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.

2020-05-20FDA-DeviceCook Inc.Class II
Formula 418 Renal Balloon-Expandable Stent, RPN FOR418-18-80-6-12, Order Number (GPN) G56611 Balloon-expandable stent made of 316L stainless steel with a slotted tube configuration. It is pre-mounted on an over-the-wire balloon catheter, which serves as the delivery system. The stent is positioned between two radiopaque marker bands, which are located inside the balloon at the proximal and distal tapers of the balloon.
The firm received complaints on five devices from one specific lot where the stent dislodged from the balloon delivery system prior to deployment. Use of affected product may lead to increased procedural time and additional intervention to remove a stent that dislodged within an unintended location.
2020-05-20FDA-DeviceStryker Medical Division of Stryker CorporationClass II
Stryker Power-PRO TL cot-powered ambulance cot Model Number 6550 - Product Usage: is a powered wheeled stretcher that is intended to support and transport the entire body of a traumatized, ambulatory or non-ambulatory human patient (includes infants and adults).
Ambulance Cots may not meet crash test standard BS EN 1789
2020-05-20CPSCStargate Apparel, of New York
Bunz Kidz Children's Sleepwear Sets Recalled by Stargate Apparel Due to Violation of Federal Flammability Standard; Burn Hazard
The children's sleepwear sets fail to meet the federal flammability standard for children's sleepwear which requires sleepwear to be either snug-fitting or flame resistant, posing a risk of burn injuries to children.
2020-05-14CPSCOrganic Pure Oil, of Santa Ana, Calif.
Organic Pure Oil Recalls Wintergreen Essential Oil Due to Failure to Meet Child Resistant Packaging Requirement; Risk of Poisoning; Sold Exclusively on Amazon.com (Recall Alert)
The product contains the substance methyl salicylate which must be in child resistant packaging as required by the Poison Prevention Packaging Act (PPPA). The packaging of the product is not child resistant, posing a risk of poisoning if the contents are swallowed by young children.
2020-05-14CPSCW8 Distributing dba Jade Bloom, of Draper, Utah
W8 Distributing Recalls Jade Bloom Wintergreen and Birch Sweet Essential Oils Due to Failure to Meet Child Resistant Packaging Requirement; Risk of Poisoning (Recall Alert)
The products contain the substance methyl salicylate 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.
2020-05-14CPSCAromatics International LLC, of Florence, Mont.
Aromatics International Recalls Wintergreen Essential Oil Due to Failure to Meet Child Resistant Packaging Requirement; Risk of Poisoning (Recall Alert)
The product contains the substance methyl salicylate which must be in child resistant packaging as required by the Poison Prevention Packaging Act (PPPA). The packaging of the product is not child resistant, posing a risk of poisoning if the contents are swallowed by young children.
2020-05-14CPSCFlyBar Inc., of Freehold, N.J. (owns Swurfer brand)
Flybar Recalls Swurfer Baby and Toddler Swings Due to Fall Hazard
The plastic stopper on the bottom of the swing rope that holds the swing seat in place can detach, posing a fall hazard to the swing's occupant.
2020-05-13CPSCHodedah Import Inc., of Brooklyn, N.Y.
Hodedah Recalls HI4DR 4-Drawer Chests Due to Tip-Over and Entrapment Hazards; Remedies May Be Delayed Due to COVID-19 Restrictions; Keep Product Away from Children
The recalled chest is unstable if it is not anchored to the wall, posing tip-over and entrapment hazards that may result in death or serious injuries to children. The chests do not comply with the performance requirements of the U.S. voluntary industry standard (ASTM 2057-19).
2020-05-12USDAPublic Health Alert
FSIS Issues Public Health Alert for Raw Beef Ravioli Products Due to Possible E. Coli O157:H7 Contamination
Product Contamination
2020-05-07CPSCSobeauty Inc., of Port Jefferson Station, N.Y.
Sobeauty Recalls "Mag Cube" Magnetic Ball Sets Due to Risk of Ingestion by Children That Could Cause Serious and Permanent Intestinal Injuries or Death (Recall Alert)
The recalled magnet sets contain high-powered magnets and violate the federal standard for children's toys. When two or more high-powered magnets are swallowed, they can link together inside a child's intestines and clamp onto body tissues, causing intestinal obstructions, perforations, sepsis and death. Internal injury from magnets can pose serious lifelong health effects.
2020-05-06FDA-DeviceSmiths Medical ASD Inc.Class II
Portex Lumbar Puncture Tray. Anesthesia Conduction Kit. 4826PL-20 - Product Usage: Portex lumbar puncture trays provide all the materials necessary to measure cerebrospinal fluid pressure and/or collect cerebrospinal fluid specimens. Key components include skin prep materials, lancet-point needle, manometer with stopcock and extension set, and specimen vials.
Cases of Portex¿ Lumbar Puncture Tray Child, SKU #4826PL-20 had been mislabeled with invalid information. The product was correct, but the inner trays were labeled as 4824PL-20 instead of 4826PL-20.
2020-05-06FDA-DeviceWELCH ALLYN, INC/MORTARAClass II
Q-Stress/XScribe. Q-Stress or XScribe is a diagnostic device capable of real time ECG display, heart rate measurement, ST analysis and ventricular ectopic beat detection using wired or wireless acquisition modules.
Impacted Welch Allyn products may not meet the Defibrillation Withstand requirements of EN/IEC 60601-2-25 Medical Electrical Equipment.
2020-05-06FDA-DeviceWELCH ALLYN, INC/MORTARAClass II
Lead diagnostic electrocardiograph under the following device names: ELI 10, ELI 350, ELI 150c, ELI 250c, ELI 230, ELI 280, ELI 380, R-Scribe and Connex Cardio. Product Usage: A non-invasive prescription device indicated for use to acquire, analyze, display, transmit and print electrocardiograms.
Impacted Welch Allyn products may not meet the Defibrillation Withstand requirements of EN/IEC 60601-2-25 Medical Electrical Equipment.
2020-05-06CPSCPrepac Manufacturing Ltd., of Canada
Prepac Recalls 4-Drawer Chests Due to Tip-Over and Entrapment Hazards. In-Home Remedy May Be Delayed Due to COVID-19 Restrictions; Keep Product Away from Children
The recalled chests are unstable and can tip over if not anchored to the wall, posing serious tip-over and entrapment hazards that can result in death or injuries to children.
2020-04-30CPSCEssential Trading Post, of New Bedford, Mass.
Essential Trading Post Recalls Wintergreen and Birch Essential Oils Due to Failure to Meet Child Resistant Packaging Requirement; Risk of Poisoning (Recall Alert)
The products contain the substance methyl salicylate which must be in child resistant packaging as required by the Poison Prevention Packaging Act (PPPA). The packaging of the products are not child resistant, posing a risk of poisoning if the contents are swallowed by young children.
2020-04-30CPSCXimi Vogue LLC, of Doral, Fla.
Ximi Vogue Recalls Children's Neck Pillows Due to Violation of the Federal Lead Paint Ban; Risk of Poisoning
Paint on the zippers and zipper pulls contains levels of lead that exceed the federal lead paint ban. Lead is toxic if ingested by young children and can cause adverse health effects.
2020-04-29FDA-DeviceFresenius Medical Care Holdings, Inc.Class II
Fresenius 2008T BlueStar Hemodialysis Machine Part Number Description: 191124 2008T HD SYS. CDX BLUEST AR; 191126 2008T HD SYS. CDX W/BIBAG BLUEST AR; 191128 2008T HD SYS. W/O CDX BLUEST AR; 191130 2008T HD SYS. W/O CDX W/BIBAG BLUEST AR
A "Remove USB Device 2" false alarm may be displayed when no USB device or a non-powered USB device is connected to the USB port on the rear of the machine
2020-04-29FDA-DeviceFresenius Medical Care Holdings, Inc.Class II
Fresenius 2008T Hemodialysis Machine: Part Number Description 190573 2008T HEMODIAL YSIS SYS. OLC/DIASAFE PLUS; 190713 2008T HEMODIAL YSIS SYS., with CDX; 190766 2008T HEMODIAL YSIS SYSTEM W/BIBAG; 190858 2008T HEMODIAL YSIS SYSTEM WITHOUT CDX; 190895 2008T GEN 2 BIBAG WITHOUT CDX; 190908 2008T HD System With CDX, CAN
A "Remove USB Device 2" false alarm may be displayed when no USB device or a non-powered USB device is connected to the USB port on the rear of the machine
2020-04-29FDA-DrugYusef Manufacturing Laboratories, LLCClass II
PEPPERMINT LIP MOISTURIZER (oxybenzone (4%) and Octinoxate (7%) SPF 15, 4.2 g tube, labeled as a) Bimark Inc., bimark.com; b) NOCO TRAIL REPORT, www.NoCoTrailReport.org; c) Herbruck's, d) St. Mark's Outpatient Surgery Center, 1250 East 3900 South Suite 100, Salt Lake City, UT 84124, e) Trust Company Oklahoma, trustok.com, f) Creekside Dental, www.creeksidedentalkennewick.com, g) Children's Healthcare of Atlanta Hughes Spalding, h) Great Smiles Orthodontics, Dr. Savage & Dr. Weissman, Crestline.
Superpotent drug: This lot of SPF containing lip balm contains up to 150% of the label claim for active ingredient Oxybenzone.
2020-04-23CPSCBioFinest, of Lindon, Utah
BioFinest Recalls Wintergreen Essential Oil Due to Failure to Meet Child Resistant Packaging Requirement; Risk of Poisoning; Sold Exclusively at Biofinest.com (Recall Alert)
The product contains the substance methyl salicylate which must be in child resistant packaging as required by the Poison Prevention Packaging Act (PPPA). The packaging of the product is not child resistant, posing a risk of poisoning if the contents are swallowed by young children.
2020-04-23CPSCNaturo Sciences, of Wilmington, Del.
Naturo Sciences Recalls Eiji Essentials Wintergreen Oil Due to Failure to Meet Child Resistant Packaging Requirement; Risk of Poisoning (Recall Alert)
The product contains the substance methyl salicylate which must be in child resistant packaging as required by the Poison Prevention Packaging Act (PPPA). The packaging of the product is not child resistant, posing a risk of poisoning if the contents are swallowed by young children.
2020-04-23CPSCLiquiFab, of Canada
Natural Health Partners Recalls Dr. Mercola Wintergreen Essential Oils Due to Failure to Meet Child Resistant Packaging Requirement; Risk of Poisoning (Recall Alert)
The products contain the substance methyl salicylate which must be in child resistant packaging as required by the Poison Prevention Packaging Act (PPPA). The packaging of the product is not child resistant, posing a risk of poisoning if the contents are swallowed by young children.
2020-04-16CPSCThe Vitamin Shoppe, of Secaucus, N.J.
The Vitamin Shoppe Recalls Energy Formula Multivitamins Due to Failure to Meet Child Resistant Packaging Requirement; Risk of Poisoning (Recall Alert)
The product is a dietary supplement containing iron which must be in child resistant packaging as required by the Poison Prevention Packaging Act (PPPA). The packaging of the product is not child resistant, posing a poisoning risk if the contents are swallowed by young children.
2020-04-16CPSCDr. Adorable, of Chicago, Ill.
Dr. Adorable Recalls Sweet Birch Essential Oil Due to Failure to Meet Child Resistant Packaging Requirement; Risk of Poisoning; Sold Exclusively on Amazon.com (Recall Alert)
The product contains the substance methyl salicylate which must be in child resistant packaging as required by the Poison Prevention Packaging Act (PPPA). The packaging of the product is not child resistant, posing a risk of poisoning if the contents are swallowed by young children.
2020-04-16CPSCWyndmere Naturals Inc., of New Hope, Minn.
Wyndmere Naturals Recalls Birch Sweet Essential Oil and Aches & Pains Synergistic Essential Oil Blend Due to Failure to Meet Child Resistant Packaging Requirement; Risk of Poisoning
The product contains the substance methyl salicylate which must be in child resistant packaging as required by the Poison Prevention Packaging Act (PPPA). The packaging of the product is not child resistant, posing a risk of poisoning if the contents are swallowed by young children.
2020-04-15FDA-DeviceJames Leckey Design LtdClass II
Firefly Floorsitter, Firefly Splashy Bathseat, Firefly GoTo Seat - Product Usage: The Splashy Bath-Seat is a Portable bath seat for children aged 1-8, The GoTo Seat is a light-weight, portable, postural support seat for kids, aged between 1 and 8 with disabilities.
The firm received reports of a number of broken latches on the floorsitter.
2020-04-08FDA-DeviceBard Peripheral Vascular IncClass II
BD WAVELINQ 4F EndoAVF System, Arterial Catheter 50 cm, Venous Catheter 43 cm, Sterile EO, Rx only, Mfr. Bard Peripheral Vascular, Inc., Ref W04200, Lot S0053, UDI (01)00801741182754(17)210215(10)S0053 - Product Usage: The WavelinQ 4F EndoAVF System in indicated for the creation of an arteriovenous fistula (AVF) using concomitant ulnar artery and ulnar vein or concomitant radial artery and radial vein in patients with minimum artery and vein diameters of 2.0 mm at the fistula creation site who h
The firm has become aware of a potential problem with their venous and arterial magnetic catheters may be at risk of experiencing a magnetic deficiency, which may result in the magnets failing to attract to one another. This may result in procedural delay in obtaining or creating a functional fistula and need for additional contrast to perform the necessary fluoroscopy. This can pose an incremental risk of harm to a diabetic patient's kidney function.
2020-04-08FDA-FoodNutraBlend Foods, Inc. LLCClass III
Russian Bear 10000 Weight Gainer Formula Cookies and Cream flavor packed in 15lb bags
Products contain undeclared soy protein isolate.
2020-04-08FDA-FoodNutraBlend Foods, Inc. LLCClass III
Russian Bear 10000 Weight Gainer Formula Banana flavor packed in 15lb bags
Products contain undeclared soy protein isolate.
2020-04-08FDA-FoodNutraBlend Foods, Inc. LLCClass III
Russian Bear 10000 Weight Gainer Formula Strawberry flavor packed in 15lb bags
Products contain undeclared soy protein isolate.

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