Baby and kids' product recalls
6719 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.
- 2022-06-01FDA-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
- 2022-04-28CPSCBest Nutritionals LLC, of Piscataway, New JerseyBest Nutritionals Recalls Organic Wintergreen Essential Oil Due to Failure to Meet Child Resistant Packaging Requirements; Risk of Poisoning (Recall Alert)
The product contains 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.
- 2022-04-28CPSCBed Bath & Beyond, of Union, N.J.Bed Bath & Beyond Recalls Woven Bunny Baskets Due to Choking Hazard
The bunny basket's eyes can detach, posing a choking hazard to young children.
- 2022-04-27USDAPublic Health AlertThrow out ground beef products from December 2021
Product Contamination
- 2022-04-21CPSCMonti Kids Inc., of Orinda, CaliforniaMonti Kids Recalls Wooden Push Toys Due to Choking Hazard (Recall Alert)
The toy's rolling cylinder can separate, exposing the balls inside, posing a choking hazard to children.
- 2022-04-21CPSCThe Red League, of Brooklyn, New YorkThe Red League Recalls Children's Pajamas Due to Burn Hazard
The children's pajamas fail to meet the federal flammability standards for children's sleepwear, posing a risk of burn injuries to children.
- 2022-04-20FDA-DeviceStanbio Laboratory, LPClass IISeparation Technology Creamatocrit Plus, Catalog Number: 100-146
The device was being marketed as an IVD without a 510(k). Therefore, performance characteristics of these breast milk analyzers have not been adequately validated. An erroneous result could lead to sub-optimal nutrition supplementation for patients (infants)
- 2022-04-14CPSCTelebrands Corp., of Fairfield, N.J.Telebrands Recalls Hempvana Pain Relief Products with Lidocaine Due to Failure to Meet Child Resistant Packaging Requirement; Risk of Poisoning
The products contain the substance lidocaine 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 or placed on the skin of young children.
- 2022-04-14CPSCMerchSource LLC, of Irvine, CaliforniaMerchSource Recalls FAO Schwarz Branded Toy Wood Play Smart Robot Buddy(s) and Wood Sensory Boards Due to Choking Hazard
Due to a manufacturing issue, small parts from the products can come loose, posing a choking hazard to young children.
- 2022-04-14CPSCRae Wellness, of Minneapolis, Minn.Rae Wellness Recalls Prenatal and Immunity Dietary Supplements Due to Failure to Meet Child Resistant Packaging Requirement; Risk of Poisoning
The products are dietary supplements containing iron 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.
- 2022-04-13FDA-DevicePhilips North America LLCClass IIPhilips, REF M5072A, INFANT/CHILD - SMART PADS CARTRIDGE (0-8 YEARS). Smart PADS CARTRIDGE , (0-8 YEARS) <55 lbs/25 kg, CE 0123, NON-STERILE, Rx only FOR USE WITH HEARSTART DEFIBRILLATORS
There is a potential for AED pads to experience gel separation from the foam/tin backing when peeled from the plastic liner. The gel may fold onto itself resulting in reduced surface area or gel on the pad, or it may separate almost completely leaving only a small amount of gel on the pad.
- 2022-04-13FDA-DeviceDraeger Medical, Inc.Class IIBabylog VN500 Ventilator with Software 2.51.01 and Lower- intended for the ventilation neonatal patients from 0.4 kg (0.88 lbs) up to 10 kg (22 lbs) and pediatric patients from 5 kg (11 lbs) up to 20 kg (44 lbs) bodyweight Catalog Number: 8417400
Cybersecurity Improvement Action-not equipped against potential cyber security threats
- 2022-04-13FDA-FoodFruit Fresh Up, Inc.Class I1. Lexington Co-op 10oz Honeydew Chunk (2/cs) 2. EDU Kids 2 oz Honeydew tidbits
may be contaminated with Listeria monocytogenes
- 2022-04-13FDA-FoodFruit Fresh Up, Inc.Class IAll BBD 03/05/22 through 03/23/2022 1. Wegmans 32oz Cantaloupe Spears 2. Fresh Harvest 18oz Cantaloupe Spears 3. Tops Large Cantaloupe 4. Tops Small Cantaloupe 5. Lexington Co-op 10oz Cantaloupe Chunk (4/cs) 6. EDU Kids 2 oz. Cantaloupe tidbits
may be contaminated with Listeria monocytogenes
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