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FDA Recalls
›Device Recalls

FDA Device Recalls

Recalls of medical devices, diagnostic equipment, implants, and surgical instruments.

Classification

All Class I Class II Class III

Status

All Ongoing Completed Terminated

Date

All time Past 30 days Past 12 months

Showing 1801–1820 of 39,430 recalls

Class IIOngoing

Herpes (HSV-1 & HSV-2) Test

GET TESTED INTERNATIONAL AB

Distribution without premarket approval/clearance.

November 3, 2025 · DeviceView details →

Class IIOngoing

Iron Deficiency Test

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Distribution without premarket approval/clearance.

November 3, 2025 · DeviceView details →

Class IIOngoing

Diabetes Test (ketones & glucose)

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Distribution without premarket approval/clearance.

November 3, 2025 · DeviceView details →

Class IIOngoing

Liver Test

GET TESTED INTERNATIONAL AB

Distribution without premarket approval/clearance.

November 3, 2025 · DeviceView details →

Class IIOngoing

Pregnancy Test

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Distribution without premarket approval/clearance.

November 3, 2025 · DeviceView details →

Class IIOngoing

Allergy & Food Intolerance Test

GET TESTED INTERNATIONAL AB

Distribution without premarket approval/clearance.

November 3, 2025 · DeviceView details →

Class IIOngoing

Ovulation Test (5 tests)

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Distribution without premarket approval/clearance.

November 3, 2025 · DeviceView details →

Class IIOngoing

Food Sensitivity Test Medium

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Distribution without premarket approval/clearance.

November 3, 2025 · DeviceView details →

Class IIOngoing

Men s Hormone Test

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Distribution without premarket approval/clearance.

November 3, 2025 · DeviceView details →

Class IIOngoing

H pylori (Peptic ulcer) Test

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Distribution without premarket approval/clearance.

November 3, 2025 · DeviceView details →

Class IIOngoing

Neurotransmitters Basic

GET TESTED INTERNATIONAL AB

Distribution without premarket approval/clearance.

November 3, 2025 · DeviceView details →

Class IIOngoing

Epstein-Barr Virus (EBV VCA & EBNA IgG) Test

GET TESTED INTERNATIONAL AB

Distribution without premarket approval/clearance.

November 3, 2025 · DeviceView details →

Class IIOngoing

Fecal Occult Blood Test

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Distribution without premarket approval/clearance.

November 3, 2025 · DeviceView details →

Class IIOngoing

Women s Hormone Test

GET TESTED INTERNATIONAL AB

Distribution without premarket approval/clearance.

November 3, 2025 · DeviceView details →

Class IIOngoing

Melatonin Test

GET TESTED INTERNATIONAL AB

Distribution without premarket approval/clearance.

November 3, 2025 · DeviceView details →

Class IIIOngoing

Brand Name: FIREBIRD" SI Fusion System Product Name: FIREBIRD" SI Fusion System Model/Catalog Number: 18-1025SP 11mm X 25mm FIREBIRD SI Screw; 18-1030SP 11mm X 30mm FIREBIRD SI Screw; 18-1035SP 11mm X 35mm FIREBIRD SI Screw; 18-1040SP 11mm X 40mm FIREBIRD SI Screw; 18-1045SP 11mm X 45mm FIREBIRD SI Screw; 18-1050SP 11mm X 50mm FIREBIRD SI Screw; 18-1055SP 11mm X 55mm FIREBIRD SI Screw; 18-1060SP 11mm X 60mm FIREBIRD SI Screw; 18-1065SP 11mm X 65mm FIREBIRD SI Screw; 18-1070SP 11mm X 70mm FIREBIRD SI Screw; 18-2025SP 12mm X 25mm FIREBIRD SI Screw; 18-2030SP 12mm X 30mm FIREBIRD SI Screw; 18-2035SP 12mm X 35mm FIREBIRD SI Screw; 18-2040SP 12mm X 40mm FIREBIRD SI Screw; 18-2045SP 12mm X 45mm FIREBIRD SI Screw; 18-2050SP 12mm X 50mm FIREBIRD SI Screw; 18-2055SP 12mm X 55mm FIREBIRD SI Screw; 18-2060SP 12mm X 60mm FIREBIRD SI Screw; 18-2065SP 12mm X 65mm FIREBIRD SI Screw; 18-2070SP 12mm X 70mm FIREBIRD SI Screw

Orthofix U.S. LLC

Labeling contains claims that are not consistently present.

November 3, 2025 · DeviceView details →

Class IIOngoing

Neurotransmitters XL

GET TESTED INTERNATIONAL AB

Distribution without premarket approval/clearance.

November 3, 2025 · DeviceView details →

Class IIOngoing

IBS Test

GET TESTED INTERNATIONAL AB

Distribution without premarket approval/clearance.

November 3, 2025 · DeviceView details →

Class IIOngoing

Sorbitol Intolerance Test

GET TESTED INTERNATIONAL AB

Distribution without premarket approval/clearance.

November 3, 2025 · DeviceView details →

Class IIOngoing

Environmental Pollutants Profile Test

GET TESTED INTERNATIONAL AB

Distribution without premarket approval/clearance.

November 3, 2025 · DeviceView details →

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