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.
- 2019-11-20CPSCChemisys International Pty Ltd, of AustraliaDeck Source Recalls Cutek Proclean Due to Violation of FHSA Labeling Requirements; Risk of Poisoning
The product contains the hazardous substance oxalic acid. The label on the product violates the Federal Hazardous Substance Act (FHSA) by omitting the word "poison" and printing the mandatory hazard statement for poisonous chemicals on the back of the label instead of the front, posing a risk of poisoning if swallowed by children.
- 2019-11-14CPSCQuest Products LLC, of Pleasant Prairie, Wis.Quest Products Recalls ALOCANE Emergency Burn Pads Due to Failure to Meet Child Resistant Closure Requirement; Risk of Poisoning
The packaging is not child resistant as required by the Poison Prevention Packaging Act. The pads contain lidocaine, posing a risk of poisoning to young children if they were to place the pad in their mouth.
- 2019-11-13FDA-DrugSato Pharmaceutical Inc.Class IIISankaijo BOTANICAL LAXATIVE (docusate sodium 8.33 mg and sennosides 1.36 mg) tablets, 150-count bottles, Manufactured by SATO PHARMACEUTICAL CO., LTD., 1-5-27 Motoakasaka Minato-KU Tokyo, Japan; SATO PHARMACEUTICAL, INC., 20695 S. Western Ave., Suite 240, Torrance, CA 90501; NDC 49873-404-01.
Subpotent Drug: Formulated amount of sennosides component is less than labelled claim.
- 2019-11-12CPSCHooey LLC, of Spring Branch, TexasHooey Recalls Children's Sweatshirts with Drawstrings Due to Strangulation Hazard
A drawstring in the sweatshirt hood poses a strangulation hazard to children. Drawstrings can become entangled or caught on playground slides, hand rails, school bus doors or other moving objects, posing a significant strangulation hazard to children.
- 2019-11-06FDA-DeviceOrthoPediatrics CorpClass IIModel No. 01-1501-0032 (Child Nail Attachment Bolt). Component of the Pediatric Nailing Platform. Product Usage: an orthopedic implant system commonly referred to as an intramedullary fixation rod (product code HSB). The attachment bolts are one component of the surgical instruments within the system.
Binding can occur between the attachment bolt and intramedullary nail, which may lead to delays in surgical procedures.
- 2019-11-06FDA-DrugTaro Pharmaceuticals U.S.A., Inc.Class IIChildren's Ibuprofen Oral Suspension USP, 100 mg per 5 mL, Berry Flavor, Dye-Free, Alcohol Free, 4 fl. oz.(120 mL), Distributed by: Winco Foods, LLC, Boise, ID 83704, NDC 67091-321-04
Presence of Foreign Substance: Ibuprofen Oral Suspension USP may have small particles of an inert plastic material introduced during manufacturing.
- 2019-11-06FDA-DrugTaro Pharmaceuticals U.S.A., Inc.Class IIChildren's Ibuprofen Oral Suspension USP, 100 mg per 5 mL, Berry Flavor, Dye-Free, Alcohol Free, 8 fl. oz.(240 mL), Distributed by: Taro Pharmaceuticals, U.S.A., Inc., Hawthorne, NY 10532, NDC 51672-2130-1
Presence of Foreign Substance: Ibuprofen Oral Suspension USP may have small particles of an inert plastic material introduced during manufacturing.
- 2019-11-06FDA-DrugTaro Pharmaceuticals U.S.A., Inc.Class IIChildren's Ibuprofen Oral Suspension USP, 100 mg per 5 mL, Berry Flavor, Dye-Free, Alcohol Free, 4 fl. oz. (120 mL), Distributed by: Taro Pharmaceuticals U.S.A., Inc., Hawthorne, NY 10532, NDC 51672-2130-8
Presence of Foreign Substance: Ibuprofen Oral Suspension USP may have small particles of an inert plastic material introduced during manufacturing.
- 2019-11-05NHTSA-EquipmentMerritt Manufacturing, Inc.Merritt Manufacturing, Inc. — Harness may not Restrain Child in a Crash
In the event of a crash, the harness may not restrain the bed occupant, increasing their risk of injury.
- 2019-10-31CPSCYi Hsin Lung Co. Ltd., of TaiwanNew Port Sales Recalls All-Gloo Craft Glue Due to Failure to Meet Child Resistant Closure Requirements; Poison Hazard to Children
The glue contains methanol and poses a poisoning hazard to young children if ingested. The packaging is not child-resistant as required by the Poisoning Prevention Packaging Act.
- 2019-10-30FDA-DeviceBaxter Healthcare CorporationClass IIEXACTAMIX Empty EVA (Ethylene Vinyl Acetate) TPN Bag with the following product code and sizes: 1. H938737, 250mL; 2. H938738, 500mL; 3. H938739, 1000mL; 4. H938740, 2000mL; 5. H938741, 3000mL Product Usage: The EXACTAMIX Empty EVA bags are used as the destination container in compounding of large-volume sterile solutions for further administration to a single patient. The empty bags are used at pharmacies and compounding centers by pharmacists and pharmacy technicians to
Potential ability to leak once used for compounding.
- 2019-10-30FDA-FoodVeritable VegetableClass IJayleaf Fresh Baby Spinach; 4 lb. box (1 x 4 lb. bag) and 12 lb. crate (3 x 4 lb. bags); Refrigerate
Notified by customer of presumptive positive results for Enterohemorrhagic E. coli (ECHEC)/Shiga Toxin-Producing E. coli (STEC) in fresh spinach.
- 2019-10-30FDA-FoodThreshold Enterprises LtdClass IIISource Naturals Dietary Supplement Brain Charge Advanced Cognitive Support 30 tablets, 60 tablets Manufactured for: Source Natural, Inc. PO Box 2118 Santa Cruz, CA 95062 Item Code: SN2613, SN2614 Item UPC: 021078026136, 021078026143
Labeling error; incorrect supplement facts panel and label claims for two ingredients were lower than the product formulation.
- 2019-10-18CPSCSoft Play LLC, of Huntersville, N.C.Soft Play Recalls Spider Climb Playground Climbers Due to Fall Hazard (Recall Alert)
The climbing level platforms were designed too far apart, posing a fall hazard to children who can fall climbing from one level to the next.
- 2019-10-18USDAClass IDo not use recalled Circle A or Clarks beef
Product Contamination
- 2019-10-17NHTSA-EquipmentDorel China America, Inc.Dorel China America, Inc. — Improper Warning Labels/FMVSS 213
Without the safety warnings and instructions, caregivers may not know the risks or how to properly use the child seat, increasing the risk of an injury in the event of a crash.
- 2019-10-16USDAPublic Health AlertDo not eat recalled raw beef products
Product Contamination
- 2019-10-16FDA-DeviceCenturion Medical Products CorporationClass IICenturion CIRCLAMP W/1.3 CM BELL-single-use, disposable instrument used to compress the foreskin of the penis during circumcision of a male infant. ReOrder: 330CR
A mismatch between the angle of the hole in the base and the angle of the bell, which may cause the clamp to remove foreskin without the use of a scalpel.
- 2019-10-16FDA-DeviceCenturion Medical Products CorporationClass IICenturion CIRCLAMP W/1.1CM BELL - single-use, disposable instrument used to compress the foreskin of the penis during circumcision of a male infant. ReOrder: 310CR
A mismatch between the angle of the hole in the base and the angle of the bell, which may cause the clamp to remove foreskin without the use of a scalpel.
- 2019-10-16FDA-DeviceOhmeda MedicalClass IIGiraffe Omnibed - Product Usage: The OmniBed is a combination of an infant incubator and an infant warmer. The device can be operated as an incubator or as a warmer and can transition from one mode to the other on user s demand. It cannot be operated in both modes at the same time. Incubators and warmers provide heat in a controlled manner to neonates who are unable to thermo-regulate based on their own physiology. Incubators provide an enclosed, temperature-controlled environment and warmers pr
GE Healthcare has become aware of a potential safety issue that can occur if the canopy seals are not cleaned appropriately. Healthcare professionals reported buildup of debris around the edge of the canopy seal which can lead to a source of infection. Upon review, the Agency concluded that the cleaning and care guidelines provided by the firm were inadequate for effective cleaning of the device. In particular, the instructions do not instruct for removal of canopy seal prior to cleaning, which leads to the buildup of debris.
- 2019-10-16FDA-FoodAbbott LaboratoriesClass IIAbbott Calcilo XD, Low-calcium Vitamin D-Free Infant formula with iron, powder in a 13.2 oz. can, with 6 cans per case.
Off color and odor. Compromised can seam due to product (powder) in the seam, this poor seal potentially allowed air into the container.
- 2019-10-16FDA-DrugUnipharma, Llc.Class IIDrKids Himasal Natural Nasal Saline Solution, packaged in Pre-measured Singe-Use Vials a) 0.5 mL Each (20 count) UPC 37030244608; b) 1.5 mL Each (20 count) UPC 370302446098, Manufactured in USA by: UNIPHARMA, LLC Tamarac, FL 33321
CGMP Deviations: Recall as a precautionary measure due to potential risk of product contamination with the bacteria B. cepacia.
- 2019-10-16FDA-DrugUnipharma, Llc.Class IIDrKids Children's Natural Cough Syrup English Ivy Leaf, packaged in Pre-measured Single-Use Vials 0.17 fl. oz. (5 mL) Each 3.4 fl. oz. (100 mL), Manufactured in USA by: UNIPHARMA, LLC Tamarac, FL 33321 UPC 370302489026
CGMP Deviations: Recall as a precautionary measure due to potential risk of product contamination with the bacteria B. cepacia.
- 2019-10-16FDA-DrugGCP Laboratories IncClass IIMajor Infants' Gas Relief Drops, Simethicone Oral Suspension USP, 1 FL OZ (30 mL) bottle, Distributed by: Major Pharmaceuticals 17177 N Laurel Park Drive, Suite 233 Livonia, MI 48152 USA. NDC 0904-5894-30
Microbial Contamination of Non-Sterile Product.
- 2019-10-09FDA-DeviceHowmedica Osteonics Corp.Class IITRIATHLON FEMORAL DISTAL AUGMENT 15MM - SIZE 2 LEFTTriathlon Femoral Distal Augments are used with Triathlon TS Femoral Components during revision Total Knee Arthroplasty (TKA) and with Triathlon Primary PS Femoral Components during TKA to address distal femoral defects. (See attached IFU (IFU_Triathlon Total Knee_QIN 4376 Rev AB) Catalog # 5542-A-201 - Product Usage:
Due to device overhang issue that protrudes beyond the medial periphery of the mating femoral component
- 2019-10-08CPSCIKEA Supply AG, of SwitzerlandIKEA Recalls Infant Bibs Due to Choking Hazard
The snap on the bibs can detach, posing a choking hazard to young children.
- 2019-10-03CPSCRidgewood Industries Inc., of CanadaRidgewood Recalls Four-Drawer Dressers Due to Tip-Over and Entrapment Hazards; Sold Exclusively at Kmart
The recalled dressers 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. Additionally, those models of dressers over 30 inches tall do not comply with the performance requirements of the U.S. voluntary industry standard (ASTM F2057-14).
- 2019-10-03CPSCE & E Co. Ltd., dba JLA Home, of Fremont, Calif.E&E Recalls Bedroom Dressers Due to Tip-Over and Entrapment Hazards
The recalled 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. The dressers do not comply with the performance requirements of the U.S. voluntary industry standard (ASTM 2057-17).
- 2019-10-02FDA-DevicePhilips North America LLCClass IIPhilips HeartStart Infant/Child SMART Pads Cartridge, Model # M5072A, UDI:00884838023758
The recall is being initiated due to incorrect age range labeling (8+ yrs) on the foil packaging for infant/child pad cartridges. The infant/child pad cartridge is designed for use with the defibrillator An Infant/Child pad cartridge should not be used on an adult because it delivers lower energy (50 J vs 150 J) than the Adult pads cartridge and may therefore not be effective on an adult.
- 2019-09-24CPSCHome Meridian International, of High Point, N.C.Home Meridian Recalls Three-Drawer Chests Due to Tip-Over and Entrapment Hazards
The recalled chests 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. The chests do not comply with the performance requirements of the U.S. voluntary industry standard (ASTM F2057-17).
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