Baby and kids' product recalls
6719 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.
- 2023-08-17CPSCThe Simplay3 Company, of Streetsboro, OhioThe Simplay3 Company Recalls Toddler Towers Due to Fall and Injury Hazards
The towers can tip over while in use posing fall and injury hazards to young children.
- 2023-08-17CPSCBell Station Interiors, dba Zipadee Kids, of Circleville, OhioZipadee Kids Recalls Convertible House Bed Frames and Montessori Floor Beds Due to Entrapment and Strangulation Hazards
The spindles used on the recalled beds are spaced at a distance that creates a serious entrapment hazard that can lead to strangulation and/or death to children. The design of the bed allows a child's torso to slip through the rail opening but will not allow their head to pass, posing entrapment and strangulation hazards that could result in death.
- 2023-08-10CPSCRestwell Mattress Co., of Eden Prairie, MinnesotaRestwell Mattress Recalls Room & Board Crib Mattresses Due to Suffocation Hazard for Infants; Failure to Comply with Federal Safety Standard for Crib Mattresses; Sold Exclusively at Room & Board (Recall Alert)
The recalled crib mattresses fail to comply with multiple provisions of the Federal Safety Standard for Crib Mattresses, including the firmness test and missing warnings and labels. The product poses a suffocation hazard to infants.
- 2023-08-10CPSCThe Children's Place, of Secaucus, New JerseyThe Children's Place Recalls Two Styles of Baby and Toddler Boy Basic Stretch Straight Leg Jeans Due to Choking Hazard
The metal snaps on the jeans can detach, posing a choking hazard to young children.
- 2023-08-09FDA-DeviceMEDLINE INDUSTRIES, LP - NorthfieldClass IICustom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel. Labeled as the following: a. CVC INFANT INSERTION PACK, Model Number: CVI4770A; b. INSERTION BUNDLE, Model Number: DT21275; c. MIDLINE DRESSING CHANGE KIT, Model Number: EBSI1464; d. MIDLINE INSERTION KIT, Model Number: DT20155; e. PICC LINE DRESSING TRAY, Model Number: DT22045; f. UNIVERSAL DRESSING PPE KIT, Model Number: DT22065; g. UNIVERSAL DRESSING & PPE KIT, Model Number:
Potential for the labeled sterile ultrasound gel component within packs to not meet sterility specifications.
- 2023-08-09FDA-DeviceMEDLINE INDUSTRIES, LP - NorthfieldClass IICustom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel. Labeled as the following: a. 18GX6" FEMORAL ART LINE KIT, Model Number: ART960; b. 20Gx3" RADIAL ART LINE KIT, Model Number: ART970; c. 20GX6" FEMORAL ART LINE KIT, Model Number: ART1165; d. 3" RADIAL ARTERIAL LINE KIT, Model Number: ART240A; e. 6" FEMORAL ARTERIAL LINE KIT, Model Number: ART245A, ART245B; f. A LINE TRAY, Model Number: ART690; g. A-LINE INSERTION TRAY, Model Number: ART645;
Potential for the labeled sterile ultrasound gel component within packs to not meet sterility specifications.
- 2023-08-09FDA-DeviceMEDLINE INDUSTRIES, LP - NorthfieldClass IICustom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel. Labeled as the following: a. DR. ROSEN VEIN PACK, Model Number: DYNJ67517; b. DR. VANBOSSE LOWER EXT PACK, Model Number: DYNJ51416B; c. DRAINAGE TRAY, Model Number: DYNJ42913, DYNJ42913A; d. ECMO PACK, Model Number: DYNJ61243; e. EGG RETRIEVAL PACK, Model Number: DYNJ66291, DYNJ66291A; f. EH TAVR PACK, Model Number: DYNJ57449A; g. ELVS PACK-LF, Model Number: DYNJ26940G; h. ENDO AAA HYBR
Potential for the labeled sterile ultrasound gel component within packs to not meet sterility specifications.
- 2023-08-09FDA-DrugCentral Admixture Pharmacy Services, Inc.Class IICARDIOPLEGIA SOLUTION, 70 mEq K, Modified St. Thomas Formula low potassium, IV Bag, Total Volume = 1000 mL, Rx only, Central Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Pheonix, AZ 85043, NDC: 72196-0210-1
Lack of assurance of sterility. Validation data for decontamination cycles is lacking.
- 2023-08-09FDA-DrugCentral Admixture Pharmacy Services, Inc.Class IICARDIOPLEGIA SOLUTION 122 mEq K, Modified St. Thomas Formula High Potassium, Total Volume = 1000 mL, IV Bag, Rx only, Central Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Pheonix, AZ 85043, NDC: 72196-0209-1
Lack of assurance of sterility. Validation data for decontamination cycles is lacking.
- 2023-08-09FDA-DrugCentral Admixture Pharmacy Services, Inc.Class IICardioplegia Solution del Nido Formula, IV Bag, Total Volume = 1,052.8 mL, FOR INTRACARDIAC PERFUSION USE ONLY, PLASMA-LYTE A 1000 mL, Mannitol 20% 16.3 mL, Sodium Bicarbonate 8.4% 13 mL, Potassium Chloride 2 mEq/mL 13 mL, Magnesium Sulfate 4.06 mEq/mL 4 mL, Lidocaine 2% 6.5 mL, Approx. Osmolarity 386 mOsm/L, Rx Only, Central Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Phoenix, AZ 85043, NDC: 72196-0202-1
Lack of assurance of sterility. Validation data for decontamination cycles is lacking.
- 2023-08-03CPSCPhilips Consumer Lifestyle B.V., of The NetherlandsPhilips Avent Digital Video Baby Monitors Recalled by Philips Personal Health Due to Burn Hazard
The rechargeable lithium-ion batteries in the Parent Unit monitors can overheat during charging, posing a risk of burns and property damage.
- 2023-08-02FDA-DeviceHamilton Medical, Inc.Class IHAMILTON C3 Ventilator REF 160005 Is intended to provide positive pressure ventilatory support to adults and pediatrics, and optionally infants and neonates
Due to a software anomaly after approximately 91 days of cumulative use, the ventilator may stop and enter the ambient mode without prior notice.
- 2023-08-02FDA-DeviceHamilton Medical, Inc.Class IHAMILTON C2 Ventilator Is intended to provide positive pressure ventilatory support to adults and pediatrics, and optionally infants and neonates
Due to a software anomaly after approximately 91 days of cumulative use, the ventilator may stop and enter the ambient mode without prior notice.
- 2023-08-02FDA-DeviceHamilton Medical, Inc.Class IHAMILTON T1 Ventilator REF 161006 1610060 161009 1610090 Is intended to provide positive pressure ventilatory support to adults and pediatrics, and optionally infants and neonates
Due to a software anomaly after approximately 91 days of cumulative use, the ventilator may stop and enter the ambient mode without prior notice.
- 2023-08-02FDA-DeviceHamilton Medical, Inc.Class IHAMILTON C1 Ventilator REF 161001 1610010 Is intended to provide positive pressure ventilatory support to adults and pediatrics, and optionally infants and neonates
Due to a software anomaly after approximately 91 days of cumulative use, the ventilator may stop and enter the ambient mode without prior notice.
- 2023-08-02FDA-FoodEmceta International Inc.Class IIINatural Systems, Naturasys MULTI VITAMIN HIGH POTENCY AND FORMULATION, Dietary Supplement 60 Tablets
FDA sample analysis of Natural Systems brand Multi Vitamin, 60 Tablets, found the magnesium content as 33.5% of the amount declared in label.
- 2023-07-27CPSCSoft Play LLC, of Huntersville, North CarolinaSoft Play Recalls Sky Wheels Due to Fall Hazard and Risk of Injury to Children (Recall Alert)
The Sky Wheels can become detached from the overhead rail on the play set, posing a fall hazard and risk of injury to children.
- 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.
Get notified about new baby recalls
Free weekly digest. We email when a new federal recall in this category — or anything else affecting your household — is published.
Get the Sunday Brief