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.
- 2022-06-15FDA-DrugUS Specialty Formulations LLCClass IIB-Complex + Chromic Chloride (Choline Chloride 3%, Inositol 3%, Pyridoxine HCl 2%, Niacinamide 2%, Thiamine HCl 2%, Chlorobutanol 0.5%, Riboflavin 0.05%, Chromic Chloride 0.003%), 30 mL Multi-Dose Vial, packaged in 2 x 30 mL Multi-Dose Vials per carton, US Specialty Formulations, LLC, 116 Research Drive, Bethlehem, PA 18015, P/N: 234-15523
Lack of Assurance of Sterility
- 2022-06-15FDA-DrugUS Specialty Formulations LLCClass IIEthanol for Injection 95%, 67 mL Multi-Dose vial, Rx only, US Specialty Formulations, 1403 South Albert Street, Allentown, PA 18103, PN: 69389-06229
Lack of Assurance of Sterility
- 2022-06-09CPSCJungleJump LLC, dba Jungle Jumparoo, of American Fork, UtahJungle Jumparoo Recalls Children's Toys Due to Violation of the Federal Lead Content Ban (Recall Alert)
The toys' yellow poles contain levels of lead that exceed the federal lead content ban. Lead is toxic if ingested by young children and can cause adverse health issues.
- 2022-06-09CPSCThe Manhattan Toy Company, of Minneapolis, Minn.The Manhattan Toy Company Recalls Activity Loops Toys for Infants Due to Choking Hazard
Tubes on the Activity Loops toys can detach from the base releasing small plastic rings, posing a small parts choking hazard to children.
- 2022-06-08FDA-DeviceIon Beam Applications S.A.Class IIProteus235- Proton Therapy System: to produce and deliver a proton beam for the treatment of patients with localized tumors and other conditions susceptible to treatment by radiation
First layer of Uniform Scanning treatment fields is sometimes irradiated with incorrect Scanning Magnet setpoints resulting in the field size may be smaller than expected and the irradiated area may receive more dose than prescribed
- 2022-06-08FDA-DrugFamily Dollar Stores, Llc.Class IILuxury Hygiene Hand Sanitizer Moisturizing Formula with Vitamin E, 8 FL. OZ. (236 mL), TSM Brands LLC 540 Equinox Ln Manalapan, NJ 07726, UPC 6 86275 96536 9
cGMP deviations: product stored outside of labeled temperature requirements.
- 2022-06-08FDA-DrugFamily Dollar Stores, Llc.Class IILuxury Hygiene Hand Sanitizer Moisturizing Formula with Vitamin E Advanced Aloe Vera, 8 FL. OZ. (236 mL), TSM Brands LLC 540 Equinox Ln Manalapan, NJ 07726, UPC 6 86275 96537 6
cGMP deviations: product stored outside of labeled temperature requirements.
- 2022-06-07NHTSA-EquipmentClek, Inc.Clek, Inc. — Installation Diagram Missing/FMVSS 213
A missing installation label may result in an improperly installed child seat, increasing the risk of injury in a crash.
- 2022-06-02CPSCAsweets Global Inc., City of Industry, CaliforniaAsweets Recalls Wood Baby Activity Push Walkers Due to Strangulation Hazard
Rubber rings on the rear wheels can separate from the wheels and detach from the Activity Walkers, posing a strangulation hazard to young children.
- 2022-06-02CPSCJoey Clothing Inc., of Moonachie, New JerseyJoey Clothing Recalls Children's Robes Due to Burn Hazard
The children's robes fail to meet flammability standards for children's sleepwear, posing a risk of burn injuries to children.
- 2022-06-02CPSCTarget Corporation, of Minneapolis, MinnesotaTarget Recalls Children's Cat & Jack Unicorn Cozy Pajama Sets Due to Burn Hazard
The children's pajama sets fail to meet the federal flammability standards for children's sleepwear, posing a risk of burn injuries to children.
- 2022-06-02CPSCCommunicorp Inc., of Columbus, GeorgiaCommunicorp Recalls Aflac Plush Promotional Ducks Due to Violations of Federal Phthalates and Lead Content Bans; Risk of Phthalates Exposure and Lead Poisoning Hazard
Components of the recalled promotional ducks contain levels of certain phthalates that exceed the federal phthalate content standard. A component of the promotional fishing duck also contains a level of lead that exceeds the federal lead content standard. Phthalates and lead are toxic if ingested by young children and can cause adverse health issues.
- 2022-06-01FDA-DeviceAccriva Diagnostics, Inc.Class IIThe VerifyNow P2Y12 Test is designed to measure platelet P2Y12 receptor blockade. Substances known to specifically block the P2Y12 receptor include ticagrelor and the thienopyridine class of drugs, including clopidogrel and prasugrel.1-8 The test is based upon the ability of activated platelets to bind fibrinogen. Fibrinogen-coated microparticles aggregate in whole blood in proportion to the number of expressed platelet GP IIb/IIIa receptors. Light transmittance increases as activated platelets
Two whole blood Platelet Reactivity tests exist that share the same reagent formulation and are used to obtain P2Y12 Reactivity Unit results. The test without US-FDA market clearance was distributed and it displays BASE results not displayed by the US-FDA market cleared device. A formula is being provided to health care personnel to calculate the percentage of platelet aggregation inhibition.
- 2022-06-01FDA-DrugOlympia Compounding Pharmacy dba Olympia PharmacyClass IIFormula F9 Papaverine 0.9 mg/mL Phentolamine 0.1 mg/mL PGE 20 mcg/mL Atropine 0.01 mg/mL, Multi-Dose 10 mL vial, Rx Only, Olympia Pharmaceuticals, 6700 Conroy Rd., Ste. 155 Orlando, FL 32835, NDC 73198-0004-10
Lack of assurance of sterility.
- 2022-06-01FDA-DrugOlympia Compounding Pharmacy dba Olympia PharmacyClass IIFormula F2 Papaverine 9 mg/mL Phentolamine 1 mg/mL Alprostadil 10 mcg/mL Atropine 0.1 mg/mL, Multi-Dose 10 mL vial, Rx Only, Olympia Pharmaceuticals, 6700 Conroy Rd., Ste. 155 Orlando, FL 32835, NDC 73198-0002-10
Lack of assurance of sterility.
- 2022-06-01FDA-DrugOlympia Compounding Pharmacy dba Olympia PharmacyClass IIFormula F1 Papaverine 1.8 mg/mL Phentolamine 0.2 mg/mL Alprostadil 18 mcg/mL Atropine 0.02 mg/mL, Packaged as a)2.5 mL Multi-Dose vial, NDC 73198-0001-03; b) 10 mL Multi-Dose vial, NDC 73198-0001-10; Rx Only, Olympia Pharmaceuticals, 6700 Conroy Rd., Ste. 155 Orlando, FL 32835
Lack of assurance of sterility.
- 2022-05-27USDAPublic Health AlertDo not eat Super Asian Chicken Salad
Product Contamination
- 2022-05-26CPSCFree Birdees LLC, of Culver City, CaliforniaFree Birdees Recalls Children's Pajamas Due to Burn Hazard (Recall Alert)
The children's pajamas fail to meet the federal flammability standards for children's sleepwear, posing a risk of burn injuries to children.
- 2022-05-26CPSCCopper Pearl Inc., of Salt Lake City, UtahCopper Pearl Recalls Children's Sleepwear Due to Violation of Federal Flammability Standards and Burn Hazard
The children's pajamas fail to meet the tight-fitting flammability standards for children's sleepwear, posing a risk of burn injuries to children.
- 2022-05-26CPSCAsweets Global Inc., City of Industry, CaliforniaAsweets Recalls Wonder & Wise Activity Tables Due to Choking Hazard
Screws can become loose and/or detach from the xylophone component of the activity tables, posing a choking hazard to young children.
- 2022-05-23NHTSA-EquipmentRed Rock LLCRed Rock LLC — Swing Up Table Could Drop Unexpectedly
A table that drops unexpectedly can increase the risk of injury.
- 2022-05-05CPSCBIBS Denmark ApS, of DenmarkBIBS Baby Bottles Recalled Due to Burn Hazard; Manufactured by BIBS Denmark ApS
Hot liquids in the bottle can cause the bumper to shrink, making the bottle tilt over spilling out contents, posing a burn hazard.
- 2022-05-05CPSCWinter Water Factory LLC, of Brooklyn, New YorkWinter Water Factory Recalls Infant French Terry Jumpsuits, Rompers, Snap Suits, Baby Dresses and Bibs Due to Choking and Laceration Hazards
The snaps on the recalled garments can detach and also expose small sharp prongs, posing choking and laceration hazards to young children.
- 2022-05-05CPSCNewCosplay, of ChinaChildren's Robes Recalled Due to Burn Hazard; Imported by NewCosplay
The children's robes fail to meet flammability standards for children's sleepwear, posing a risk of burn injuries to children.
- 2022-05-05CPSCLinum Home Textiles LLC, of Ridgefield, New JerseyLinum Home Textiles Recalls Children's Robes Due to Violation of Federal Flammability Standards and Burn Hazard
The children's robes fail to meet the federal flammability standards for children's sleepwear, posing a risk of burn injuries to children.
- 2022-05-04FDA-DeviceWaters Medical Systems LLCClass IIWAVES WCM Kidney Cassette Module
There is a potential for the WCM cassette pump head leaking solution.
- 2022-05-04FDA-DeviceBoston Scientific CorporationClass IISpaceOAR Vue System, UPN SV-1010 and SV-2101. Used to temporarily position the anterior rectal wall away from the prostate during radiotherapy for prostate cancer to reduce the radiation dose delivered to the anterior rectum.
Users need to be aware that embolism is a possible adverse event associated with hydrogel misplacements. Updated IFU provides new procedural instructions, warnings and precautions that describe steps to verify correct placement of the hydrogel following implantation, as well as technique recommendations for the proper placement of SpaceOAR and SpaceOAR Vue.
- 2022-05-04FDA-DeviceBoston Scientific CorporationClass IISpaceOAR System, UPN SO-1010, SO-2101, SO-3101, and SO-4101. Used to temporarily position the anterior rectal wall away from the prostate during radiotherapy for prostate cancer to reduce the radiation dose delivered to the anterior rectum.
Users need to be aware that embolism is a possible adverse event associated with hydrogel misplacements. Updated IFU provides new procedural instructions, warnings and precautions that describe steps to verify correct placement of the hydrogel following implantation, as well as technique recommendations for the proper placement of SpaceOAR and SpaceOAR Vue.
- 2022-05-04FDA-DrugOlympia Compounding Pharmacy dba Olympia PharmacyClass IIFormula F2, Papaverine 9 mg/mL . Phentolamine 1 mg/mL . Alprostadil 10 mcg/mL . Atropine 0.1 mg/mL, 10 mL Multi-Dose vial, Rx Only, Olympia Pharmaceuticals 6700 Convoy Rd., Ste. 155, Orlando, FL 32835. NDC 73198-0002-10.
CGMP Deviations: prior to October 1, 2021, environmental and personnel monitoring Out of Action Limit (OOAL) excursions were not being properly investigated
- 2022-05-04FDA-DrugOlympia Compounding Pharmacy dba Olympia PharmacyClass IIFormula F9, Papaverine 0.9mg/ml . Phentolamine 0.1mg/ml . PGE 20mcg/mL Atropine 0.01mg/ml, Multi-Dose 10 ml vial, Rx Only, Olympia Pharmaceuticals 6700 Convoy Rd., Ste. 155, Orlando, FL 32835. NDC: 73198-0004-10
CGMP Deviations: prior to October 1, 2021, environmental and personnel monitoring Out of Action Limit (OOAL) excursions were not being properly investigated
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