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.
- 2013-12-04FDA-FoodPlum IncClass IIPlum Organics Green Bean, Pear & Greek Yogurt Organic Baby Food, 4 oz. pouch. Flexible pouch with Resealable spout. Packaged for individual sale in 6 count cartons and in 4 count packages. Best By dates ranging from 08/05/14 to 12/08/14 and the letters AT. DISTRIBUTED BY: NEST COLLECTIVE, INC. EMERYVILLE, CA 94608 1-877-914-PLUM WWW.NEST-COLLECTIVE.COM
Manufacturing defect leading to post-process contamination.
- 2013-12-04FDA-FoodPlum IncClass IIPlum Organics Cherry & Sweet Corn Organic Baby Food, 4 oz. pouch. Flexible pouch with Resealable spout. Packaged for individual sale in 6 count cartons and in 4 count packages. Best By dates ranging from 08/05/14 to 12/08/14 and the letters AT. DISTRIBUTED BY: NEST COLLECTIVE, INC. EMERYVILLE, CA 94608 1-877-914-PLUM WWW.NEST-COLLECTIVE.COM
Manufacturing defect leading to post-process contamination.
- 2013-12-04FDA-FoodPlum IncClass IIPlum Organics Plum, Berry & Barley Organic Baby Food; 3.5 oz. Pouch; Flexible pouch with Resealable spout. Packaged for individual sale in 6 count cartons and in 4 count packages. Best By dates ranging from 08/05/14 to 12/08/14 and the letters AT. DISTRIBUTED BY: NEST COLLECTIVE, INC. EMERYVILLE, CA 94608 1-877-914-PLUM WWW.NEST-COLLECTIVE.COM
Manufacturing defect leading to post-process contamination.
- 2013-12-04FDA-FoodPlum IncClass IIPlum Organics Zucchini, Banana & Amaranth Organic Baby Food; 3.5 oz. Pouch; Flexible pouch with Resealable spout. Packaged for individual sale in 6 count cartons and in 4 count packages. Best By dates ranging from 08/05/14 to 12/08/14 and the letters AT. DISTRIBUTED BY: NEST COLLECTIVE, INC. EMERYVILLE, CA 94608 1-877-914-PLUM WWW.NEST-COLLECTIVE.COM
Manufacturing defect leading to post-process contamination.
- 2013-12-04FDA-FoodPlum IncClass IIPlum Organics Apple Raisin & Quinona Organic Baby Food; 3.5 oz. Pouch; Flexible pouch with Resealable spout. Packaged for individual sale in 6 count cartons and in 4 count packages. Best By dates ranging from 08/05/14 to 12/08/14 and the letters AT. DISTRIBUTED BY: NEST COLLECTIVE, INC. EMERYVILLE, CA 94608 1-877-914-PLUM WWW.NEST-COLLECTIVE.COM
Manufacturing defect leading to post-process contamination.
- 2013-12-04FDA-FoodPlum IncClass IIPlum Organics Sweet Potato, Mango & Millet Organic Baby Food; 3.5 oz. Pouch; Flexible pouch with Resealable spout. Packaged for individual sale in 6 count cartons and in 4 count packages. Best By dates ranging from 08/05/14 to 12/08/14 and the letters AT. DISTRIBUTED BY: NEST COLLECTIVE, INC. EMERYVILLE, CA 94608 1-877-914-PLUM WWW.NEST-COLLECTIVE.COM
Manufacturing defect leading to post-process contamination.
- 2013-12-04FDA-FoodPlum IncClass IIPlum Organics Peach, Apricot & Banana Organic Baby Food, 4 oz. pouch. Flexible pouch with resealable spout. Packaged for individual sale in 6 count cartons and in 4 count packages. Best By dates ranging from 08/05/14 to 12/08/14 and the letters AT. DISTRIBUTED BY: NEST COLLECTIVE, INC. EMERYVILLE, CA 94608 1-877-914-PLUM WWW.NEST-COLLECTIVE.COM
Manufacturing defect leading to post-process contamination.
- 2013-12-04FDA-FoodPlum IncClass IIPlum Organics Broccoli & Apple Organic Baby Food, 4 oz. pouch; Flexible pouch with Re-sealable spout. Packaged for individual sale in 6 count cartons and in 4 count packages. Best By dates ranging from 08/05/14 to 12/08/14 and the letters AT. DISTRIBUTED BY: NEST COLLECTIVE, INC. EMERYVILLE, CA 94608 1-877-914-PLUM WWW.NEST-COLLECTIVE.COM
Manufacturing defect leading to post-process contamination.
- 2013-12-04FDA-FoodPacific NutritionalsClass IIParaZYME, 90 capsules per bottle, is dietary supplement and sold under Renew Life brand. The UPC Code 6 31257 30990 7. The product is labeled in parts: "***PARAZYME***renew LIFE***The Digestive Care Company***90 Vegetable Capsules***Distributed by: ReNew Life Formulas***Palm Harbor, FL 34683***www.renewlife.com***1-800-830-1800***".
Dietary supplement product was made from ingredients that are contaminated with Chloramphenicol.
- 2013-12-04CPSCDavid's Place Off Price Clothing Co. Inc., a division of YMI Jeans, of Los Angeles, Calif.Wearever Girl’s Hooded Jacket Sets Recalled by David’s Place Due to Strangulation Hazard; Sold Exclusively at Burlington Coat Factory
The jackets sold with the set have drawstrings through the hood which pose a strangulation hazard to young children.
- 2013-12-04CPSCManhattan Group LLC, of Minneapolis, Minn.Manhattan Group Recalls Baby Rattles Due to Choking Hazard
The colored arches can break, creating a small part which poses a choking hazard to small children.
- 2013-11-27FDA-DeviceEbi, LlcClass IIBIOMET Spine, 5.5 TI 5.5x50mm Translation Screw Polaris 5.5 TI Spinal System. Rx Only. Non-Sterile. Intended for immobilization and stabilization as an adjunct to fusion as a pedicle screw fixation system
Polaris Translation Screw Failures were recently reported to Biomet Spine. These failures are generally described as dissociation of the screw head from the shaft of the Polaris Translation Screw.
- 2013-11-27FDA-DeviceHospira Inc.Class IThe GemStar Pump is a small and lightweight, single channel infusion device designed for use in the home, in the hospital, or anywhere electronic infusion is required. The GemStar Pump can be powered by AC mains adaptor, rechargeable battery pack, docking station, or two disposable AA alkaline batteries. When powered by batteries, The GemStar Pump is ideal for ambulatory patients.
The proximal and distal pressure sensor calibration can drift resulting in the pump failing the Proximal or Distal Occlusion Operational Test, as described in the GemStar Technical Service Manual, or reporting one of the following errors during device setup or infusion: 1) Cassette Check - D; 2) Cassette Check - P; 3) Proximal Occlusion; 4) Distal Occlusion; 5) Pressure Calibration Error; 6) Bad Pressure Sensor Event; 7) Bad Pressure State; 8) Distal Pressure is Out of Range; 9) Proximal Sensor is Out of Range. A pump with this issue may, instead of reporting an error, not detected occlusions or issue false occlusion alarms, which will stop the infusion and invoke visual and audible warnings to the user.
- 2013-11-27FDA-DeviceHospira Inc.Class IThe GemStar Pump is a small and lightweight, single channel infusion device designed for use in the home, in the hospital, or anywhere electronic infusion is required. The GemStar Pump can be powered by AC mains adaptor, rechargeable battery pack, docking station, or two disposable AA alkaline batteries. When powered by batteries, The GemStar Pump is ideal for ambulatory patients.
The proximal and distal pressure sensor calibration can drift resulting in the pump failing the Proximal or Distal Occlusion Operational Test, as described in the GemStar Technical Service Manual, or reporting one of the following errors during device setup or infusion: 1) Cassette Check - D; 2) Cassette Check - P; 3) Proximal Occlusion; 4) Distal Occlusion; 5) Pressure Calibration Error; 6) Bad Pressure Sensor Event; 7) Bad Pressure State; 8) Distal Pressure is Out of Range; 9) Proximal Sensor is Out of Range. A pump with this issue may, instead of reporting an error, not detected occlusions or issue false occlusion alarms, which will stop the infusion and invoke visual and audible warnings to the user.
- 2013-11-27FDA-DeviceGE Healthcare ItClass IICentricity Perinatal and Centricity Intensive Care is intended to be used in clinical departments healthcare delivery systems such as a Labor and Delivery, Postpartum Maternal Care, newborn Nursery, critical care units including Neonatal Intensive Care Units (NICU), and may also be used in physicians offices and outpatient clinics. This product is primarily intended to serve the purpose of electronic documentation of clinical data and is designed to accept, transfer, display, calculate, store an
1) Under rare network conditions, a Centricity Perinatal process may maintain an incorrect count of Patient slots in use which may lead to an inability to access the patient roster. The user is temporarily unable to review or edit form and chart information. This could result in a potential delay of care; however active fetal strips and permanent patient data storage are not affected. 2) When
- 2013-11-27FDA-FoodBio-Cat IncClass IIXylanase Enzyme Blends, bulk, custom blended formulations identified as xylanase 1000, xylanase 150,000 XU, synerzyme-ae, brizyme, Cellulase Special Blend OMRI, xylanase amylase blend, Bio-Cat Ruminant Enzyme, Feed Blend ws alkacel 20x, BC-XR, enzyme blend #2237, CHX blend, EB-7 multi-enzyme blend EB110311-01, EB020812-01, xylanase 70,000, nut 14-500, ultra blend 102 xylanase 10,000, bb cd blend #3, soy blend, amiron blend, Formula #121412b, erc530b, pn digestive blend, digest basic, blend 03
Raw material enzymes intended for further manufacturing of foods and dietary spplements may be contaminated with chloramphenicol.
- 2013-11-27FDA-FoodBio-Cat IncClass IIPectinase Enzyme Blends, bulk, custom blended formulations identified as pectinase 500, pectinase 1000, Pectinase 350 Endo-pg/gm, PC Blend 14, Nut 14-500, pectinase 3500, gastro blend 0111, Digestive Blend 021894, enzyme complex 5763, pectinase 1750, pectinase 350, EC-CHPX, enzyme blend for cyto grn, pectinase 150m, and Cellulase 3, packed in boxes or drums ranging from 1 kg to 25 kg, item # PECCI, labeled in part ***Manufactured by BIO-CAT, INC.9117 Three Notch Road Troy, Virginia 22974 Telepho
Raw material enzymes intended for further manufacturing of foods and dietary spplements may be contaminated with chloramphenicol.
- 2013-11-27FDA-FoodBio-Cat IncClass IICellulase Enzyme Blends, bulk, custom blended formulations identified as Cellulase BX and Celluase Conc, packed in boxes or drums ranging from 1 kg to 25 kg, item # CELIND, labeled in part ***Manufactured by BIO-CAT, INC.9117 Three Notch Road Troy, Virginia 22974 Telephone (800) 545-9052 Fax (434) 589-3301 E-mail: info@bio-cat.com Website: www.bio-cat.com***
Raw material enzymes intended for further manufacturing of foods and dietary spplements may be contaminated with chloramphenicol.
- 2013-11-27FDA-DrugL. Perrigo Co.Class IIAcetaminophen suspension liquid, 160 mg/5 mL, grape flavor, 2 FL OZ (59 mL) bottle co-packaged with an oral dosing syringe in a carton and sold under the following: a) equate Infants' Pain & Fever acetaminophen suspension liquid, Distributed by: Wal-Mart Stores, Inc., Bentonville, AZ 72716, NDC 49035-946-16, UPC 0 78742 09060 3; b) leader Infants' Pain & Fever acetaminophen suspension, Distributed by Cardinal Health, Dublin, OH 43017, NDC 37205-576-16, UPC 0 96295 12093 6; c) TopCare Infants'
Defective Delivery System: There is a remote potential that cartons of product could be co-packaged with an oral dosing syringe without dose markings.
- 2013-11-27FDA-DrugL. Perrigo Co.Class IIAcetaminophen suspension liquid, 160 mg/5 mL, dye-free grape flavor, 2 FL OZ (59 mL) bottle co-packaged with an oral dosing syringe in a carton and sold under the following: a) TopCare Infants' Pain & Fever acetaminophen, Distributed by Topco Associates LLC, Elk Grove Village, IL 60007, NDC 36800-766-16, UPC 0 36800 34650 5; b) Meijer Infants' Pain & Fever acetaminophen oral suspension, Dist. By Meijer Distribution, Inc., 2929 Waler Ave. NW, Grand Rapids, MI 49544, NDC 41250-766-16, UPC 7 1373
Defective Delivery System: There is a remote potential that cartons of product could be co-packaged with an oral dosing syringe without dose markings.
- 2013-11-27FDA-DrugL. Perrigo Co.Class IIAcetaminophen suspension liquid, 160 mg/5 mL, cherry flavor, 2 FL OZ (59 mL) bottle co-packaged with an oral dosing syringe in a carton and sold under the following: a) leader Infants' Pain & Fever acetaminophen suspension, Distributed by Cardinal Health, Dublin, Ohio 43017, NDC 37205-577-16, UPC 0 96295 12095 0; b) Walgreens infants' Pain & Fever acetaminophen oral suspension, Distributed By: Walgreen Co., 200 Wilmot Rd., Deerfield, IL 60015, NDC 0363-0161-16, UPC 3 11917 13221 1; c) Kroger I
Defective Delivery System: There is a remote potential that cartons of product could be co-packaged with an oral dosing syringe without dose markings.
- 2013-11-27FDA-DrugL. Perrigo Co.Class IIAcetaminophen suspension liquid, 160 mg/5 mL, dye-free cherry flavor, co-packaged with an oral dosing syringe in a carton and sold under the following: a) equaling infants' pain & fever acetaminophen suspension liquid, 2 FL OZ (59 mL) bottle, Distributed by SUPERVALU Inc., Eden Prairie, MN 55344, NDC 41163-590-16, UPC 0 41163 48657 7; b) Up & Up dye free infants' pain and fever acetaminophen suspension liquid, 2 FL OZ (59 mL) bottle, Distributed by Target Corporation, Minneapolis, MN 55403, ND
Defective Delivery System: There is a remote potential that cartons of product could be co-packaged with an oral dosing syringe without dose markings.
- 2013-11-26CPSCBurley Design LLC, of Eugene, Ore.Burley Design Recalls Tailwind Racks for Trailercycles Due to Fall Hazard
The top portion of the tailwind rack that connects trailercycles to a towing bicycle can break and allow the trailercycle to disconnect, posing a fall hazard.
- 2013-11-26CPSCLittle Willy's of, New York, N.Y.Little Willy's Recalls Hooded Sweatshirts Due to Strangulation Hazard
The hoodies have drawstrings through the hood or neck which pose a strangulation hazard to young children.
- 2013-11-26CPSCAmerican Boy and Girl (ABG), of Elizabeth, N.J.American Boy and Girl Recalls Infant Sandals Due to Choking Hazard; Sold Exclusively at Meijer Stores
The top strap can be pulled loose from the shoe, posing a choking hazard to the child.
- 2013-11-21CPSCAngelcare Monitors Inc.®, of Quebec, CanadaAngelcare Recalls to Repair Movement and Sound Baby Monitors After Two Deaths Due to Strangulation Hazard
The cord attached to the baby monitor's sensor pad is placed under the crib mattress, which poses a strangulation risk if the child pulls the cord into the crib and it becomes wrapped around the neck.
- 2013-11-21CPSCThe Bailey Boys, Inc., located in Saint Simons Island, Ga.Children’s Pajamas Recalled by The Bailey Boys Due to Violation of Federal Flammability Standard
The pajama pants fail to meet federal flammability standards for children's sleepwear, posing a risk of burn injuries to children.
- 2013-11-20FDA-DeviceSynthes USA HQ, Inc.Class IISynthes 8.5 MM Medullary Reamer Product Usage: An orthopedic manual surgical instrument is a nonpowered hand-held device intended for medical purposes to manipulate tissue, or for use with other devices in orthopedic surgery. This generic type of device includes the cerclage applier, awl, bender, drill brace, broach, bmT, corkscrew, countersink, pin crimper, wire cutter, prosthesis driver, extractor, file, fork, needle holder, impactor, bending or contouring instrument, compression instrume
Complaints were received for intraoperative reamer head breakages which can allow for unretrieved fragments of non-implant grade material.
- 2013-11-20FDA-FoodCgnp ManufacturingClass IIBeach Body Ultimate Reset Kit 2.0( each Kit consist of 1 bottle of the above optimize enzymes capsules product and 5 bottles of additional product) Product labeling reads in part:" BEACHBODY ULTIMATE RESET KIT 2.0*** BEACHBODY, LLC Santa Monica, CA***".
CGNP initiated this recall because the raw material Exclezyme received from Specialty Enzymes used by CGNP in the formulation of Beachbody Optimize Enzymes Capsules CG has been found to contain chloramphenicol.
- 2013-11-20FDA-FoodCgnp ManufacturingClass IIBeachbody Optimize Enzymes Capusles, 126 CT, 8 oz. Container size: JAR 8OZ WHITE 70MM NECK POLYPROPYLENE 126 capsules per bottle. Product labeling reads in part:" BEACHBODY ULTIMATE OPTIMIZE Promotes healthy metabolism and effective body funtions***DIETARY SUPPLEMENT 126 Capsules***BEACHBODY, LLC Santa Monica, CA***".
CGNP initiated this recall because the raw material Exclezyme received from Specialty Enzymes used by CGNP in the formulation of Beachbody Optimize Enzymes Capsules CG has been found to contain chloramphenicol.
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