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.
- 2018-04-18FDA-DeviceC.R. Bard, Inc.Class IIBard(R) Premature Infant Feeding Tube, ENFit(TM), REF EN0036400 Product Usage: BARD(R) Nasogastric Sump Tubes with ENFit(TM) connector are intended to be used for: Decompression of stomach by suction or aspiration of gastric contents Short-term administration of term tube feeding, lavage fluid and medications Feeding Tubes with the ENFit(TM) Connector are made of a smooth plastic with a two-eyed tube used for nasogastric feeding of neonates, infants and adults as well as diagnostic and
BMD has identified that the product code/lot number combination identified above may have ineffectively fused tubing and ENFit(TM) connector.
- 2018-04-18FDA-DeviceCertified Safety Mfg IncClass IIFirst aid/emergency kits containing Honeywell eyewash: CSM kit number Kit/cabinet Description CSM Eyewash# Size: Honeywell Part# K206125 LXXV - 75V " Economy Cabinet 3 Shelf R508016 Eye Wash " 4 oz. 32-000452-0000 K 206154 LXXV - 75V " Deluxe Cabinet ¿3 Shelf RS08016 Eye Wash - 4 oz. 32-000452-0000 K206210 FAC- 3 ¿Deluxe Cabinet ¿3 Shelf R508016 Eye Wash - 4 oz. 32-000452-0000 K606999 ZLB¿CSX CPR Kit 37 R508016 Eye Wash " 4 oz. 32-000452-0000 KR206152 FAC " 4R ¿200 Person Deluxe Cabine
Firm is recalling first aid/emergency kits and cabinets which contain Honeywell Eyewash (3 lots) which is being recalled due to leaking bottles.
- 2018-04-17NHTSA-EquipmentHarmony Juvenile ProductsHarmony Juvenile Products — Booster Seat Excessive Force/FMVSS 213
Excessive chest force can increase the risk of injury.
- 2018-04-11FDA-DeviceDynavox Systems LlcClass IIDynavox T15 Speech Generating Device ( including Batteries)
The battery is integral to the device. If the device sits unused and is not charged for a lengthy period of time (a few months) the battery will go into a deep discharge state and the battery will expire. The battery may out-gas which may be described as swelled or puffed, as gas is trapped inside the pack surrounding the cells. This battery may cause the device case to separate a small amount.
- 2018-04-11FDA-DeviceDynavox Systems LlcClass IIDynavox T10 Speech Generating Device ( including Batteries)
The battery is integral to the device. If the device sits unused and is not charged for a lengthy period of time (a few months) the battery will go into a deep discharge state and the battery will expire. The battery may out-gas which may be described as swelled or puffed, as gas is trapped inside the pack surrounding the cells. This battery may cause the device case to separate a small amount.
- 2018-04-11FDA-DeviceThe Binding Site Group, Ltd.Class IIBinding Site Optilite Beta-2-Microglobulin Urine Kit, Ref LK043.L.OPT.A, IVD. The firm name on the label is The Binding Site Group Ltd., Birmingham, U.K. The Optilite Beta-2-Microglobulin (¿2M) Urine kit is intended for the quantitative in-vitro measurement of beta-2-microglobulin in urine using the Binding Site Optilite analyser to aid in the diagnosis of active rheumatoid arthritis and kidney disease. This test should be used in conjunction with other laboratory and clinical findings.
The product is not meeting the antigen excess protection claim of up to 760mg/L, as stated in the Instructions for Use.
- 2018-04-11FDA-DeviceAesculap Implant Systems LLCClass IIDS Titanium Ligation Clip, used in laparoscopic surgery
Added a contraindication to IFU: Do not use the DS clips for living donor nephrectomies. Added other contraindications. A publication from 2017 recommended Aesculap DS Clips for kidney transplantation with living donors. The information from this publication was not approved or validated by the firm.
- 2018-04-04FDA-DeviceConMed CorporationClass IIMINI INFANT < 3KG, RADIOTRANSLUCENT ELECTRODE, ZOLL¿ Connector, REF/Catalog Number 2602Z Indicated for use in external pacing, defibrillation and monitoring applications as a non-sterile, disposable device for single pediatric use, only. The PadPro 2602 electrodes provide the conductive interface between the defibrillator and/or the external transcutaneous (non-invasive) cardiac pacemaker and the pediatric patients skin. The electrode is intended for use on pediatric infants whose weight is
Wire sets of certain devices were assembled with adhesive on the contact wires, which may impede conductivity and could cause failure
- 2018-04-04FDA-DeviceConMed CorporationClass IIMINI INFANT < 3KG, RADIOTRANSLUCENT ELECTRODE, Physio-Control¿ Quik-Combo" Connector, REF/Catalog Number 2602M Indicated for use in external pacing, defibrillation and monitoring applications as a non-sterile, disposable device for single pediatric use, only. The PadPro 2602 electrodes provide the conductive interface between the defibrillator and/or the external transcutaneous (non-invasive) cardiac pacemaker and the pediatric patients skin. The electrode is intended for use on pediatric in
Wire sets of certain devices were assembled with adhesive on the contact wires, which may impede conductivity and could cause failure
- 2018-04-04FDA-DeviceConMed CorporationClass IIMINI INFANT < 3KG, RADIOTRANSLUCENT ELECTRODE, Philips Plug Style Connector, REF/Catalog Number 2602H Indicated for use in external pacing, defibrillation and monitoring applications as a non-sterile, disposable device for single pediatric use, only. The PadPro 2602 electrodes provide the conductive interface between the defibrillator and/or the external transcutaneous (non-invasive) cardiac pacemaker and the pediatric patients skin. The electrode is intended for use on pediatric infants who
Wire sets of certain devices were assembled with adhesive on the contact wires, which may impede conductivity and could cause failure
- 2018-04-04FDA-DeviceConMed CorporationClass IIMINI INFANT < 3KG, RADIOTRANSLUCENT ELECTRODE, Philips Plug Style Connector, REF/Catalog Number 2602H Indicated for use in external pacing, defibrillation and monitoring applications as a non-sterile, disposable device for single pediatric use, only. The PadPro 2602 electrodes provide the conductive interface between the defibrillator and/or the external transcutaneous (non-invasive) cardiac pacemaker and the pediatric patients skin. The electrode is intended for use on pediatric infants who
Wire sets of certain devices were assembled with adhesive on the contact wires, which may impede conductivity and could cause failure
- 2018-04-04FDA-DeviceConMed CorporationClass IIMINI INFANT < 3KG, RADIOTRANSLUCENT ELECTRODE, Universal/Anderson Connector, REF/Catalog Number 2602 Indicated for use in external pacing, defibrillation and monitoring applications as a non-sterile, disposable device for single pediatric use, only. The PadPro 2602 electrodes provide the conductive interface between the defibrillator and/or the external transcutaneous (non-invasive) cardiac pacemaker and the pediatric patients skin. The electrode is intended for use on pediatric infants whose
Wire sets of certain devices were assembled with adhesive on the contact wires, which may impede conductivity and could cause failure
- 2018-04-04FDA-FoodIDLife, LLCClass IIIDLife Kids Bar Chocolate and Mixed Berry (SKU 16-0013) Organic, non-GMO, gluten-free and nut-free snack bar for children. Individually wrapped bars, packaged 10 to a box
IDLife Kids Bar is labeled as nut free. Allergen testing indicated the presence of almonds and coconut.
- 2018-04-04FDA-FoodMondelez Global LlcClass IISour Patch Kids, 1.9 lb bag
Mondelez Global LLC is initiating a recall because remnants of a half peanut shell were found in two containers of bulk candy from a single lot during the repacking process and the candy is not labeled as containing peanuts. Mondelez Global LLC after an investigation, including inspection of product within in their control from the same lot did not find any other evidence of peanut contamination. The firm believes this is most likely to be an isolated incident and that product on the market is unlikely to contain any peanut pieces and the product is not likely to cause adverse health consequences to peanut allergic consumers. No adverse health events have been reported. Never the less, out of an abundance of caution, we have determined to conduct a voluntary recall to the retail level.
- 2018-03-28FDA-DeviceMerit Medical Systems, Inc.Class IICustom Dialysis Kit CF-4230 Without Gel, which includes Flex-Neck¿ Classic Peritoneal Dialysis Catheter 2 Cuffs Infant Coiled, Catalog # K14-00078
1 Cuff catheters were incorrectly configured and labeled as 2 Cuff product and placed into these dialysis kits.
- 2018-03-28FDA-DeviceMerit Medical Systems, Inc.Class IICustom Dialysis Kit CF-4235 Without Gel, which includes Flex-Neck¿ Classic Peritoneal Dialysis Catheter 1 Cuff Infant Coiled, Catalog # K14-00079
2 Cuff catheters were incorrectly configured and labeled as 1 Cuff product and placed into these dialysis kits.
- 2018-03-28FDA-DeviceMerit Medical Systems, Inc.Class IIFlex-Neck Classic Peritoneal Dialysis Catheter 1 Cuff Infant Coiled, Catalog # CF-4235/B
2 Cuff catheters were incorrectly configured and labeled as 1 Cuff product.
- 2018-03-28FDA-DeviceNxStage Medical, Inc.Class IINxStage PureFlow B Solution - Premixed Dialysate for Hemodialysis with NxStage System One
Using different fluid formulations of NxStage PureFlow B Solution at the same time during treatment may cause patient health risk. The NxStage PureFlow B Solution is for use with systems that use one premixed dialysate during hemodialysis. The original labeling did not warn against mixing dialysate formulations and did not instruct staff to verify that the fluid is flowing during use.
- 2018-03-28FDA-DeviceCenturion Medical Products CorporationClass IIINFANT IV SECUREMENT KIT
Convenience Kit containing components to assist practitioner with IV placement and securement.
- 2018-03-28FDA-FoodFood and Beverage Inc.Class IIName: Trader Joe s Chocolate Chip Cookies SKU 68075 Net Weight: 12 oz. (340g) Number of units per package: 16 cookies Package type: Kraft paper bag
Food & Beverage Inc., dba Chris's Cookies has initiated a recall of Trader Joe s Peanut Butter Sutter s Formula Cookies (Trader Joes SKU 93307) that was packed in a Trader Joes branded Chocolate Chip Cookie bag, and sent out as Chocolate Chip Cookies. Please note the Chocolate Chip Cookie bag has a statement on the back that says: MAY CONTAIN TRACES OF PEANUTS AND TREE NUTS , but since the wrong product packed is based almost completely in peanut this could represent a bigger risk for those who have peanuts allergies. Thus, prompting the firm to error on the side of public safety and initiate a recall.
- 2018-03-21FDA-DeviceFresenius Medical Care Renal Therapies Group, LLCClass IINaturaLyte¿ Liquid Acid Concentrate 2.0 mEq/L, Model # 08-2251-0 3.43 liter bottle This concentrate is formulated to be used in conjunction with Fresenius Renal Technologies Sodium Bicarbonate Concentrate in a compatible 45X dilution three-stream artificial kidney (hemodialysis) machine.
The label specifies the potassium concentration is 2.0 mEq/L. Some of the product in the affected lot was found to have a potassium concentration of 2.25 mEq/L.
- 2018-03-21FDA-DeviceLaerdal Medical CorporationClass IILCSU 4, Laerdal Compact Suction Unit The LCSU 4 is a portable, electrically powered, medical suction device intended for field and transport use. It is intended for intermittent operation to remove secretions, blood or vomit from a patient s airway to allow ventilation. Higher vacuum levels are generally selected for oropharyngeal suction, and lower vacuum levels are usually selected for tracheal suctioning and the suctioning of children and infants.
A shipment of LCSU 4 suction units and canisters attempted importation into the United States but was refused by FDA for lack of necessary approvals with CDRH by the foreign firms.
- 2018-03-21FDA-DeviceMedimop Medical Projects Ltd.Class IIVial2BagDC, Product Number 6070112. The 20mm Vial2Bag DC device, is intended for use in healthcare facilities or in-home environment by the patient or care-giver to aid and support prescribed treatment and therapy. The device consists of the Vial2Bag piercing spike and cover, the IV Port connector and an integrated Vial Adapter (20mm) for access to the drug/solution vial.
Medimop is recalling certain lots of this product Vial2Bag DC due to the potential of the IV Port separating from the Via12Bag DC body during the drug reconstitution I IV Set attachment process.
- 2018-03-21FDA-DeviceCook Inc.Class IIFemoral Artery Pressure Monitoring Set
Label does not state that the product is heparin-coated.
- 2018-03-21FDA-DrugPfizer Inc.Class IHydromorphone, Hydrochloride, Injection, USP CII, 10 mg/mL, Rx Only, 1 mL Single-dose Vial, High Potency Formulation. Hospira, Inc., Lake forest, IL 60045 USA. NDC: 0409-2634-01
Non-Sterility: Confirmed customer complaints of glass product container vials that may be empty or cracked.
- 2018-03-21FDA-DrugPfizer Inc.Class IHydromorphone, Hydrochloride, Injection, USP CII, 10 mg/mL, Rx Only, 1 mL Single-dose Vial, High Potency Formulation. Mfd For: Teva Parenteral Medicines, Inc., Irvine, CA 92618. NDC: 0703-0110-01
Non-Sterility: Confirmed customer complaints of glass product container vials that may be empty or cracked.
- 2018-03-21CPSCFyrnetics Limited, of Hong KongKidde Recalls Dual Sensor Smoke Alarms Due to Risk of Failure to Alert Consumers to a Fire
A yellow cap left on during the manufacturing process can cover one of the two smoke sensors and compromise the smoke alarm's ability to detect smoke, posing a risk of consumers not being alerted to a fire in their home.
- 2018-03-16USDAClass IDon't eat recalled Stampede Meat beef steaks
Product Contamination
- 2018-03-15CPSCYangzhou Rich Arts & Crafts Co., Ltd., of Yang Zhou City, ChinaHandi-Craft Recalls Dr. Brown's Lovey Pacifier & Teether Holders Due to Choking Hazard
The snap can detach from the pacifier's ribbon, posing a choking hazard for young children.
- 2018-03-15USDAClass IDon't eat Standard Meat Company sirloin steaks
Product Contamination
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