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.
- 2021-03-24FDA-FoodMinnesota Milk Bank for BabiesClass IIIMN Milk Bank for Babies Pasteurized Donor Human Milk. Volumne 4.0 fl oz., 120 mL
Pasteurized donor human milk may contain trace amounts of dextromethorphan.
- 2021-03-24NHTSA-EquipmentDionoDiono — Headrest May Break or Separate/FMVSS 213
A broken or separated headrest increases the risk of injury during a crash.
- 2021-03-18CPSCGenentech, a member of the Roche Group, of South San Francisco, Calif.Genentech Recalls Prescription Drug Evrysdi Due to Failure to Meet Child Resistant Packaging Requirements; Risk of Drug Exposure through Eye or Skin Absorption (Recall Alert)
The bottles containing the prescription drug can leak due to a fit issue between the press-in bottle adapter and bottleneck. If the bottle is leaking, there is a risk of drug exposure by contact with skin or eyes. Prescription drugs must be in child resistant packaging that prevents children from gaining access to the contents as required by the Poison Prevention Packaging Act (PPPA).
- 2021-03-17FDA-DeviceSunstar Americas, Inc.Class IISUNSTAR G.U.M. HYDRAL DRY MOUTH RELIEF On-the-go Oral Spray, 2 FL.OZ. UPC0 70942 30713 0 - Product Usage: The device is formulated with water, moisturizers /humectants including one plant-based moisture rich humectant, sweeteners and flavors that collectively have lubricating, moisturizing, soothing, and refreshing properties to help relieve and manage the symptoms of dry mouth.
The product may be contaminated with Burkholderia cepacia
- 2021-03-08NHTSA-EquipmentCombi USA, Inc.Combi USA, Inc. — Child Seat Webbing May Fail/FMVSS 213
A child that is not adequately restrained in a crash has an increased risk of injury.
- 2021-03-04CPSCCasa Collection Design Group Inc., of Brooklyn, N.Y.Casa Kids Recalls for Repair Cabina Bunk Beds Due to Fall Hazard (Recall Alert)
The screws that hold the bed's mattress foundation to the bed's guardrails can be loose and the mattress foundation can fall, posing a fall risk to children in the bunk bed.
- 2021-02-25CPSCMTIG Productions LLC, dba deSensua, of Buffalo, Wyo.MTIG Productions Recalls deSensua Wintergreen, Birch and Pain Soother 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.
- 2021-02-25CPSCDr. Reddy's Laboratories, Ltd., of IndiaDr. Reddy's Recalls Prescription Drug Blister Packages Due to Risk of Poisoning
The products are prescription medications that were labeled and distributed by Dr. Reddy's for institutional use only. The prescription medications were distributed by third party wholesalers to retail pharmacies and could have been dispensed to consumers. The packaging of the products is not child resistant and can pose a risk of poisoning if the contents are swallowed by young children.
- 2021-02-24CPSCShenzhen Haochen Industrial Co. Ltd., of ChinaSmartPool Recalls Children's Multi-Purpose Helmets Due to Risk of Head Injury
The recalled helmets were incorrectly advertised and marketed for children aged 2 years or older. However, the recalled helmets do not comply with minimum safety requirements for children younger than 5 and pose a risk of head injury to those children.
- 2021-02-17FDA-FoodOcean Beauty Seafoods LLCClass IIThe RETAIL package is black cardboard box and product is described as: Publix Parmesan-Crusted Wild Alaskan Salmon Fillets, Frozen, net wt. 12 oz. Each retail box has 2 individually vacuum-packaged portions of 5oz salmon with 1oz of glaze of soy sauce for each portion. The salmon and glaze are both in a vacuum-packed twin saddle clear pack. Product of USA. Distributed by Publix Super Markets, Inc. Lakeland, FL. UPC 41415 30245 7. The MASTER case (at warehouse and retail store level) is desc
Undeclared Soy
- 2021-02-17CPSCAnker Play Products, of Miami, FlaAnker Play Products Recalls 10-in-1 Incredible Inventions Science Kit Due to Violation of the Federal Lead Paint Ban
Paint on the red and blue magnet contains levels of lead that exceed the federal lead paint ban. Lead is toxic if ingested by young children and can cause adverse health issues. In addition, the product packaging lacks the required warning labels for magnets and balloons.
- 2021-02-10FDA-DeviceSmith & Nephew, Inc.Class IIVERSABOND AB 40 GRAMS FORMULATION 2, antibiotic infused bone cement, Product Number: 71271440 - Product Usage: VERSABOND is a medium viscosity bone cement which can be used for hip, knee, and shoulder implant fixation. VERSABOND AB includes the antibiotic- gentamycin.
Potential heat and humidity exposure. The affected lot contained an atypical sandy, flaky or grainy consistency when mixing.
- 2021-02-03FDA-DeviceQiagen Sciences LLCClass IItherascreen PIK3CA RGQ PCR Kit (23) US IVD product- aid clinicians in identifying breast cancer patients who may be eligible for treatment with PIQRAY (alpelisib) based on a PIK3CA Mutation Detected result. REF 873121
Kit may generate false Q546R mutation positive results caused by nonspecific molecular interactions within the Q546R higher than previously observed and described within the Instructions For Use.
- 2021-02-02USDAPublic Health AlertFSIS Issues Public Health Alert for Raw Ground Beef Product Due to Possible E. Coli O157:H7 Contamination
Product Contamination
- 2021-01-27CPSCEuromarket Designs,Inc. d/b/a/ CB2 of Chicago, Ill.CB2 Recalls Junction Tall Chests and Low Dressers Due to Tip-Over and Entrapment Hazards
The recalled chests and dressers are unstable if they are not anchored to the wall, posing serious tip-over and entrapment hazards that can result in death or injuries to children.
- 2021-01-20FDA-DeviceFresenius Medical Care Holdings, Inc.Class IICitrasate Liquid Acid concentrate drums, Product Code 13-2251 -CA - Product Usage: used in conjunction with Fresenius Renal Technologies Sodium Bicarbonate Concentrate in a compatible 45X dilution three-stream artificial kidney (hemodialysis) machine.
The deviation in conductivity for sodium level exceeds 0.6mS/cm from the theoretical conductivity (TCD) or approximately 6mEq/L of sodium from prescriptions that was previously communicated. Calcium concentration is below manufacturing specification.
- 2021-01-20FDA-DeviceFresenius Medical Care Holdings, Inc.Class IINaturalyte Liquid Acid concentrate drums, Product Code 13-3251-9 - Product Usage: used in conjunction with Fresenius Renal Technologies Sodium Bicarbonate Concentrate in a compatible 45X dilution three-stream artificial kidney (hemodialysis) machine.
The deviation in conductivity for sodium level exceeds 0.6mS/cm from the theoretical conductivity (TCD) or approximately 6mEq/L of sodium from prescriptions that was previously communicated. Calcium concentration is below manufacturing specification.
- 2021-01-20FDA-DeviceFresenius Medical Care Holdings, Inc.Class IINaturalyte Liquid Acid concentrate drums, Product Code 13-2251-0 - Product Usage: used in conjunction with Fresenius Renal Technologies Sodium Bicarbonate Concentrate in a compatible 45X dilution three-stream artificial kidney (hemodialysis) machine.
The deviation in conductivity for sodium level exceeds 0.6mS/cm from the theoretical conductivity (TCD) or approximately 6mEq/L of sodium from prescriptions that was previously communicated. Calcium concentration is below manufacturing specification.
- 2021-01-20FDA-DeviceFresenius Medical Care Holdings, Inc.Class IINaturalyte Liquid Acid concentrate bottles, Product Code 08-4231-0 - Product Usage: used in conjunction with Fresenius Renal Technologies Sodium Bicarbonate Concentrate in a compatible 45X dilution three-stream artificial kidney (hemodialysis) machine.
The deviation in conductivity for sodium level exceeds 0.6mS/cm from the theoretical conductivity (TCD) or approximately 6mEq/L of sodium from prescriptions that was previously communicated. Calcium concentration is below manufacturing specification.
- 2021-01-20FDA-DeviceFresenius Medical Care Holdings, Inc.Class IINaturalyte Liquid Acid concentrate bottles, Product Code 08-3251-9 - Product Usage: used in conjunction with Fresenius Renal Technologies Sodium Bicarbonate Concentrate in a compatible 45X dilution three-stream artificial kidney (hemodialysis) machine.
The deviation in conductivity for sodium level exceeds 0.6mS/cm from the theoretical conductivity (TCD) or approximately 6mEq/L of sodium from prescriptions that was previously communicated. Calcium concentration is below manufacturing specification.
- 2021-01-20FDA-DeviceFresenius Medical Care Holdings, Inc.Class IINaturalyte Liquid Acid concentrate bottles, Product Code 08-2351-8 - Product Usage: used in conjunction with Fresenius Renal Technologies Sodium Bicarbonate Concentrate in a compatible 45X dilution three-stream artificial kidney (hemodialysis) machine.
The deviation in conductivity for sodium level exceeds 0.6mS/cm from the theoretical conductivity (TCD) or approximately 6mEq/L of sodium from prescriptions that was previously communicated. Calcium concentration is below manufacturing specification.
- 2021-01-20FDA-DeviceFresenius Medical Care Holdings, Inc.Class IINaturalyte Liquid Acid concentrate bottles, Product Code 08-2301-3 - Product Usage: used in conjunction with Fresenius Renal Technologies Sodium Bicarbonate Concentrate in a compatible 45X dilution three-stream artificial kidney (hemodialysis) machine.
The deviation in conductivity for sodium level exceeds 0.6mS/cm from the theoretical conductivity (TCD) or approximately 6mEq/L of sodium from prescriptions that was previously communicated. Calcium concentration is below manufacturing specification.
- 2021-01-20FDA-DeviceFresenius Medical Care Holdings, Inc.Class IICitrasate Liquid Acid concentrate bottles, Product Code 08-2251-CA - Product Usage: used in conjunction with Fresenius Renal Technologies Sodium Bicarbonate Concentrate in a compatible 45X dilution three-stream artificial kidney (hemodialysis) machine.
The deviation in conductivity for sodium level exceeds 0.6mS/cm from the theoretical conductivity (TCD) or approximately 6mEq/L of sodium from prescriptions that was previously communicated. Calcium concentration is below manufacturing specification.
- 2021-01-20FDA-DeviceFresenius Medical Care Holdings, Inc.Class IINaturalyte Liquid Acid concentrate bottles, Product Code 08-2251-0 - Product Usage: used in conjunction with Fresenius Renal Technologies Sodium Bicarbonate Concentrate in a compatible 45X dilution three-stream artificial kidney (hemodialysis) machine.
The deviation in conductivity for sodium level exceeds 0.6mS/cm from the theoretical conductivity (TCD) or approximately 6mEq/L of sodium from prescriptions that was previously communicated. Calcium concentration is below manufacturing specification.
- 2021-01-20FDA-DeviceFresenius Medical Care Holdings, Inc.Class IINaturalyte Liquid Acid concentrate bottles, Product Code 08-2201-5 - Product Usage: used in conjunction with Fresenius Renal Technologies Sodium Bicarbonate Concentrate in a compatible 45X dilution three-stream artificial kidney (hemodialysis) machine.
The deviation in conductivity for sodium level exceeds 0.6mS/cm from the theoretical conductivity (TCD) or approximately 6mEq/L of sodium from prescriptions that was previously communicated. Calcium concentration is below manufacturing specification.
- 2021-01-20FDA-DeviceFresenius Medical Care Holdings, Inc.Class IINaturalyte Liquid Acid concentrate bottles, Product Code 08-1251-1 - Product Usage: used in conjunction with Fresenius Renal Technologies Sodium Bicarbonate Concentrate in a compatible 45X dilution three-stream artificial kidney (hemodialysis) machine.
The deviation in conductivity for sodium level exceeds 0.6mS/cm from the theoretical conductivity (TCD) or approximately 6mEq/L of sodium from prescriptions that was previously communicated. Calcium concentration is below manufacturing specification.
- 2021-01-20FDA-DeviceFresenius Medical Care Holdings, Inc.Class IICitrasate Liquid Acid concentrate drums, Model Number 13-3251-CA - Product Usage: used in conjunction with Fresenius Renal Technologies Sodium Bicarbonate Concentrate in a compatible 45X dilution three-stream artificial kidney (hemodialysis) machine.
The sodium and/or calcium levels in these concentrates were below the manufacturing specifications.
- 2021-01-20FDA-DeviceFresenius Medical Care Holdings, Inc.Class IICitrasate Liquid Acid concentrate drums, Model Number 13-2251-CA - Product Usage: used in conjunction with Fresenius Renal Technologies Sodium Bicarbonate Concentrate in a compatible 45X dilution three-stream artificial kidney (hemodialysis) machine.
The sodium and/or calcium levels in these concentrates were below the manufacturing specifications.
- 2021-01-20FDA-DeviceFresenius Medical Care Holdings, Inc.Class IICitrasate Liquid Acid concentrate bottles, Model Number 08-3251-CA - Product Usage: used in conjunction with Fresenius Renal Technologies Sodium Bicarbonate Concentrate in a compatible 45X dilution three-stream artificial kidney (hemodialysis) machine.
The sodium and/or calcium levels in these concentrates were below the manufacturing specifications.
- 2021-01-20FDA-DeviceFresenius Medical Care Holdings, Inc.Class IINaturaLyte Liquid Acid concentrate drums, Model Number 13-3251-9 - Product Usage: used in conjunction with Fresenius Renal Technologies Sodium Bicarbonate Concentrate in a compatible 45X dilution three-stream artificial kidney (hemodialysis) machine.
The sodium and/or calcium levels in these concentrates were below the manufacturing specifications.
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