mandatory standard violation Recalls

GET TESTED INTERNATIONAL AB Recalled GI Microbiome Profile XL

Distribution without premarket approval/clearance.

GET TESTED INTERNATIONAL AB D-Dimer Test Recall for 1,218 Units (2025)

Distribution without premarket approval/clearance.

GET TESTED INTERNATIONAL AB HbA1c Diabetes Test Recall Expands Nationwide (2025)

Distribution without premarket approval/clearance.

GET TESTED INTERNATIONAL AB Akkermansia Test Recalled for 24 Units (2025)

Distribution without premarket approval/clearance.

GET TESTED INTERNATIONAL AB Trichomonas Vaginalis Test Recalled for Lack of Premarket Approval (2025

Distribution without premarket approval/clearance.

GET TESTED INTERNATIONAL AB Recalls 6 Gut Microbiome Test Small Kits for Premarket Approval Violat​e

Distribution without premarket approval/clearance.

Philips IntelliVue MX100 Patient Monitors Recalled for Alarm Failure (Z-0861-2026)

Potential issue where the IntelliVue monitors did not alarm.

Modera Pack N Play Mattress Recall for Entrapment Risk in 2025

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 12-Inch Full-Size Mattress Recalled for Fire Hazard (2025)

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 Fabric Drawer Dressers Recall Expanded to 16-Drawer Models for Tip-Over Hazards (2025)

Kroger Recalls Halloween Skeleton Wax Candles for Fire Hazard (2025)

Philips Incisive CT Recall 2025: 2,341 CT Scanners Over Loose Tube Heat Exchanger Screws

B. Braun Medical SAFELINE IV Sets Recalled for 46,250 Units Over Backflow Risk (2025)

Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion).

Siemens Medical Solutions USA Recalls MAMMOMAT Inspiration Operator Table for Bus-Installation Risk

There were instances where the operator table was sold together with a bus-installation kit. The operator table is not intended and not released for bus installations as it was designed for stationary operation only.

Bealife 5-Drawer Dressers Recalled for Tip-Over Hazard in 2025

LEACHOI Adult Portable Bed Rails Recalled for Entrapment Risk (2025)

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 Recalls Pack-N-Stroll Premium Folding Utility Wagon for 2025 Entrapment and Falls Risk

WLIVE Fabric 12-Drawer Dressers Recalled for Tip-Over Risk (2025)

Belivium Baby Lounger Recall Expanded Over Suffocation and Entrapment Hazards (2025)

Calico Brands Recalls Scripto Premium Torch for Fire and Burn Hazard (2025)