Baby and kids' product recalls
6726 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.
- 2020-02-19FDA-FoodMarket America IncClass IIbliss anti-stress formula Dietary Supplement, 60 Tablets; Manufactured For and distributed by: Market America, Inc., 1302 Pleasant Ridge Road, Greensboro, NC 27409; UPC 8 48570 00470 3
Potentially undeclared Yohimbe 83 and complaints of adverse reactions: upset stomach, jittery, sweaty, lightheaded or dizzy.
- 2020-02-19CPSCContigo USA, of Chicago, Ill.Contigo Reannounces Recall of 5.7 Million Kids Water Bottles Due to Choking Hazard; Additional Incidents with Replacement Lids Provided in Previous Recall
The water bottle's clear silicone spout can detach, posing a choking hazard to children.
- 2020-02-12FDA-DeviceCenturion Medical Products CorporationClass IICenturion-Infant Feeding Kit IFK840 INFANT FEEDING KIT (8 FR X 40 IN)
Incomplete seals on the sterile package may compromise the sterility
- 2020-02-12FDA-DeviceCenturion Medical Products CorporationClass IICenturion Circumsion Trays as follows: Kit Code Product CIT1270 CIRCUMCISION TRAY CIT2365 CIRCUMCISION TRAY CIT2465 CIRCUMCISION TRAY CIT2470 CIRC TRAY W/UNIVERSAL CLAMP CIT2480 CIRCUMCISION TRAY W/CLAMP & 1.3 CM BELL CIT2480 CIRCUMCISION TRAY W/CLAMP & 1.3 CM BELL CIT2510 CIRCUMCISION TRAY W/1.1 CM CLAMP CIT2530A CIRCUMCISION TRAY CIT2545 CIRCUMCISION TRAY CIT2630 CIRCUMCISION TRAY CIT2705 CIRCUMCISION TRAY CIT2730 CIRCUMCISION TRAY CIT3000 CIRCUMCISION
Incomplete seals on the sterile package may compromise the sterility
- 2020-02-12FDA-FoodMerical, LLCClass IIMeijer Joint Health Triple Strength Formula Glucosamine Hydrochloride 1500 mg; Helps Overall Joint Physical Function; Unit Size - 40 count and 80 count - 2 tablets per day. Item Numbers: MEIJER7754 (40 count) & MEIJER7755 (80 count) UPC Code: 713733563024 & 713733563031 respectively Distributed by Meijer Distribution Inc. Grand Rapids, MI
Product label does not contain Crustacean Shellfish on the ingredient list or allergen information
- 2020-02-06CPSCPT Indigo Mandiri Sejahtera, of IndonesiaRooms To Go Recalls Patmos Chaise Lounge Chairs Due to Violation of Federal Lead Paint Ban (Recall Alert)
The paint used on the chair's metal frame contains levels of lead that exceed the federal lead paint standard. Lead is toxic if ingested by young children and can cause adverse health effects.
- 2020-02-06CPSCInfantino, of San Diego, Calif.Infantino Recalls Infant Carriers Due to Fall Hazard
The buckles on the infant carriers can break, posing a fall hazard.
- 2020-02-06CPSCSun Organic, of Phoenix, Ariz.Sun Organic Recalls Wintergreen Essential Oils Due to Failure to Meet Child Resistant Packaging Requirements; Risk of Poisoning
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 product is not child resistant, posing a poisoning risk if the contents are swallowed by young children.
- 2020-02-06CPSCJuratoys US Corp., of Millersburg, Pa.Juratoys Recalls Bead Maze Toys Due to Choking Hazard
The wooden triangle shape piece fails to meet the mandatory federal standard for small parts, posing a choking hazard to young children.
- 2020-02-05FDA-DeviceBard Peripheral Vascular IncClass IIBard Conquest 40 PTA Dilation Catheter, 8mm X 20mm x 75cm (CQF7582), 8mm x 40mm x 75cm (CQF7584); Recommended Guidewire .035"; Recommended Introducer 6F; Nominal Pressure 8atm, Rated Burst Pressure 40atm; Syringe inflation 1cc; UDI: (01)00801741060533(17)220228(10)REDQ3444
The catheter packaging incorrectly listed the balloon size as 8mm X 20mm instead of the intended size 8mm X 40mm. If undetected, the user will advance the longer than expected balloon to the lesion. The potential exists that upon inflation, non-diseased vessel, kidney or sections of the AV dialysis fistulae may be dilated, potentially causing a varying degree of injury. This may require additional medical or surgical intervention.
- 2020-01-30CPSCK-Apparel, of Buena Park, Calif.K-Apparel Recalls Children’s Lounge Pants Due to Violation of Federal Flammability Standard; Burn Hazard (Recall Alert)
The children's lounge pants fail to meet the flammability standard for children's sleepwear that requires sleepwear to be either snug-fitting or flame resistant, posing a risk of burn injuries to children.
- 2020-01-29CPSCGraco Children's Products Inc., of Atlanta, Ga.Graco Recalls Little Lounger Rocking Seats to Prevent Risk of Suffocation
Infant fatalities have been reported with other manufacturers' inclined sleep products, after infants rolled from their back to their stomach or side, or under other circumstances.
- 2020-01-29CPSCDelta Enterprise Corp., of New York, N.Y.Delta Enterprise Corp. Recalls Incline Sleeper with Adjustable Feeding Position for Newborns to Prevent Risk of Suffocation
Infant fatalities have been reported with other manufacturers' inclined sleep products, after the infants rolled from their back to their stomach or side, or under other circumstances.
- 2020-01-29CPSCEvenflo Company, Inc., of Piqua, OhioEvenflo Recalls Pillo Portable Napper Inclined Sleepers to Prevent Risk of Suffocation
Infant fatalities have been reported with other manufacturers' inclined sleep products, after the infants rolled from their back to their stomach or side, or under other circumstances.
- 2020-01-29CPSCSummer Infant (USA), Inc., of Woonsocket, R.I.Summer Infant Recalls SwaddleMe By Your Bed Inclined Sleepers to Prevent Risk of Suffocation
Infant fatalities have been reported with other manufacturers' inclined sleep products, after the infants rolled from their back to their stomach or side, or under other circumstances.
- 2020-01-24USDAClass IDo not eat Golden Pearl salted fish skin
Import Violation
- 2020-01-22FDA-FoodColumbia Bean & Produce, Inc.Class IIIDry Garbanzo Beans are sold under different brands and described as follows: -Bulk 2000 lbs. Totes. -CBP brand 25# Paper Bags 035084321925. -FIESTA brand 25# Paper Bags 035084225070. -Home Pride brand 50# Paper Bags 035084225070. -WinCo 24/1 lbs Small Pack 070552704305.
11.8 ppm of glyphosate was detected in dry garbanzo beans.
- 2020-01-22FDA-DrugWisconsin Pharmacal Company, LLCClass IIYeast Arrest, Homeopathic Formula, Vaginal Support suppositories, packaged in a) 14-count carton (NDC 68093-0730-1 and 68093-0730-3), b) 28-count carton (NDC 68093-0730-2 and 68093-0730-4), Manufactured for: Vitanica, 12401 SW Leveton Drive, Tualatin, OR 97062.
cGMP violations
- 2020-01-16CPSCBaby Trend, of Fontana, Calif.Baby Trend Recalls Tango Mini Strollers Due to Fall Hazard
Both of the stroller's hinge joints can release and collapse under pressure, posing a fall hazard to children in the stroller.
- 2020-01-09CPSCThesaurus Global Marketing Inc., of Doral, FLThesaurus Global Marketing Recalls Tricycles Due to Violation of the Federal Lead Paint Ban; Risk of Poisoning; Sold Exclusively at Amazon.com (Recall Alert)
Paint on the canopy's frame contains levels of lead that exceed the federal lead paint ban and tricycle components 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.
- 2020-01-08FDA-DeviceVilla Sistemi Medicali S.P.A.Class IIApollo EZ, Model Number 9784152036 - Product Usage: The Apollo EZ remote-controlled table is X-ray equipment that can be used to perform general radiographic and fluoroscopic examinations. The system is a fixed position type. The movements of the table and tube support are motorized and remote-controlled. Medical purpose is the diagnosis, visualization and documentation of various human diseases or injuries.
An amendment to the IFU and Service Manual is being issued to prescribe the replacement of the angulation chain after 8 years of service of the of the unit. After testing, it was found that due to metal fatigue under sever workload conditions, the angulation chain might fail before the expected lifetime of 10 years.
- 2020-01-08FDA-DeviceVilla Sistemi Medicali S.P.A.Class IIApollo DRF, Model Number 9784220831 - Product Usage: The remote controlled table Apollo DRF is an X-ray equipment that allows to perform general radiographic and fluoroscopic examinations. The system is a fixed position type. The movements of the table and tube support are motorized and remote-controlled. Medical purpose is the diagnosis, visualization and documentation of various human diseases or injuries.
An amendment to the IFU and Service Manual is being issued to prescribe the replacement of the angulation chain after 8 years of service of the of the unit. After testing, it was found that due to metal fatigue under sever workload conditions, the angulation chain might fail before the expected lifetime of 10 years.
- 2020-01-08FDA-DeviceVilla Sistemi Medicali S.P.A.Class IIApollo, Model Numbers 9784100231, 9784120131, 9784130131 - Product Usage: Apollo table is a remote controlled X-ray system suitable for radiography and fluoroscopy examinations. The system is stationary mounted. The movements of the table and the tube stand are motorized and remotely controlled. Medical purpose is the diagnosis, visualization and documentation of various human diseases or injuries.
An amendment to the IFU and Service Manual is being issued to prescribe the replacement of the angulation chain after 8 years of service of the of the unit. After testing, it was found that due to metal fatigue under sever workload conditions, the angulation chain might fail before the expected lifetime of 10 years.
- 2020-01-08FDA-DeviceVilla Sistemi Medicali S.P.A.Class IIJuno DRF, Model Number 709020 - Product Usage: General. multi-function x-ray systems capable of routine radiographs and general fluoroscopy procedures.
An amendment to the IFU and Service Manual is being issued to prescribe the replacement of the angulation chain after 8 years of service of the of the unit. After testing, it was found that due to metal fatigue under sever workload conditions, the angulation chain might fail before the expected lifetime of 10 years.
- 2020-01-03USDAClass IThrow away Kettle Cuisine lentil and beef soup
Misbranding, Unreported Allergens
- 2020-01-01FDA-DeviceBard Peripheral Vascular IncClass IIBARD MAX-CORE Disposable Core Biopsy Instrument - Product Usage: The core needle biopsy device is intended for use in obtaining biopsies from soft tissues such as liver, kidney, prostate, spleen, lymph nodes and various soft tissue tumors. It is not intended for use in bone.
During the firm's review of May 2019 complaint data, a significant increase in Disposable Core Biopsy Instrument complaints were observed for Failure to Fire, Firing Problem, and Failure to Obtain Samples.
- 2019-12-25FDA-DeviceNxStage Medical, Inc.Class IILow Volume Cartridge IFU (SKU CAR-125-B) used with the following devices: 1) NxStage One, Model NX1000-1; 2) NxStage VersiHD Cycler, Model Numbers: NX1000-16, and NX1000-16-A; 3) NxStage One, Model Numbers: NX1000-3 and NX1000-3-A; 4) NxStage One, Model Numbers: NX1000-10 and NX1000-10-A;
There is a potential patient health risk while performing chronic hemodialysis treatments in the home setting with for patients with low blood volume (2.4 Liters or less in a patient with body weight of 30kg or less) when prescribing larger dialysate volumes.
- 2019-12-25FDA-FoodStern Produce Company Inc.Class IIQueen Victoria Sweet Baby Broccoli from Ippolito International, packed in ice in half bushel boxes, 18 count bunches/case, pack date of Nov 07 [2019], twist tie label on each bunch. Packaged by Ippolito International, Salinas, CA 93901 (see photos of labels on pgs. 3-4 of Att A/B in Associated Docs).
Firm is recalling one lot of baby broccoli because it may be contaminated with bacteria contained in dripping ice water from a drain tray in the cooler.
- 2019-12-19CPSCToysmith of Sumner, Wash.Toysmith Recalls Light-Up Magic Wands Due to Choking and Ingestion Hazards
The battery cover can detach and expose the button-cell batteries, posing choking and ingestion hazards to young children.
- 2019-12-19CPSCBCI Burke Company, of Fond du Lac, Wis.BCI Burke Recalls Merge Playground Climbers Due to Entrapment Hazard
A welded rung opening on the sides of the climber poses an entrapment hazard to children.
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