Baby and kids' product recalls
6737 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.
- 2016-07-20FDA-DeviceHospira Inc.Class IIThe LifeCare Pump Model 4200 PCA Infuser makes possible the practical implementation of patient-controlled analgesia. The health care professional sets the prescribed dose, rates, and limits for the drug to be infused. The infuser can be set to operate in one of three modes: PCA Mode, Continuous Mode, and PCA + Continuous Mode. The LifeCare Pump Model 4200 PCA Infuser is designed with a number of mechanical, electrical, and software safeguards that prevent patient injury or drug abuse.
Hospira has received reports of PCA pumps not detecting distal occlusions, one of which resulted in a serious injury. The issue is caused by normal wear and tear on the Half Nut (the component/nut that travels up and down the lead screw) which prevents it from properly detecting the pressure build-up associated with a distal occlusion.
- 2016-07-19CPSCThings Remembered, Inc., of Highland Heights, OhioThings Remembered Recalls Children's Jewelry Due to Violation of Lead Standard
The clear surface coating on the bracelets and necklaces contain lead in excess of the allowable limit. Lead is toxic if ingested by young children and can cause adverse health issues.
- 2016-07-19CPSCGSI Outdoors, Inc., of Spokane, Wash.GSI Outdoors Recalls Children’s Water Bottles Due to Violation of Lead Standard; Sold Exclusively at L.L.Bean
The lead solder at the exterior base of the bottle contains high levels of lead. Lead is toxic if ingested by young children and can cause adverse health issues.
- 2016-07-15USDAClass IConAgra Foods Recalls Frozen Chicken and Beef Products Due to Possible Foreign Matter Contamination
Product Contamination
- 2016-07-14CPSCIKEA North America Services LLC, of Conshohocken, Pa.IKEA Recalls Safety Gates and Safety Gate Extensions Due to Fall Hazard
The locking mechanism can open unexpectedly, posing a fall hazard to children and other consumers.
- 2016-07-14CPSCThe Clorox Company, of Oakland, Calif.Three Types of Liquid Plumr Clog Removers Recalled by The Clorox Company Due to Failure to Meet Child-Resistant Closure Requirement
The recalled bottles are not child-resistant and children can remove the top, posing a risk of chemical burns and irritation to the skin and eyes. These products contain sodium hydroxide which is required by the Poison Prevention Packaging Act to be sealed with child-resistant packaging.
- 2016-07-13FDA-DeviceGE Healthcare, LLCClass IIGE Healthcare, Discovery MR750w
GE Healthcare has recently become aware of a potential safety issue with the patient bore heating on the Discovery MR750w. A small area on the bore surface, which is normally accessible to the patient, can get warm enough to cause a serious burn in the event the patient touches the bore and proper padding is not used. No injury has been reported to GE as a result of this issue.
- 2016-07-13FDA-FoodZarbee's Naturals Inc.Class IIIBaby Vitamin D Dietary supplement (in liquid form), 15 ml and 14 ml in glass bottle with dropper dispenser.
Some units of each lot may contain contaminants (elevated aerobic plate count) and do not meet acceptable visual appearance standards for the product.
- 2016-07-13FDA-FoodZarbee's Naturals Inc.Class IIIBaby Omega 3 Dietary supplement (in liquid form), 15 ml and 14 ml in glass bottle with dropper dispenser.
Some units of each lot may contain contaminants (elevated aerobic plate count) and do not meet acceptable visual appearance standards for the product.
- 2016-07-13FDA-DrugBee Extremely Amazed LLCClass IUltimate Formula Capsules, 250mg, 48-count bottles, Manufactured for: Zi Xiu Tang Success, LLC Trexlertown, PA 18087, USA www.zixiutangsuccess.com
Marketed Without An Approved NDA/ANDA: tainted product marketed as a dietary supplement. Product found to be tainted with undeclared sibutramine, an appetite suppressant that was withdrawn from the US market for safety reasons, making it an unapproved drug.
- 2016-07-13FDA-DrugLyne Laboratories, Inc.Class IIICyproheptadine Hydrochloride Syrup, Oral Solution USP, 2 mg/5 mL, packaged in an amber glass 473 mL (one pint) bottle with child-resistant screw closure, Rx only, Distributed by: Rising Pharmaceuticals, Inc., Allendale, NJ 07401, Manufactured by: Lyne Laboratories, Inc., Brockton, MA 02301, NDC 64980-0504-48
Subpotency: product assayed and found OOS for cyproheptadine
- 2016-07-12CPSCBernhardt Furniture Company, of Lenoir, N.C.Bernhardt Recalls Dressers and Nightstands Due to Serious Tip-Over Hazard
The recalled dressers are unstable if they are not properly anchored to the wall, posing a serious tip-over and entrapment hazard that can result in death or injuries to children.
- 2016-07-12USDAClass IThrow out Simmons chicken fritters
Product Contamination
- 2016-07-07CPSCLerado (Zhongshan) Industrial Co. Ltd., of ChinaPacific Cycle Recalls Swivel Wheel Jogging Strollers Due to Crash and Fall Hazards
The front wheel can become loose and detach, posing crash and fall hazards.
- 2016-07-06FDA-DeviceMedical Depot Inc.Class IIEZ adjust aluminum crutch under the following labels: 1) EZ adjust aluminum crutch, adult, 1 pair per case, 2) EZ adjust aluminum crutch, adult, 8 pairs per case, 3) EZ adjust aluminum crutch, youth, 1 pair per case, 4) EZ adjust aluminum crutch, youth, 8 pairs per case, 5) EZ adjust aluminum crutch, tall adult, 1 pair per case & 6) EZ adjust aluminum crutch, tall adult, 8 pairs per case
Tip crutch failure involving the bottom of the metal portion which comes in contact with ground
- 2016-07-06FDA-DeviceMedical Depot Inc.Class IIAluminum crutch under the following labels: 1) Aluminum crutch, adult, 1 pair per case, 2) Aluminum crutch, adult, 8 pairs per case, 3) Aluminum crutch, youth, 1 pair per case, 4) Aluminum crutch 8 pairs per case, 5) Aluminum crutch, tall adult, 1 pair per case & 6) Aluminum crutch, tall adult, 8 pairs per case
Tip crutch failure involving the bottom of the metal portion which comes in contact with ground
- 2016-07-06FDA-DevicePentax Medical CompanyClass IICholedocho-Nephroscope Intended to provide optical visualization of and therapeutic access to the Abdominal Cavity. This anatomy includes, but is not restricted to, the organs, tissues and subsystems: Biliary tree with access to the Common bile Duct, Hepatic Duct, Cystic Duct, Kidney, Renal Cavity and Renal Calyces. The instrument is introduced via percutaneous cut when indications consistent with the need for procedure are observed in adult and pediatric patient populations.
Pentax has become aware that operational/cleaning accessories and therapeutic devices (e.g., clips, stents, balloons, etc.) can become lodged in an endoscope's instrument channel.
- 2016-07-06CPSCEmbrace Technologies, of San FranciscoLittle Lotus Baby Swaddles and Sleeping Bags Recalled by Embrace Technologies Due to Choking Hazard (Recall Alert)
The shoulder snaps on the baby swaddles and sleeping bags can break or detach, posing a choking hazard to young children.
- 2016-07-06USDAClass IThrow out recalled P.F. Chang's frozen meals
Product Contamination
- 2016-07-05NHTSA-EquipmentCombi USA, Inc.Combi USA, Inc. — Excessive Force Transmitted to Child/FMVSS 213
In the event of a crash, the seat occupant is at an increased risk of injury.
- 2016-06-29FDA-DeviceFresenius Medical Care Renal Therapies Group, LLCClass IICrit Line in a Clip (CLiC). CliC P/N: CL 10041001 CLiC is a continuous real-time monitor for non-invasive hematocrit oxygen saturation and percent change in blood volume measurement during hemodialysis treatment. Used in conjunction with the Fresenius 2008T Hemodialysis Machines as follows: Model: 190895 2008T GEN 2 BIBAG w/o CDX 190713 2008T Hemodialysis SYS with CDX 190858 2008T Hemodialysis System w/o CDX 190766 2008T Hemodialysis System w/o CDX
Use of the Blood Pressure Graph located on the Crit-Line screen of the 2008T Hemodialysis Machine may result in a frozen screen, possibly causing the blood pump to stop.
- 2016-06-29FDA-FoodLet's Talk Health, Inc.Class ILet's Talk Health Agua Vitae Kids Multi-Vitamin Liquid 16 oz. UPC #91131180280
Undeclared whey protein which contains milk and soy lecithin.
- 2016-06-29CPSCSaro Trading Company of Burbank, Calif.Children’s Nightgowns Recalled by Saro Trading 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.
- 2016-06-28CPSCIKEA North America, of Conshohocken, Pa.Following an Additional Child Fatality, IKEA Recalls 29 Million MALM and Other Models of Chests and Dressers Due to Serious Tip-Over Hazard; Consumers Urged to Anchor Chests and Dressers or Return for Refund
The recalled chests and dressers are unstable if they are not properly anchored to the wall, posing a serious tip-over and entrapment hazard that can result in death or injuries to children.
- 2016-06-22FDA-DeviceNavilyst Medical, Inc., an AngioDyamics CompanyClass IIVaxcel PICC with PASV Intermediate Safety MST Kit under the following labels: 1) 3F, UPN H965454370, 2) 4F UPN M001455940 & 3) 5F UPN M001455980 The Vaxcel PICC with PASV is indicated for use in establishing peripheral access to the central venous system for administration of fluids including, but not limited to, hydration agents, antibiotics, chemotherapy, analgesics, nutritional therapy, and blood products. It is also indicated for blood specimen withdrawal. This product is intended for centr
PICC catheters that contain valve(s) manufactured prior to July 15, 2014 lack a manufacturing specification change that reduces the incidence of hemolysis during blood sampling through the PICC catheter.
- 2016-06-22FDA-DeviceNavilyst Medical, Inc., an AngioDyamics CompanyClass IIVaxcel PICC with PASV Introducer Kit under the following labels: 1) 4F, UPN M001455910, Rx ONLY The Vaxcel PICC with PASV is indicated for use in establishing peripheral access to the central venous system for administration of fluids including, but not limited to, hydration agents, antibiotics, chemotherapy, analgesics, nutritional therapy, and blood products. It is also indicated for blood specimen withdrawal. This product is intended for central venous access in adults, children and infants
PICC catheters that contain valve(s) manufactured prior to July 15, 2014 lack a manufacturing specification change that reduces the incidence of hemolysis during blood sampling through the PICC catheter.
- 2016-06-22FDA-DeviceNavilyst Medical, Inc., an AngioDyamics CompanyClass IIVaxcel PICC with PASV MST-60 Kit under the following labels: 1) 3F, UPN H965454360, Rx ONLY, 2) 4F, UPN M001454590, Rx ONLY, 3) 5F, UPN's M001454640, M001454740 & M001454790, Rx ONLY The Vaxcel PICC with PASV is indicated for use in establishing peripheral access to the central venous system for administration of fluids including, but not limited to, hydration agents, antibiotics, chemotherapy, analgesics, nutritional therapy, and blood products. It is also indicated for blood specimen withdraw
PICC catheters that contain valve(s) manufactured prior to July 15, 2014 lack a manufacturing specification change that reduces the incidence of hemolysis during blood sampling through the PICC catheter.
- 2016-06-22FDA-DeviceNavilyst Medical, Inc., an AngioDyamics CompanyClass IIVaxcel PICC with PASV MST-30 Kit under the following labels: 1) 4F, UPN M001454570, Rx ONLY, 2) 5F, UPN M001454620 & UPN M001454720, Rx ONLY & 3) 6F, UPN M001454770, Rx ONLY. The Vaxcel PICC with PASV is indicated for use in establishing peripheral access to the central venous system for administration of fluids including, but not limited to, hydration agents, antibiotics, chemotherapy, analgesics, nutritional therapy, and blood products. It is also indicated for blood specimen withdrawal. This
PICC catheters that contain valve(s) manufactured prior to July 15, 2014 lack a manufacturing specification change that reduces the incidence of hemolysis during blood sampling through the PICC catheter.
- 2016-06-22FDA-DeviceNavilyst Medical, Inc., an AngioDyamics CompanyClass IIVaxcel PICC with PASV IR-145 Kit under the following labels: 1) 4F, UPN M001454580, Rx ONLY, 2) 5F, UPN M001454630, Rx ONLY & 3) 6F, UPN M001454780, Rx ONLY The Vaxcel PICC with PASV is indicated for use in establishing peripheral access to the central venous system for administration of fluids including, but not limited to, hydration agents, antibiotics, chemotherapy, analgesics, nutritional therapy, and blood products. It is also indicated for blood specimen withdrawal. This product is intend
PICC catheters that contain valve(s) manufactured prior to July 15, 2014 lack a manufacturing specification change that reduces the incidence of hemolysis during blood sampling through the PICC catheter.
- 2016-06-22FDA-DeviceNavilyst Medical, Inc., an AngioDyamics CompanyClass IIVaxcel PICC with PASV Introducer Kit under the following labels: 1) 4F, UPN M001454560, Rx ONLY & 2) 5F, UPN M001454610, Rx ONLY. The Vaxcel PICC with PASV is indicated for use in establishing peripheral access to the central venous system for administration of fluids including, but not limited to, hydration agents, antibiotics, chemotherapy, analgesics, nutritional therapy, and blood products. It is also indicated for blood specimen withdrawal. This product is intended for central venous acces
PICC catheters that contain valve(s) manufactured prior to July 15, 2014 lack a manufacturing specification change that reduces the incidence of hemolysis during blood sampling through the PICC catheter.
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