147 recalls tagged with “mandatory standard violation”.
GET TESTED INTERNATIONAL AB recalled the GI Microbiome Profile XL on November 3, 2025, due to distribution without premarket approval. Three units were distributed nationwide in the U.S. Patients and healthcare providers should stop using this device immediately.
GET TESTED INTERNATIONAL AB recalled 1,218 D-Dimer Test kits nationwide after distributing without premarket approval. The recall cites distribution without FDA premarket approval or clearance. Healthcare providers and patients should stop using the device immediately and follow all recall instructions.
100% of reported issues involve distribution without premarket approval. GET TESTED INTERNATIONAL AB’s HbA1c Diabetes Test was distributed nationwide in the United States without FDA clearance. Stop using the product immediately and follow the manufacturer’s recall instructions.
GET TESTED INTERNATIONAL AB’s Akkermansia Test recall covers 24 units distributed nationwide in the United States. The device was distributed without premarket approval or clearance. Patients and healthcare providers should stop using the device immediately and follow the manufacturer’s recall instructions.
GET TESTED INTERNATIONAL AB recalled 60 Trichomonas Vaginalis tests distributed nationwide in the United States after regulators found no premarket approval or clearance. The recall stems from a violation of regulatory requirements. Patients and healthcare providers should stop using this device immediately and follow the manufacturer’s recall instructions.
GET TESTED INTERNATIONAL AB recalled 6 Gut Microbiome Test Small units distributed nationwide in the United States. The devices were distributed without FDA premarket approval or clearance. Patients and healthcare providers should stop using the device immediately and follow the manufacturer’s recall instructions.
Philips North America recalled 1,913,441 IntelliVue MX100 patient monitors due to potential alarm failure. The recall is active as of December 2025. The manufacturer warns patients and healthcare providers to stop using affected devices and follow recall instructions. Contact Philips North America LLC for guidance.
Modera recalled its Pack N Play Play Yard Mattresses sold at multiple retailers after a potential entrapment risk. The products may not fit play yards properly, creating dangerous gaps. Stop using the recalled mattresses and contact Modera for a full refund.
DINBooonLUX recalled 12-Inch Full-Size Hybrid Mattresses sold on Amazon. The mattresses violate the mandatory flammability standard and pose a risk of serious injury or death in a fire. Stop using the mattress and contact DINBooonLUX for a full refund.
WLIVE expanded its recall to include 16-drawer fabric dressers sold on Amazon. The hazard is tip-over and entrapment risk that can cause serious injury or death to children. Stop using the recalled dressers immediately if not anchored to a wall and contact WLIVE for a full refund.
The Kroger Co. recalls Halloween-themed Skeleton Wax Candles sold at Kroger stores due to a fire hazard. The candle contains flammable ornaments that create a burn risk. Consumers should stop using the candle immediately and return it to any Kroger store for a full refund.
Philips North America recalled 2,341 Incisive CT systems worldwide after screws securing the tube heat exchanger on the rotating scanner may loosen after replacement. A detached component could contact other parts during rotation. Hospitals should stop using affected devices and await recall instructions from Philips.
B. Braun Medical recalled 46,250 SAFELINE IV sets sold worldwide on Oct. 29, 2025. The devices pose a backflow risk from secondary piggyback IV containers into primary lines and may fail to prime due to occlusion. Hospitals and patients using Infusomat Space Large Volume Pump, Outlook Pump, or Vista Basic Pump with SAFELINE sets should stop use immediately and await manufacturer instructions.
Siemens Medical Solutions USA recalls the MAMMOMAT Inspiration operator table. The recall covers six units worldwide, including three in the United States. The operator table was sold with a bus-installation kit and is not designed or released for bus installations. Stop using the device immediately and contact Siemens for instructions.
Bealife recalled its 5-Drawer Dressers on Oct. 23, 2025. The dressers are white and measure 32 inches high, 28 inches wide, and 16 inches deep. The model AP23-W is printed on packaging but not on the dresser itself. Consumers should stop using unanchored dressers and seek a full refund.
LEACHOI recalled its adult portable bed rails sold on Amazon on Oct. 23, 2025. The recall covers ASIN B0BZVCG2R5 due to a risk of entrapment and suffocation and missing hazard labels. Stop using the recalled rails and seek a full refund from LEACHOI.
Olympia Tools International recalls Pack-N-Stroll Premium Folding Utility Wagons sold at Costco after authorities determined the product can trap a child’s head and cause serious injury or death. The defect is an opening between the organizational tray and the sidewall. The wagon also lacks a restraint system. Stop using the wagon now and return it to Costco for a full refund.
WLIVE recalled its Fabric 12-Drawer Dressers sold on Amazon after identifying a serious tip-over and entrapment hazard. The dressers are unstable if not anchored to the wall, violating the mandatory standard for clothing storage units under the STURDY Act. Consumers should stop using the recalled dressers immediately and contact WLIVE for a full refund.
Belivium recalled its baby loungers sold on Amazon after safety concerns tied to suffocation and entrapment hazards. The loungers have a foam sleeping pad and padded bumpers with a cloth cover. Parents should stop using the loungers immediately and contact Belivium for a full refund.
Calico Brands recalls the Scripto Premium Torch due to fire and burn hazards. The recall covers torches with a four-position adjustable metal nozzle and a hands-free operation lock. Consumers should stop using the recalled torches and return them to the retailer for a full refund or store credit.