
mandatory standard violation Recalls
147 recalls tagged with “mandatory standard violation”.



Belkin Recalls 3 Models of Power Banks and Charging Stands for Fire Hazard (2025)
Olympus Sheath Recalled Over Risk of Ceramic Tip Breakage
Complaints of the ceramic tip of the resection sheath breaking have been received.

Criblike Pack and Play and Mini-Crib Mattresses Recalled for Entrapment Risk (2025)

WYBITNY Bed Rails Recalled for Entrapment Risk in 2025 Recall
WYBITNY recalled bed rails sold on Amazon due to an entrapment risk. The product features a white metal frame and dark gray fabric cushions labeled BGRT003. Consumers should stop using the recalled bed rails and request a full refund.

GET TESTED INTERNATIONAL AB Peptic Ulcer Test Recalled 12 Units in 2025
Distribution without premarket approval/clearance.
Get Tested International AB 3 in 1 STI Test Recalled for Premarket Approval Issue (2025)
Distribution without premarket approval/clearance.
GET TESTED INTERNATIONAL Gut Microbiome Test Large Recalled for Premarket-Approval Violation (2025)
Distribution without premarket approval/clearance.
GET TESTED INTERNATIONAL AB Thyroid TSH Test Recalled Over PMA Issue (1,916 Units)
Distribution without premarket approval/clearance.
GET TESTED INTERNATIONAL AB 8 in 1 STI Test Kit Recalled for 2,043 Units in 2025
Distribution without premarket approval/clearance.
Get Tested International AB Leaky Gut Test Recalled for Lack of FDA Approval (31 Units)
Distribution without premarket approval/clearance.
GET TESTED INTERNATIONAL AB NAD Profile Test Recall 36 Units for Premarket Approval Issue (2025)
Distribution without premarket approval/clearance.
GET TESTED INTERNATIONAL AB Serotonin Test Recall 12 Units (2025)
Distribution without premarket approval/clearance.
GET TESTED INTERNATIONAL AB MPOX Test Recall for 4 Units Distributed in US (2025)
Distribution without premarket approval/clearance.
GET TESTED INTERNATIONAL AB Candida Test Recalled for 166 Units in 2025
Distribution without premarket approval/clearance.
GET TESTED INTERNATIONAL AB Recalled 4 Organic Acids Test Kits for Distribution Without Premarket |
Distribution without premarket approval/clearance.
GET TESTED INTERNATIONAL AB Intestinal Worms Test Recalled for 45 Units Nationwide in 2025
Distribution without premarket approval/clearance.
GET TESTED INTERNATIONAL AB Recalls 16 Food Intolerance Test Medium Devices (2025)
Distribution without premarket approval/clearance.