Health & Personal Care
HIGH
FDA DEVICE
Cepheid Xpert MTB/RIF GXMTB/RIF-US-10 Recall Affects 9,880 Units in 2025
Product testing did not meet expected stability criteria.
Cepheid
Product testing
fda regulated Recalls
1,320 recalls tagged with “fda regulated”.
Health & Personal Care
HIGH
FDA DEVICE
Diasol Recalls Dialysis Concentrate Over Safety Concerns
Safety and efficacy of dialysis acid concentrate cannot be assured
Diasol
Safety and
Food & Beverages
HIGH
FDA FOOD
Africa Imports Recalls 31 Units of Organic Moringa Leaf Powder for Salmonella Risk (2025)
Product tested positive for Salmonella.
Africa Imports
Product tested
Health & Personal Care
HIGH
FDA DEVICE
GET TESTED INTERNATIONAL Gut Microbiome Test Large Recalled for Premarket-Approval Violation (2025)
Distribution without premarket approval/clearance.
GET TESTED INTERNATIONAL
Distribution without
Health & Personal Care
HIGH
FDA DEVICE
GET TESTED INTERNATIONAL AB Recalls 3 Food Sensitivity Test Small Units in 2025
Distribution without premarket approval/clearance.
GET TESTED INTERNATIONAL AB
Distribution without
Health & Personal Care
HIGH
FDA DEVICE
GET TESTED INTERNATIONAL AB Parasite Test Recalled for Distribution Without Premarket Approval
Distribution without premarket approval/clearance.
GET TESTED INTERNATIONAL AB
Distribution without
Health & Personal Care
HIGH
FDA DEVICE
GET TESTED INTERNATIONAL AB Thyroid TSH Test Recalled Over PMA Issue (1,916 Units)
Distribution without premarket approval/clearance.
GET TESTED INTERNATIONAL AB
Distribution without
Health & Personal Care
HIGH
FDA DEVICE
GET TESTED INTERNATIONAL AB Chlamydia Test Recall 2026 — 5 US Units Distributed, PMA Issue
Distribution without premarket approval/clearance.
GET TESTED INTERNATIONAL AB
Distribution without
Health & Personal Care
HIGH
FDA DEVICE
GET TESTED INTERNATIONAL AB Lyme Test Recalled for 940 Units in 2025
Distribution without premarket approval/clearance.
GET TESTED INTERNATIONAL AB
Distribution without
Health & Personal Care
HIGH
FDA DEVICE
Get Tested International AB 3 in 1 STI Test Recalled for Premarket Approval Issue (2025)
Distribution without premarket approval/clearance.
Get Tested International AB
Distribution without
Health & Personal Care
HIGH
FDA DEVICE
GET TESTED INTERNATIONAL AB Recalls Food Intolerance Test Due to Approval Issues
Distribution without premarket approval/clearance.
GET TESTED INTERNATIONAL AB
Distribution without
Health & Personal Care
HIGH
FDA DEVICE
GET TESTED INTERNATIONAL AB Issues Recall for Pet Allergy Test
GET TESTED INTERNATIONAL AB recalled 29 Pet Allergy Test units on November 3, 2025. The recall follows distribution without premarket approval. Patients and healthcare providers must stop using the device immediately.
GET TESTED INTERNATIONAL AB
Distribution without
Health & Personal Care
HIGH
FDA DEVICE
GET TESTED INTERNATIONAL AB Recalls 16 Food Intolerance Test Medium Devices (2025)
Distribution without premarket approval/clearance.
GET TESTED INTERNATIONAL AB
Distribution without
Health & Personal Care
HIGH
FDA DEVICE
GET TESTED INTERNATIONAL AB IgE Food Allergy Panel Test Recalled in 2025
Distribution without premarket approval/clearance.
GET TESTED INTERNATIONAL AB
Distribution without
Health & Personal Care
HIGH
FDA DEVICE
GET TESTED INTERNATIONAL AB Recalls 184 Menopause FSH Test Kits for Premarket Approval Issue (2025)
Distribution without premarket approval/clearance.
GET TESTED INTERNATIONAL AB
Distribution without
Health & Personal Care
HIGH
FDA DEVICE
GET TESTED INTERNATIONAL AB GI Microbiome Profile Small Recalled for Lack of Premarket Approval (202
Distribution without premarket approval/clearance.
GET TESTED INTERNATIONAL AB
Distribution without
Health & Personal Care
HIGH
FDA DEVICE
Orthofix Recalls PTC Spacer Systems Over Labeling Issues
Labeling contains claims that are not consistently present.
Orthofix U.S.
Labeling contains
Health & Personal Care
HIGH
FDA DEVICE
GET TESTED INTERNATIONAL AB Allergy Test Small Recalled for Lack of Premarket Approval (2025)
Distribution without premarket approval/clearance.
GET TESTED INTERNATIONAL AB
Distribution without
Health & Personal Care
HIGH
FDA DEVICE
GET TESTED INTERNATIONAL AB Heavy Metals Test Recall for 50 Units (2025)
Distribution without premarket approval/clearance.
GET TESTED INTERNATIONAL AB
Distribution without
Health & Personal Care
LOW
FDA DEVICE
GET TESTED INTERNATIONAL AB Intestinal Worms Test Recalled for 45 Units Nationwide in 2025
Distribution without premarket approval/clearance.
GET TESTED INTERNATIONAL AB
Distribution without
Tag Statistics
Total Recalls
1,320