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.
- 2021-08-24NHTSA-EquipmentDorel Juvenile GroupDorel Juvenile Group — Potential Head Injury with Lap Belt use/FMVSS 213
If the seat is installed with only the lap belt, the child has an increased risk of injury in the event of a crash.
- 2021-08-19CPSCQingdao Ruizexin Electronic Technology Co. Ltd., of ChinaInfant Bath Seats Recalled Due to Drowning Hazard; Imported by Frieyss and Sold Exclusively on Amazon.com (Recall Alert)
The bath seats fail to meet the federal safety standard for infant bath seats, including requirements for stability and leg openings, and can tip over while in use, posing a drowning hazard to babies.
- 2021-08-18FDA-DeviceStryker Medical Division of Stryker CorporationClass IICUB Pediatric Crib- intended to provide a pediatric patient support surface for medical purposes and to provide a method of transporting pediatric patients within a healthcare facility Model Number: FL19 Part #5050000000
Medical devices intended for use in a healthcare facility were distributed to residential customers and may be in use in a home environment. The product s labeling accurately identifies the correct use environment, but home users may not be aware of or fully understand these instructions intended for healthcare professionals
- 2021-08-18FDA-Food5000 Years Foods, Inc.Class II5000 Years Foods BABY NAPA KIMCHI in 128 oz, 64 oz, and 32 oz glass jars
potential to be contaminated with Listeria monocytogenes
- 2021-08-18CPSCSABG/Division of GCE International, of Winston-Salem, N.C.Nordstrom Recalls Children's Socks Due to Choking Hazard
The sock's pom pom can detach, posing a choking hazard to young children.
- 2021-08-18CPSCHallmark Marketing Company LLC, of Kansas City, Mo.Hallmark Recalls Teethers Due to Choking Hazard
The finished wooden ring can break into small parts, posing a choking hazard
- 2021-08-11FDA-DeviceBAXTER HEALTHCARE CORPORATIONClass IIKaguya Automated Peritoneal Dialysis System
Baxter Healthcare Corporation has identified that the AMIA Sharesource User Guide that is used with the AMIA Automated PD System cyclers incorrectly describes the function of the UF (Ultrafiltration) Limit setting as the ending criteria of the cyclers Extra Last Drain Mode. In some locations in the guide, it states that the UF volume achieved must exceed the programmed UF Limit before the cycler will end the Extra Last Drain, allowing the patient to end therapy or proceed to their last fill.
- 2021-08-11FDA-DeviceBAXTER HEALTHCARE CORPORATIONClass IISharesource Connectivity Platform for Use with the Amia Automated PD System
Baxter Healthcare Corporation has identified that the AMIA Sharesource User Guide that is used with the AMIA Automated PD System cyclers incorrectly describes the function of the UF (Ultrafiltration) Limit setting as the ending criteria of the cyclers Extra Last Drain Mode. In some locations in the guide, it states that the UF volume achieved must exceed the programmed UF Limit before the cycler will end the Extra Last Drain, allowing the patient to end therapy or proceed to their last fill.
- 2021-08-11FDA-DeviceROi CPS LLCClass IIRegard NEWBORN KIT, LD00201M, Item Number: 830016013. Medical convenience kit which includes an infant heel warmer.
Instructions for use updated to include the following cautionary statement for the heel warmer, "Activate away from the user's face and away from the infant and others."
- 2021-08-11FDA-DeviceROi CPS LLCClass IIRegard NEWBORN KIT, LD00201K, Item Number: 830016011. Medical convenience kit which includes an infant heel warmer.
Instructions for use updated to include the following cautionary statement for the heel warmer, "Activate away from the user's face and away from the infant and others."
- 2021-08-11FDA-DeviceROi CPS LLCClass IIRegard NEWBORN KIT, LD00201j, Item Number: 830016010. Medical convenience kit which includes an infant heel warmer.
Instructions for use updated to include the following cautionary statement for the heel warmer, "Activate away from the user's face and away from the infant and others."
- 2021-08-11FDA-FoodGrimmway Enterprises, Inc. dba Grimmway FarmsClass IOrganic Baby Peeled Carrots 12/12oz Steam-to-Serve
Carrot products may be contaminated with Salmonella
- 2021-08-11FDA-FoodGrimmway Enterprises, Inc. dba Grimmway FarmsClass IOrganic Baby Rainbow Carrots Brand name: O Organics 12 oz. (340 g) plastic bag UPC: 0 7989398162 8 12 oz. bag - Wegmans. Did not reach retail. Destroyed at DC's 12 oz. bag - GreenWise. Dis not reach retail, Destroyed at DC's
Carrot products may be contaminated with Salmonella
- 2021-08-11FDA-FoodGrimmway Enterprises, Inc. dba Grimmway FarmsClass IOrganic Peeled Baby-Cut Carrots Brand name: O Organics 1 lb. (454 g) plastic bag UPC: 0 7989340850 7 12 oz. packages - O Organics. Did not reach retail. Destroyed at DC's 12 oz. packages - Bunny Luv - Did not reach retail. Destroyed at DC's 12 oz. packages - HEB - Did not reach retail. Destroyed at DC's 12 oz. and 1 lb. packages - Market Basket. Did not reach retail. Destroyed at DC's 12 oz. and 1 lb. packages - Greenwise. Did not reach retail, Destroyed at DC's 1 lb. packages- Pur
Carrot products may be contaminated with Salmonella
- 2021-08-11FDA-FoodGrimmway Enterprises, Inc. dba Grimmway FarmsClass IOrganic Cut and Peeled Baby Carrots Brand name: Bunny Luv 1 lb.(454 g) plastic bag UPC: 0 3338390205 0;
Carrot products may be contaminated with Salmonella
- 2021-08-11CPSCShanghai One Top Corporation, of Shanghai, Chinadormakaba Recalls Delayed Egress Locks Due to Risk of Entrapment in an Emergency
The lockset can fail to open, posing an entrapment hazard and inability to vacate a location in an emergency.
- 2021-08-04FDA-DeviceSunrise Medical (US) LLCClass IIZippie Voyage, early intervention stroller - Product Usage: is manually operated by a caregiver for purposes of assisting a disabled person while providing supportive elements for assisted transportation and seating for a child or small adult not to exceed 75 pounds.
The seating system unexpectedly detached, which resulted in the seating system falling to the ground, causing injury.
- 2021-08-04FDA-DeviceSunrise Medical (US) LLCClass IIZippie Voyage, early intervention stroller - Product Usage: is manually operated by a caregiver for purposes of assisting a disabled person while providing supportive elements for assisted transportation and seating for a child or small adult not to exceed 75 pounds.
The seating system unexpectedly detached, which resulted in the seating system falling to the ground, causing injury.
- 2021-08-04FDA-DeviceHill-Rom, Inc.Class IIAffinity Four Birthing Bed-used as a birthing bed for women of child bearing age in an LDR (Labor, Delivery, Recovery) or LDRP (Labor, Delivery, Recovery, Postpartum) setting within the acute care Labor and Delivery market Model Numbers: P3700B, P3700C, P3700D, & P3700E
Latch mechanism on the Lift-Off foot section of the Affinity Four Birthing Bed is damaged, it could potentially cause the installed foot section to be improperly engaged onto the bed, could result in injury to the user due to a fall.
- 2021-08-04FDA-DeviceIon Beam Applications S.A.Class IIProteus 235-Proton Therapy System
if the user forgets to select the trigger input manually while beam gating is prescribed for the patient, the proton irradiation will be delivered without gating. If the beam is not gated as prescribed, the treatment field may be delivered with an error in position
- 2021-08-04FDA-FoodOld Souls Farms LLCClass IOld Souls Farm Green Bibb 2 lbs, 5 oz, Living Heads clamshells - 1oz 18 per case, 5oz 6 per case bulk bags - 1lb is 3 per case, 10lbs 1 per case, 25lbs 1 per case living are packed in plastic sleeves - 10 per case
Positive rainwater test for Listeria monocytogenes. The rainwater came in contact with product.
- 2021-08-04FDA-FoodRandall Foods, Inc.Class IIRANDALL KIDNEY BEANS 48OZ glass jars UPC 070095000308; RANDALL KIDNEY BEANS 24OZ glass jars UPC 070095000315; RANDALL KIDNEY BEANS 15.4OZ glass jars UPC 070095000339
Lack of functioning Temperature Indicating Devices in retorts
- 2021-07-29CPSCPuning Han Huini, of ChinaChildren's Sleepwear Recalled Due to Violation of Federal Flammability Standard and Burn Hazard; Sold Exclusively by Zoetop Business Co. Ltd. at www.SHEIN.com (Recall Alert)
The recalled sleepwear sets fail to meet flammability standards for children's sleepwear, posing a risk of burn injuries to children.
- 2021-07-29USDAClass IDo not use Greater Omaha Packing raw beef
Product Contamination
- 2021-07-28FDA-DeviceCardinal Health 200, LLCClass IIInfant Heel Warmer without Attachment Tab, Nonsterile, Active Product SKU MH00002N The infant heel warmer is activated at the point of care by squeezing the pouch. This mixes the substrates inside the pouch causing an exothermic chemical reaction, warming the pouch, which is then applied to the heel of an infant to aid in blood draws
A caution statement is being added to remind the user to activate away from face and infant as reports of pack rupture or leaking during activation may resulting in the contents splashing into the user s eyes or onto the infant. Potential harms associated with contact of the liquid inside the pouch are rash, burn and inflammation.
- 2021-07-28FDA-DeviceCardinal Health 200, LLCClass IIInfant Heel Warmer with Attachment Tab, Nonsterile, Active Product SKU MH00002T The infant heel warmer is activated at the point of care by squeezing the pouch. This mixes the substrates inside the pouch causing an exothermic chemical reaction, warming the pouch, which is then applied to the heel of an infant to aid in blood draws
A caution statement is being added to remind the user to activate away from face and infant as reports of pack rupture or leaking during activation may resulting in the contents splashing into the user s eyes or onto the infant. Potential harms associated with contact of the liquid inside the pouch are rash, burn and inflammation.
- 2021-07-28FDA-DeviceFresenius Medical Care Holdings, Inc.Class IIThe MTS Set is a single-use, sterile (EO), non-pyrogenic, optional accessory that provides additional connections/disconnections when used with a stay"safe compatible cycler set during acute and chronic PD treatment. The MTS Set utilizes the same PIN engagement technology used in Fresenius stay"safe Patient Connectors (K041792). The MTS Set consists of two (2) stay"safe PIN Connectors at the proximal end, tubing, and a Safe-Lock connector at the distal end. The MTS Set is attached to a cycler se
Exposed to freezing temperatures due to refrigerated truck malfunctions
- 2021-07-28FDA-DeviceFresenius Medical Care Holdings, Inc.Class IINaturaLyte Dry Bicarbonate Concentrate is composed of sodium bicarbonate powder and is used as one component in the preparation of dialysate in a 3-stream proportioning hemodialysis machine according to a physician s prescription. NaturaLyte Dry Bicarbonate Concentrate is formulated for use in 45X proportioning systems which proportion a nominal ratio of 1 : 1.72 : 42.28 (acid : bicarbonate : water) to generate dialysate. The dialysate is intended to be pumped through a dialyzer, creating an osm
Exposed to freezing temperatures due to refrigerated truck malfunctions
- 2021-07-28FDA-DeviceFresenius Medical Care Holdings, Inc.Class IICitrasate Liquid Acid Concentrate and NaturaLyte Liquid Acid Concentrate are each intended to be used as one component in the preparation of dialysate in a 3-stream proportioning hemodialysis machine according to a physician s prescription. Both concentrates are formulated for use in 45X proportioning systems which proportion a nominal ratio of 1 : 1.72 : 42.28 (acid : bicarbonate : water) to generate dialysate. The dialysate is intended to be pumped through a dialyzer, creating an osmotic gradi
Exposed to freezing temperatures due to refrigerated truck malfunctions
- 2021-07-28FDA-DeviceFresenius Medical Care Holdings, Inc.Class IICitrasate Dry Acid Concentrate and GranuFlo Dry Acid Concentrate are each intended to be used as one component in the preparation of dialysate in a 3-stream proportioning hemodialysis machine according to a physician s prescription. Both concentrates are formulated for use in 45X proportioning systems which proportion a nominal ratio of 1 : 1.72 : 42.28 (acid : bicarbonate : water) to generate dialysate. The dialysate is intended to be pumped through a dialyzer, creating an osmotic gradient acro
Exposed to freezing temperatures due to refrigerated truck malfunctions
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