Baby and kids' product recalls
6675 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.
- 2013-11-20FDA-FoodUltra LaboratoriesClass IIDigestive Health, 90 vegetable capsules
Ultra Laboratories is recalling Digestive Health because a raw material used in its formulation may have been contaminated with chloramphenicol.
- 2013-11-20FDA-FoodCreation's Garden Natural Products IncClass IIWELLTRIENTS DIGESTAIDS FORMULA #2, 90 capsules per bottle. Item #61256-90
Creation's Garden Natural Products (CGNP) is recalling Welltrients Digestaids Formula #2 because it has been found to contain chloramphenicol.
- 2013-11-15CPSCThe Step2® Company, LLC of Streetsboro, OhioStep2 Recalls Ride-On Wagon Toys Due to Fall Hazard; Sold Exclusively at Toys R Us
The removable blue seat backs can detach and allow the child in the wagon to fall out, posing a fall hazard.
- 2013-11-13FDA-DeviceHamilton Medical, Inc.Class IIHAMILTON-C2 Ventilator: Manufactured by Hamilton Medical AG CH-7402 Bonaduz, Switzerland; Imported and distributed by Hamilton Medical, Inc. Reno, NV 89502 The HAMILTON C2 ventilator is intended to provide positive pressure ventilatory support to adults, pediatrics, infants and neonates depending on its configuration. Intended areas of use: In the intensive care ward or in the recovery room; During transfer of ventilated patients within the hospital.
Manufacturer defined limits for improperly functioning loudspeakers of the HAMILTON C2 alarm system were exceeded.
- 2013-11-13FDA-FoodIrwin NaturalsClass IIDual Action Cleanse by Cellular Research Formulas with Green Tea Bonus 60 ct, Item AN056906E, UPC Code: 7 10363 56906 8
Irwin Naturals is recalling Daily Digestive Enzymes and Dual Action Cleanse because they may possibly be contaminated with chloramphenicol.
- 2013-11-13FDA-FoodIrwin NaturalsClass IIDual Action Cleanse by Cellular Research Formulas, 60 ct, Item AN027370, UPC 7 10363 27370 5, Item AN056592HFS, UPC 7 10363 56592 3; Item DR056439, UPC 7 10363 57369 0.
Irwin Naturals is recalling Daily Digestive Enzymes and Dual Action Cleanse because they may possibly be contaminated with chloramphenicol.
- 2013-11-13FDA-DrugWest-Ward Pharmaceutical Corp.Class IIIrinotecan Hydrochloride Injection, 100 mg/5 mL (20 mg/mL), 1 x 5 mL Single Dose Vial per carton, Rx only, Manufactured by: Thymoorgan Pharmazie GmbH, Schiffgraben 23, 38690 Vienenburg, Germany; Distributed by: West-Ward Pharmaceutical Corp., Eatontown, NJ 07724 USA, NDC 0143-9701-01.
Superpotent Drug: a recent review of the USP revealed that an incorrect calculation was used to determine the amount of irinotecan to use in formulation which will result in an assay higher than the labeled claim.
- 2013-11-13FDA-DrugWest-Ward Pharmaceutical Corp.Class IIIrinotecan Hydrochloride Injection, 40 mg/2 mL (20 mg/mL), 1 x 2 mL Single Dose Vial per carton, Rx only, Manufactured by: Thymoorgan Pharmazie GmbH, Schiffgraben 23, 38690 Vienenburg, Germany; Distributed by: West-Ward Pharmaceutical Corp., Eatontown, NJ 07724 USA, NDC 0143-9702-01.
Superpotent Drug: a recent review of the USP revealed that an incorrect calculation was used to determine the amount of irinotecan to use in formulation which will result in an assay higher than the labeled claim.
- 2013-11-13CPSCDream on Me Inc., of South Plainfield, N.J.Dream On Me Recalls Cradle Gliders Due to Infant Fall Hazard
The mattress support board can fall out or slide out of the bottom of the cradle glider posing a risk that babies can fall out and suffer injuries.
- 2013-11-12CPSCBabycottons, of Miami, Fla.Children's Pajamas Recalled by Babycottons Due to Violation of Federal Flammability Standard
The nightgowns fail to meet federal flammability standards for children's sleepwear, posing a risk of burn injuries to children.
- 2013-11-12CPSCL.L. Bean Inc., of Freeport, MaineL.L. Bean Girl's Pajamas Recalled Due to Violation of Federal Flammability Standard
The pajama sets fail to meet the federal flammability standard for children's sleepwear, posing a risk of burn injuries to children.
- 2013-11-12CPSCWood Castle Furniture, of Albany, Ore.Wood Castle Furniture Recalls Bunk Beds Due to Entrapment Hazard
The openings between the guardrails on the bunk bed can exceed 3 ½ inches in width, which is too wide and does not meet safety standards. This presents an entrapment hazard where a child could be seriously injured or become asphyxiated.
- 2013-11-07CPSCVans Inc., of Cypress, Calif.Vans Recalls Boy's Hooded Jackets with Drawstrings Due to Strangulation Hazard
The jackets have drawstrings in the hood around the neck area that pose a strangulation hazard to young children.
- 2013-11-06FDA-DeviceStryker Instruments Div. of Stryker CorporationClass IIREF 5100-088, TPS Micro Driver, For Use with Stryker Total Performance System Caution Federal Law (USA) restricts the device to use by or on the order of a physician Driver, Wire and Bone Drill; The Stryker Total Performance System (TPS) is intended for use in the cutting, drilling, reaming, decorticating and smoothing of bone and other bone related tissues for a variety of applications such as ENT, dental, orthopedic, maxillofacial, spinal, and plastic surgery. The instruments are also u
It was discovered that the silicone potting failed to properly cure after undergoing the prescribed curing possess. The potting material is used to insulate, stabilize and provide a moisture barrier to the TPS MicroDriver main Printed Circuit Board Assembly (PCBA). Inadequate cure of the silicone potting could potentially allow it to leak to the outside of the handpiece or cause an electrical ma
- 2013-10-30FDA-DeviceAlere San Diego, Inc.Class IIIAlere Triage¿ TOX Drug Screen Control 1 Product Generic Name: Quality Control Material Description of the product: Good Laboratory Practice suggests that external controls should be tested with each new lot or shipment of test materials, or every 30 days, and as otherwise required by a laboratorys standard quality control procedures. The Alere Triage¿ Drug Screen Controls, when used in accordance with the test procedures described in the Alere Triage¿ TOX Drug Screen package insert, p
Alere San Diego, Inc. initiated a voluntary recall of Alere Triage TOX Drug Screen Control 1 (PN 94413, Lot C2681A) because the CODE CHIP that was provided with this lot causes the control to fail when run in the QC Sample Mode using Alere Triage TOX Drug Screeen products. The Alere Triage TOX Drug Screen test devices and patient results are not affected.
- 2013-10-30FDA-FoodVinco Inc.Class IIVinco's Fem-Vite Women's Anti-Oxidant Formula, Dietary Supplement, 60 Tablets, distributed by Vinco, Inc., Evans City, PA
The soy ingredient used to manufacture certain lots of Vinco's Fem-Vite was potentially contaminated with Salmonella.
- 2013-10-29CPSCBreathableBaby LLC, of Minnetonka, Minn.BreathableBaby Recalls Wearable Blanket Due to Choking Hazard
The zipper pull tabs and sliders can detach posing a choking hazard to infants.
- 2013-10-29CPSCL. Powell Acquisition Corporation, of Culver City, Calif.Target Recalls Children's Sitting Stools Due to Fall Hazard
The stabilizing bar can crack and cause the stool to collapse, posing a fall hazard to the user.
- 2013-10-23FDA-DrugMcneil Consumer Healthcare, Div Of Mcneil-ppc, Inc.Class IIConcentrated Motrin (ibuprofen) Infants' Drops Oral Suspension, Original Berry Flavor 1/2 fl oz bottles, 50 mg per 1.25ml, Distributed by McNeil Consumer Healthcare, Fort Washington, PA.
Presence of Foreign Substance: process-related particulates which may be associated with the raw materials were observed
- 2013-10-23CPSCInfinitoy, Inc., San Mateo, Calif.Infinitoy Recalls Softimals Toy Sets Due to Choking and Aspiration Hazard
The plastic hats found on playset figures pose a choking/aspiration hazard for children.
- 2013-10-23NHTSA-EquipmentOrbit Baby, Inc.Orbit Baby, Inc. — Child Seat Base/StrongArm Knob/Detaches or Spins
If the seat base is not properly secured, a child may be at an increased risk of injury in the event of a crash.
- 2013-10-22CPSCTrail Crest, Brooklyn, N.Y.Trail Crest Recalls Children's Hooded Sweatshirts Due to Strangulation Hazard
The hoodies and jackets have drawstrings through the hood or neck which pose a strangulation hazard to young children.
- 2013-10-02FDA-DeviceHoriba Instruments, Inc dba Horiba MedicalClass IIIABX PENTRA Calcium CP Reagent, Model # A11A01633 Calcium plays an essential role in many cell functions: intracellularly in muscle contraction and glycogen metabolism, extracellularly, in bone mineralization, in blood coagulation and in transmission of nerve impulses. Calcium is present in plasma in three forms: free, bound to proteins or complexed with anions as phosphate, citrate and bicarbonate. Under physiological conditions, calcium balance is determined by the relationship between calci
HORIBA Medical is informing all PENTRA 200 and PENTRA 400 customers of a potential for reporting incorrect calcium results when using the ABX PENTRA CALCIUM CP reagent.
- 2013-10-02FDA-FoodHealthmaxx Global Inc.Class IIIMAX Brand Kidney Strong, 120 Count Tablets Product labeling reads in part:"MAX KIDNEY STRONG***Dietary Supplement 120 Tablets***6 65176 13427 2***Manufactured for: HealthMax Products, Inc. Altadena, CA 91001***".
In response to a FDA inspection, the firm initiated this voluntary recall of various dietary supplements due to the following problems of mislabeling: 1) product named on the label is not actual product contained; 2)ingredients listed are not actual ingredients contained.
- 2013-10-02FDA-FoodHealthmaxx Global Inc.Class IIIDietary Supplements Under the Same Formulation, Labeled and Packaged as the Following: MAX Brand SOY ISOFLAVONES, 90 Count Capsules; MAX Brand ULTRA PROBIOTICS, 90 Count Capsules Product labeling reads in part:"MAX SOY ISOFLAVONES MENOPAUSE SUPPORT**DIETARY SUPPLEMENT 90 CAPSULES***6 65176 53126 2***Manufactured for:HealthMax Products Inc. Altadena, CA 91001***". Product labeling reads in part:"MAX ULTRA PROBIOTICS***90 Capsules Dietary Supplement***6 65176 30625 9***Manufactured in FDA
In response to a FDA inspection, the firm initiated this voluntary recall of various dietary supplements due to the following problems of mislabeling: 1) product named on the label is not actual product contained; 2)ingredients listed are not actual ingredients contained.
- 2013-10-02FDA-FoodHealthmaxx Global Inc.Class IIIDietary Supplements Under the Same Formulation, Labeled and Packaged as the following: MAX LUNG AID, 100 Count Capsules; MAX Brand POMEGRANATE, 100 Count Capsules. Product labeling reads in part:"MAX LUNG AID Extra Strength Dietary Supplement 100 CAPSULES***0 65176 26289 8***HealthMax Products Inc. Altadena, CA 91001***". Product labeling reads in part:"MAX POMEGRANATE DIETARY SUPPLEMENT 100 CAPSULES***0 65176 30266 2***Manufactured in FDA Approved Facility For:HealthMax Products Co. Alt
In response to a FDA inspection, the firm initiated this voluntary recall of various dietary supplements due to the following problems of mislabeling: 1) product named on the label is not actual product contained; 2)ingredients listed are not actual ingredients contained.
- 2013-10-02FDA-FoodHealthmaxx Global Inc.Class IIIDietary Supplements Under the Same Formulation, Labeled and Packaged as the Following: LIVERAID, 200 Count Softgels; LIVER AID, 200 Count Softgels; MAX Brand LIVER STRONG, 200 Count Softgels. Product labeling reads in part:"LIVERAID***Dietary Supplement 200 Softgels***6 65176 82031 1***Manufactured in FDA Approved Facility For:HealthMax Products Co. Altadena, CA 91001***". Product labeling reads in part:"LIVER AID***DIETARY SUPPLEMENT 200 Softgels***6 65176 02434***Manufactured in FDA A
In response to a FDA inspection, the firm initiated this voluntary recall of various dietary supplements due to the following problems of mislabeling: 1) product named on the label is not actual product contained; 2)ingredients listed are not actual ingredients contained.
- 2013-10-02FDA-FoodHealthmaxx Global Inc.Class IIIDietary Supplements under the same formulation, Labeled and Packaged in the Following: MAX Brand Proste-Support, 150 Count Tablets. Product labeling reads in part:"Manufactured for: HealthMax Products Inc. Altadena, CA 91001***".
In response to a FDA inspection, the firm initiated this voluntary recall of various dietary supplements due to the following problems of mislabeling: 1) product named on the label is not actual product contained; 2)ingredients listed are not actual ingredients contained.
- 2013-09-19CPSCThe Land of Nod, of Morton Grove, Ill.The Land of Nod Recalls Bed Frames Due to Entrapment Hazard (Recall Alert)
The openings in the headboard and footboard pose an entrapment hazard to young children.
- 2013-09-18FDA-DeviceSybron Dental SpecialtiesClass IIAOA Mini RPE Screw Assembly , a component of Herbst, MARA and Fixed Metal devices. Product Usage: AOA Mini RPE Screw Assembly is a component of Herbst, MARA and Fixed Metal devices; removable functional appliances that are to modify the growth of the jaws in a prescribed growth pattern, however, this category is generally attached to the patients upper and lower molars or bicuspids by means of temporary stainless steel crowns or orthodontic bands. Retainer, Screw Expansion, Orthodontic.
The firm initiated the recall of AOA Mini RPE Screw Assembly, because it may be missing a complete weld joining one side of the arm with the screw body. Herbst, MARA and Fixed Metal devices may be affected, because they contain an AOA Mini RPE Screw Assembly.
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