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Page 14 of 15Severity
- MEDLINE convenience kits labeled as: 1) GENERAL AAA #11-RF, REF CDS840261AB; 2) CAROTID ENDARTERECTOMY CDS-LF, REF CDS983637I; 3) PERIPHERAL VASCULAR CDS, REF CDS983723J; 4) ACH OPEN HEART, REF CDS983773J; 5) VASCULAR, REF CDS984255K; 6) OPEN HEART CHILDRENS PACK-LF, REF DYNJ0161262C; 7) VASCULAR PACK-LF, REF DYNJ0421380P; 8) GEN FEM POP #14-RF, REF DYNJ21877W; 9) VASCULAR PACK, REF DYNJ22350L; 10) GENERAL CAROTID/AV TRAY #15-RF, REF DYNJ27432AC; 11) OPEN HEART PACK, REF D
Medline Industries, LP is issuing a recall for specific item(s) and lot(s) of Medline Kits containing SafeAir Smoke Evacuation Pencils. Stryker Instruments has expanded the scope of their recall of SafeAir Smoke Evacuation Pencils previously initiated in October 2024, adding an additional 47 lots to the scope of the recall. The initial recall was due to the potential for product to activate without manual input when plugged into a power source or remain active after buttons are released.
FDANov 26, 202520 products
- MOSAIQ Oncology Information System Software Builds 3.1.3, 3.2.1, 3.2.2 & 3.2.3.0 Software Version and UDI Codes: 3.1.3.0 (01)07340201500026(10)3.1.3.0 3.1.3.1 (01)07340201500026(10)3.1.3.1 3.1.3.2 (01)07340201500026(10)3.1.3.2 3.1.3.3 (01)07340201500026(10)3.1.3.3 3.1.3.4 (01)07340201500026(10)3.1.3.4 3.2.1.0 (01)07340201500071(10)3.2.1.0 3.2.1.1 (01)07340201500071(10)3.2.1.1 3.2.1.2 (01)07340201500071(10)3.2.1.2 3.2.1.3 (01)07340201500071(10)3.2.1.3 3.2.1.4 (01)07340201500071(10)
When appending a care plan that contains one or more wave medication orders, the occurrence and frequency of the appended orders may not match the intended schedule.
FDANov 26, 2025
Outdoor Master Children's and Youth Helmets Recalled Due to Risk of Serious Injury or Death from Head Injury; Violates Mandatory Standard for Bicycle Helmets; Sold and Imported by Outdoor MasterThe recalled children's and youth helmets violate the mandatory safety standard for bicycle helmets. Particularly, the helmets do not comply with the positional stability and coverage requirements. The helmets can fail to protect the user in the event of a crash, posing a risk of injury or death due to head injury.
CPSCNov 26, 2025Outdoor Master
Convertible High Chairs Recalled Due to Risk of Serious Injury or Death from Fall and Entrapment Hazards; Violate Mandatory Standard for High Chairs; Sold on Amazon by RotinyardThe high chairs violate the mandatory standard for high chairs because they were sold without the required attached restraint system, posing a deadly fall hazard to babies. In addition, a child's head can become trapped in the opening between the seat and tray, posing a deadly entrapment hazard.
CPSCNov 26, 2025
Sofoliana and Glotika Baby Loungers Recalled Due to Risk of Serious Injury or Death from Entrapment and Fall Hazards; Violates Mandatory Standard for Infant Sleep Products; Sold on Amazon by Bosen USThe recalled baby loungers violate the mandatory safety standard for Infant Sleep Products. The sides are too low to contain an infant and the enclosed openings at the foot of the loungers are wider than allowed, posing serious risks of fall and entrapment hazards to infants. In addition, the baby loungers do not have a stand, posing a fall hazard if used on elevated surfaces. These violations create an unsafe sleeping environment and can cause death or serious injury.
CPSCNov 26, 2025
Ikuso Safety Gates Recalled Due to Risk of Serious Injury or Death to Children from Entrapment; Violates Mandatory Standard for Gates and Enclosures; Sold on Amazon by IkusoThe recalled gates violate the mandatory standard for expansion gates and expandable enclosures because a child's torso can fit through the opening between the gate slat and the side wall, posing a risk of serious injury or death due to entrapment.
CPSCNov 26, 2025Ikuso
Macardac Baby Loungers Recalled Due to Risk of Serious Injury or Death from Entrapment and Fall Hazards; Violates Mandatory Standard for Infant Sleep Products; Sold on Amazon by Macardac ProductsThe recalled baby loungers violate the mandatory safety standard for Infant Sleep Products. The sides are too low to contain an infant and the enclosed openings at the foot of the loungers are wider than allowed, posing serious risks of fall and entrapment hazards to infants. In addition, the baby loungers do not have a stand, posing a fall hazard if used on elevated surfaces. These violations create an unsafe sleeping environment and can cause death or serious injury.
CPSCNov 26, 2025
Alinux Baby Loungers Recalled Due to Risk of Serious Injury or Death from Entrapment and Fall Hazards; Violates Mandatory Standard for Infant Sleep Products; Sold on Amazon by WinkidsThe recalled baby loungers violate the mandatory safety standard for Infant Sleep Products. The sides are too low to contain an infant and the enclosed openings at the foot of the loungers are wider than allowed, posing serious risks of fall and entrapment hazards to infants. In addition, the baby loungers do not have a stand, posing a fall hazard if used on elevated surfaces. These violations create an unsafe sleeping environment and can cause death or serious injury to infants.
CPSCNov 26, 2025
Ebern Designs Ojaswi 12-Drawer Dressers Recalled Due to Risk of Serious Injury or Death from Tip-Over and Entrapment; Violates Mandatory Standard for Clothing Storage Units; Manufactured and Sold by Ebern DesignsThe recalled dressers are unstable if they are not anchored to the wall, posing tip-over and entrapment hazards that can result in serious injuries or death to children. The dressers violate the mandatory standard as required by the STURDY Act.
CPSCNov 26, 2025
Romorgniz Fabric 12- and 13-Drawer Dressers Recalled Due to Risk of Serious Injury or Death from Tip-Over and Entrapment; Violates Mandatory Standard for Clothing Storage Units; Sold on Amazon by RomorgnizThe recalled dressers are unstable if they are not anchored to the wall, posing serious tip-over and entrapment hazards that can result in injuries or death to children. The dressers violate the mandatory standard as required by the STURDY Act.
CPSCNov 20, 2025
Magnet Fidget Spinner Sets Recalled Due to Risk of Serious Injury or Death from Magnet Ingestion; Violates Mandatory Standard for Toys; Sold on Amazon by AnzmtosnThe recalled magnet spinner sets violate the mandatory standard for toys because the sets contain loose magnets, posing an ingestion hazard to children. When high-powered magnets are swallowed, they can attract each other, or other metal objects, and become lodged in the digestive system. This can result in perforations, twisting, and/or blockage of the intestines, blood poisoning and death.
CPSCNov 20, 2025
Mallimoda Children's Pajama Sets Recalled Due to Risk of Serious Injury or Death from Burn Hazard; Violates Mandatory Standards for Children's Sleepwear; Sold on Amazon by MallimodaThe recalled pajama sets violate the mandatory standards for children's sleepwear, posing a risk of serious injuries or deadly burn hazard to children.
CPSCNov 20, 2025
Play Yards Recalled Due to Risk of Serious Injury or Death from Suffocation and Entrapment Hazards; Violate Mandatory Standard for Play Yards; Sold on Amazon by Anna QueenThe play yards violate the mandatory standard for play yards. Infants can become entrapped under the mattress or between the side of the play yard and the mattress, posing a risk of serious injury or deadly suffocation hazard.
CPSCNov 20, 2025Anna Queen
Little Partners Recalls Children's Grow 'N Stow Folding Learning Towers Due to Fall HazardThe platform inside the tower can collapse, posing a fall hazard to young children.
CPSCNov 20, 2025
Bearlala Baby Loungers Recalled Due to Risk of Serious Injury or Death from Entrapment and Fall Hazards; Violates Mandatory Standard for Infant Sleep Products; Sold on Walmart.com by NuoxuannThe recalled baby loungers violate the mandatory standard for Infant Sleep Products. The sides are too low to contain an infant. The enclosed openings at the foot of the loungers are wider than allowed, posing fall and entrapment hazards to infants. In addition, the baby loungers do not have a stand, posing a fall hazard, if used on elevated surfaces. These violations create an unsafe sleeping environment and can cause death or serious injury to infants.
CPSCNov 20, 2025
AliExpress Recalls Convertible Strollers Due to Risk of Serious Injury or Death from Fall Hazard; Violates Mandatory Standard for StrollersThe stroller violates the mandatory standard for strollers because the restraint system can fail, posing a risk of serious injury or deadly fall hazard.
CPSCNov 20, 2025
Zigjoy Sleep Sacks with Feet Recalled Due to Risk of Serious Injury or Death from Burn Hazard; Violates Mandatory Standard for Children's Sleepwear; Sold by Zigjoy-USThe recalled sleep sacks violate the mandatory flammability standard for children's sleepwear, posing a burn hazard and risk of serious injury or death to children.
CPSCNov 13, 2025
Great Lakes Wholesale International Recalls Select Battery Packs Due to Battery Ingestion; Violates Federal Statute for Child-Resistant Packaging of Button Cell and Coin BatteriesThe button cell and lithium coin batteries are not in child-resistant packaging and do not bear the warning labels required under Reese's Law. If a child swallows button cell or coin batteries, the ingested batteries can cause serious injuries, including internal chemical burns and death.
CPSCNov 13, 2025
Zippee Silicone Activity Toys Recalled Due to Risk of Serious Injury or Death from Choking; Violates Mandatory Standard for Toys; Imported by Mobi GamesThe recalled silicone activity toys contain spherical ends that can reach the back of the throat, posing a serious choking hazard to children.
CPSCNov 13, 2025
Bettina Doll Sets Recalled Due to Risk of Serious Injury or Death from Battery Ingestion; Violates Mandatory Standard for Toys; Sold on Amazon by Shantou Chenghai Xingzigu Toy IndustryThe doll sets violate the mandatory standard for toys because the battery compartment of the unicorn contains button cell batteries that can be easily accessed by children. When button cell or coin batteries are swallowed, the ingested batteries can cause serious injuries, internal chemical burns and death.
CPSCNov 13, 2025
- Osstem dental X-ray systems recalled for missing labeling statement
Osstem Implant is voluntarily correcting the labeling on three dental X-ray systems. The labels may be missing a required certification statement that the products comply with federal radiological health performance standards. No injuries have been reported.
ModerateFDANov 12, 2025Osstem3 products
WYBITNY Bed Rails Recalled Due to Risk of Serious Injury or Death from Entrapment; Violates Mandatory Standard for Children's Portable Bed Rails; Sold on Amazon by WYBITNYThe recalled bed rails violate the mandatory standard for children's portable bed rails because, when installed adjacent to the bed, the child can become entrapped in the enclosed openings, the openings on the side of the mattress, and the openings on top of the mattress, posing a risk of serious injury or death due to entrapment.
CPSCNov 6, 2025WYBITNY
Inkari Plush Alpaca Toys Recalled Due to Risk of Serious Injury or Death from Choking Hazard; Violate Small Parts Ban; Imported by InkariThe recalled toys are intended for children under three years of age and the eyes can detach, which violates the small parts ban, posing a choking hazard to children.
CPSCNov 6, 2025
Sanven Technology Recalls Vevor Baby Swings Due to Risk of Serious Injury from Suffocation Hazard; Violates Mandatory Standard for Infant Sleep Products and Inclined Sleepers BanThe swings were marketed for infant sleep and have an incline angle greater than 10 degrees, violating the mandatory safety standard for Infant Sleep Products and the ban on inclined sleepers under the Safe Sleep for Babies Act, posing a deadly suffocation risk.
CPSCNov 6, 2025Sanven Technology
Umeyda Nightgowns Recalled Due to Risk of Serious Injury or Death from Burns; Violate Mandatory Standards for Children's Sleepwear; Sold on Amazon by Umeyda CompanyThe recalled nightgowns violate the mandatory flammability standards for children's sleepwear, posing a risk of burn injuries to children.
CPSCNov 6, 2025
Napei Infant Bath Tubs Recalled Due to Risk of Serious Injury or Death from Ingestion Hazard; Violates Mandatory Standard for Consumer Products with Button Cell Batteries; Sold on Amazon by Sefon StoreThe recalled infant bath tubs violate the mandatory standard for consumer products containing button cell or coin batteries because the built-in thermometer contains button cell batteries that can be accessed easily by children. When button cell or coin batteries are swallowed, the ingested batteries can cause serious injuries, internal chemical burns and death.
CPSCNov 6, 2025
Three-Wheeled Children's Scooters Recalled Due to Fall Hazard; Imported by Konges SløjdThe left front wheel can detach during use, posing a fall hazard.
CPSCNov 6, 2025
F&F Fine Wines Recalls Kirkland Signature Valdobbiadene Prosecco Entrapment or Suffocation; Violates Mandatory Standards for Mattresses; Sold on Amazon by Mengna Criblike Mattresses Recalled Due to Risk of Serious Injury or Death from EntrapmentThe aftermarket mattresses violate the mandatory standard for crib mattresses, as the mattresses may not adequately fit certain play yards or non-full-sized cribs, posing a deadly entrapment hazard. Babies can suffocate in gaps between an undersized mattress, or extra padding, and side walls of a product, especially when the infant's face becomes trapped against the side and the mattress, preventing the infant from breathing. The non-full-sized crib mattress also fails to meet the mandatory standard for mattress set flammability.
CPSCNov 6, 2025Mengna
- Sharesource Connectivity Platform for Use with Homechoice Claria Product Code 5CGM01 software versions 7.13.3 (China), 8.13.2 (APAC and Korea), and 8.13.4 (US, EMEA, and LATAM)
Vantive has identified a software defect within the Sharesource Claria software, which may cause a patient s updated prescription program settings to not be properly saved on the actual cycler that the patient is using to perform their therapy. As a result, the clinician may think that the patient is receiving the correct prescribed therapy because of what is erroneously displayed on the clinician's remote Sharesource application, when in fact the cycler that is with the patient is actually delivering an outdated and incorrect therapy.
FDANov 5, 2025Vantive