recalled Due to Violation of Federal Flammability Standards and Burn Hazard; Imported by Little Cotton Clothes (Recall Alert)
The recalled children's pajamas and nightdresses fail to meet the federal flammability standards for children's sleepwear, posing a risk of burn injuries to children.
- 2023-06-08CPSCGroupe Minimome, dba Deux Par Deux, of CanadaChildren's Pajamas Recalled Due to Violation of Federal Flammability Standards and Burn Hazard; Imported by Deux Par Deux (Recall Alert)
The recalled children's pajamas fail to meet the federal flammability standards for children's sleepwear, posing a risk of burn injuries to children.
- 2023-06-08CPSCYiwu Jingtong Maternal and Infant Products Co. Ltd., of ChinaTopGlore Recalls Narskido Infant Bath Seats Due to Drowning Hazard; Sold Exclusively on Amazon.com (Recall Alert)
The bath seats fail to meet the federal safety standard for infant bath seats, including requirements for stability and leg openings, and can tip over while in use, posing a drowning hazard to babies.
- 2023-06-02USDAClass IDo not eat TorTrix pork rinds
Import Violation
- 2023-06-01CPSCJetson Electric Bikes, of Brooklyn, New YorkJetson Electric Bikes Recalls Nova and Star 3-Wheel Kick Children's Scooters Due to Fall Hazard
The rear wheel can loosen or fall off the scooter, posing a fall hazard to children.
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