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.
- 2024-01-17FDA-DeviceBaxter Healthcare CorporationClass IIPeri-Guard Repair Patch, Product Codes: a) PG1016 : 10 X 16 CMUS, TS b) PG1225: 12 X 25 CMUS, TS c) PG0404: 4 X 4 CMUS, TS d) PG0608: 6 X 8CMUS, TS e) PG0814: 8 X 14 CMUS, TS
Cardiovascular Surgery marketing brochure (US-AS46-220001) that was distributed for the products listed below contains inaccurate content that does not align with some of the products Instructions for Use (IFU) or Prescribing Information (PI).
- 2024-01-17FDA-DeviceBaxter Healthcare CorporationClass IIBaxter Flo-Thru Intraluminal Shunt, Product Codes: a) Product Code FT12100, 1.00 GLOBAL; b) Product Code FT12125, 1.25 GLOBAL; c) Product Code FT12150, 1.50 GLOBAL; d) Product Code FT12175, 1.75 GLOBAL; e) Product Code FT12200, 2.00 GLOBAL; f) Product Code FT12225, 2.25 GLOBAL; g) Product Code FT12250, 2.50 GLOBAL; h) Product Code FT12275, 2.75 GLOBAL; i) Product Code FT12300, 3.00 GLOBAL
Cardiovascular Surgery marketing brochure (US-AS46-220001) that was distributed for the products listed below contains inaccurate content that does not align with some of the products Instructions for Use (IFU) or Prescribing Information (PI).
- 2024-01-17FDA-DeviceBaxter Healthcare CorporationClass IIBaxter FloSeal Hemostatic Matrix RECOTHROM, Product Codes: a) ADS202105, 5mL-6 PK US b) ADS202110, 10mL US
Cardiovascular Surgery marketing brochure (US-AS46-220001) that was distributed for the products listed below contains inaccurate content that does not align with some of the products Instructions for Use (IFU) or Prescribing Information (PI).
- 2024-01-17FDA-DeviceBaxter Healthcare CorporationClass IIBaxter Floseal Hemostatic Matrix Fast Prep, Product Codes: a) ADS201844, 5 mL b) ADS201845, 10mL
Cardiovascular Surgery marketing brochure (US-AS46-220001) that was distributed for the products listed below contains inaccurate content that does not align with some of the products Instructions for Use (IFU) or Prescribing Information (PI).
- 2024-01-17FDA-DeviceBaxter Healthcare CorporationClass IIBaxter Preveleak Surgical Sealant, Product Codes: ADS201808
Cardiovascular Surgery marketing brochure (US-AS46-220001) that was distributed for the products listed below contains inaccurate content that does not align with some of the products Instructions for Use (IFU) or Prescribing Information (PI).
- 2024-01-17FDA-DeviceBaxter Healthcare CorporationClass IIBaxter Vascular Probe, Product Codes: a) 7081015: 8CM, 1- 1.5 MM GLOBAL, b) 7081520: 8CM, 1.5-2 MM GLOBAL, c) 7082025: 8CM, 2-2.5 MM GLOBAL, d) 7151015: 15CM, 1-1.5 MM GLOBAL, e) 7151520: 15CM, 1.5- 2 MM GLOBAL, f) 7152025: 15CM, 2- 2.5 MM GLOBAL, g) 7451015: 45CM, 1- 1.5 MM GLOBAL, h) 7451520: 45CM, 1.5- 2 MM GLOBAL, i) 7452025: 45CM, 2- 2.5 MM GLOBAL, j) 7081015ES: 8CM, 1-1.5 MM GLOBAL, k) 7081520ES: 8CM, 1.5- 2 MM GLOBAL, l) 7082025ES: 8CM, 2-
Cardiovascular Surgery marketing brochure (US-AS46-220001) that was distributed for the products listed below contains inaccurate content that does not align with some of the products Instructions for Use (IFU) or Prescribing Information (PI).
- 2024-01-17FDA-DeviceBaxter Healthcare CorporationClass IIBaxter Ostene Hemostasis Material, Product Codes: a) 1503831, 3.5 G; b) 1503832, 2.5 G; c) 1503833, 1.0 G
Cardiovascular Surgery marketing brochure (US-AS46-220001) that was distributed for the products listed below contains inaccurate content that does not align with some of the products Instructions for Use (IFU) or Prescribing Information (PI).
- 2024-01-17FDA-DeviceBaxter Healthcare CorporationClass IIBaxter Coseal Premix, Surgical Sealant, Product Codes: a) 934070; b) 934071; c) 934072
Cardiovascular Surgery marketing brochure (US-AS46-220001) that was distributed for the products listed below contains inaccurate content that does not align with some of the products Instructions for Use (IFU) or Prescribing Information (PI).
- 2024-01-17FDA-DeviceBaxter Healthcare CorporationClass IIBaxter Flo-Rester, Disposable internal vessel occluder, distributed in the following sizes: a) Product Code 50100: 12MM, 1.00 MM GLOBAL; b) Product Code 50150: 12MM, 1.50 MM GLOBAL; c) Product Code 50175: 12MM, 1.75 MM GLOBAL; d) Product Code 50200: 12MM, 2.00 MM GLOBAL; e) Product Code 50225: 12MM, 2.25 MM GLOBAL; f) Product Code 50250: 12MM, 2.50 MM GLOBAL; g) Product Code 50275: 12MM, 2.75 MM GLOBAL; h) Product Code 50300: 12MM, 3.00 MM GLOBAL; i) Product Code 5
Cardiovascular Surgery marketing brochure (US-AS46-220001) that was distributed for the products listed below contains inaccurate content that does not align with some of the products Instructions for Use (IFU) or Prescribing Information (PI).
- 2024-01-11CPSCXander Bicycle Corporation, DBA Retrospec, of Perris, CaliforniaRetrospec Recalls Kid's Bike Helmets Due to Risk of Head Injury; Violation of the Federal Safety Regulation for Bicycle Helmets
The molded plastic drain pan located at the bottom of the evaporator coil can overheat, melt and deform, posing a fire hazard.
- 2024-01-11CPSCNew Age Industries Co. LTD, of VietnamAlliance4Safety and 31 Furniture Companies Recall Millions of Plastic New Age Furniture Tip-over Restraint Kits Due to Tip-over and Entrapment Hazards to Children
The plastic zip tie used with the recalled furniture tip kits can become brittle or break, which can allow a clothing storage unit that is anchored to the wall to detach during a furniture tip-over event, posing a tip-over and entrapment hazard that can result in death or serious injuries to children.
- 2024-01-10FDA-FoodForemost Foods International, Inc.Class IIPamana Premium Marinated Baby Bangus (Deboned Marinated Baby Milkfish), Net Weight to be Weight at Time of Sale
Potential C. botulinum growth and toxin formation. Frozen bangus (milkfish) in reduced oxygen packaging does not contain instructions to keep frozen and instructions for proper thawing (e.g., "Important, keep frozen until used, thaw under refrigeration immediately before use.").
- 2024-01-04CPSCUBBCARE, of ChinaUBBCARE Play Yard Mattresses Recalled Due to Suffocation Hazard for Infants; Violation of the Federal Safety Regulation for Crib Mattresses; Sold Exclusively on Amazon.com by UBBCARE
The recalled play yard mattresses violate multiple provisions of the federal safety regulation for crib mattresses, including the thickness test, and are missing warnings and labels. The product poses a suffocation hazard to infants.
- 2024-01-03USDAClass IDon't eat Busseto Foods charcuterie sampler
Product Contamination
- 2023-12-22USDAClass IThrow out Scanga Meat ground beef products
Product Contamination
- 2023-12-21CPSCWhele LLC d/b/a Perch, of Boston, MassachusettsLitti City and Litti Pritti Dress-up Playsets and Prextex Slime Eggs Recalled Due to Violations of Federal Phthalates and Lead Content Bans; Imported by Perch, Amusty and Bingo Deals (Recall Alert)
All the dress-up playsets and the slime eggs contain levels of certain phthalates that exceed the federal phthalate standard. In addition, the Litti City teacher purse dress-up playset, the Litti Pritti handbag playset, and the slime eggs contain levels of lead that exceed the federal lead content ban. Lead and phthalates are toxic if ingested by young children and can cause adverse health effects.
- 2023-12-21CPSCMax Lead International Ltd., dba Brandline, of Dallas, TexasBrandline Recalls HEAO High Chairs Due to Risk of Suffocation, Entrapment and Laceration Hazards; Violation of the Federal Safety Standards; Sold Exclusively on Amazon.com
The high chairs pose a suffocation risk because they were marketed, intended, or designed for infant sleep, and they have an incline angle greater than 10 degrees in violation of the CPSC's Infant Sleep Products Rule and the Safe Sleep for Babies Act. In addition, the high chairs pose finger laceration and entrapment hazards as they failed to meet mandatory requirements under the high chair standard.
- 2023-12-20FDA-DeviceMaquet Medical Systems USAClass IICARDIOHELP-i Heart Lung Support System- A blood oxygenation and carbon dioxide removal system used to pump blood through the extracorporeal bypass circuit for circulatory and/or pulmonary support for periods appropriate to cardiopulmonary bypass Part Number: 701072780, (CARDIOHELP-I US); 701048012 (CARDIOHELP-I NON US)
Certain factory settings for the device were incorrectly described in the IFU-related to the warning limits for PVen and PAux, and the default settings for the venous bubble sensor (VBS) and the automatic lock in the Minimized Extracorporeal Circulation (MECC) ThApp
- 2023-12-14CPSCPolaris Industries Inc., of Medina, MinnesotaPolaris Industries Recalls RZR 200 Youth Recreational Off-Road Vehicles (ROVs) Due to Crash Hazard and Risk of Serious Injury
The steering system can lock up while in use, posing a crash hazard and risk of serious injury to children.
- 2023-12-13FDA-FoodGarden Of Life LlcClass IIGarden of Life, FYI ULTRA, ULTIMATE Joint & Cartilage Formula, Whole Food Dietary Supplement, 120 Ultra Zorbe VEGETARIAN CAPSULES
Undeclared Soy.
- 2023-12-13FDA-DrugKINDER FARMS LLCClass IIKinderMed INFANTS' PAIN & FEVER Acetaminophen, 160 mg per 5 mL bottles, Oral Suspension, Organic Cherry Flavor, 2 FL OZ (59 mL), Distributed By: KinderFarms, Redondo Beach, CA 90277, NDC 82673-096-02, UPC 850001805698.
Failed Impurities/Degradation Specifications
- 2023-12-13FDA-DrugKINDER FARMS LLCClass IIKinderMed KIDS' PAIN & FEVER Acetaminophen, 160 mg per 5 mL bottles, Oral Suspension, Organic Cherry Flavor, 4 FL OZ (118 mL), Distributed By: KinderFarms, Redondo Beach, CA 90277, NDC 82673-097-04, UPC 850001805728.
Failed Impurities/Degradation Specifications
- 2023-12-13FDA-DrugRight Value Drug Stores, LLC dba Carie Boyd's Prescription ShopClass IIILET Gel (Lidocaine HCL/Epinephrine Bitartrate/Tetracaine HCL 4%/0.18%/0.5% Topical Gel), Single-use Topical Syringe, 3mL syringe, 10/pack, Rx only, Carie Boyd Pharmaceuticals, 8400 Esters Blvd, Ste# 190, Irving, TX 75063, NDC73271-1003-1
Product Mix-up: Incorrect Product Formulation
- 2023-12-07CPSCHuangshan Yueyang Ecommerce Co. Ltd., of ChinaMoonsea Pack and Play Mattresses Recalled Due to Suffocation Hazard for Infants; Violation to the Federal Safety Regulation for Crib Mattresses; Sold Exclusively on Amazon.com by Moonseasleep (Recall Alert)
The recalled mattresses violate multiple provisions of the federal safety regulation for crib mattresses, including the thickness test and missing warnings and labels. The product poses a suffocation hazard to infants.
- 2023-12-07CPSCBugaboo North America Inc., of New YorkBugaboo Recalls Dragonfly Seat Strollers Due to Injury Hazard (Recall Alert)
In "parent-facing" mode, the backrest of the seat can move downward, placing the infant in a negative recline. In this situation, an unrestrained infant could tumble from the seat, posing an injury hazard.
- 2023-12-07CPSCVibe Bear, of ChinaVibe Bear Playyard Mattresses Recalled Due to Suffocation Hazards for Infants; Violation of the Federal Safety Regulation for Crib Mattresses; Sold Exclusively on Amazon.com by Vibe Bear (Recall Alert)
The recalled mattresses violate multiple provisions of the federal safety regulation for crib mattresses, including the firmness and thickness tests, and are missing warnings and labels. The product poses a suffocation hazard to infants.
- 2023-12-07CPSCPrimark U.S. Corp., of BostonPrimark Recalls Baby Rattles Due to Risk of Choking and Ingestion Hazards
The bottom portion of the recalled baby rattles can detach, posing choking and/or ingestion hazards.
- 2023-12-07CPSCMary Meyer Corporation, of Townshend, VermontMary Meyer Recalls Bubba Bull Plush Toys Due to Choking Hazard
The eyes of the plush toys can break off, posing a choking hazard to young children.
- 2023-12-06USDAClass IDo not eat Garland Ventures fried rice with chicken
Product Contamination
- 2023-12-05CPSCSoftfunch, of South KoreaFoiresoft Zebra Roller Blinds Recalled Due to Strangulation and Entanglement Hazards; Sold Exclusively on Amazon.com by Softfunch (Recall Alert)
The recalled roller blinds have looped operating cords that pose a strangulation hazard to children.
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