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Medical Devices

Medical Devices Recalls

Medical device and health technology recalls from FDA. Includes diagnostic equipment, implants, monitors, and therapeutic devices.

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Showing 101–120 of 8393 recalls

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H Pylori Test (Get Tested International) – unapproved distribution (2025)

Distribution without premarket approval/clearance.

Moderate

FDANov 3, 2025Nationwide• GET TESTED INTERNATIONAL AB 59334 Vastervik Lysingsvagen 18 Vastervik Sweden

Liver Test (Get Tested International) – unapproved distribution (2025)

Distribution without premarket approval/clearance.

Moderate

FDANov 3, 2025Nationwide• GET TESTED INTERNATIONAL AB 59334 Vastervik Lysingsvagen 18 Vastervik Sweden

Sorbitol Intolerance Test (Get Tested International) – unapproved distribution (2025)

Distribution without premarket approval/clearance.

Moderate

FDANov 3, 2025Nationwide• GET TESTED INTERNATIONAL AB 59334 Vastervik Lysingsvagen 18 Vastervik Sweden

Lactose Intolerance Test (Get Tested International) – unapproved distribution (2025)

Distribution without premarket approval/clearance.

Moderate

FDANov 3, 2025Nationwide• GET TESTED INTERNATIONAL AB 59334 Vastervik Lysingsvagen 18 Vastervik Sweden

Epstein-Barr Virus Test (Get Tested International) – unapproved distribution (2025)

Distribution without premarket approval/clearance.

Moderate

FDANov 3, 2025Nationwide• GET TESTED INTERNATIONAL AB 59334 Vastervik Lysingsvagen 18 Vastervik Sweden

Cholesterol Test (Get Tested International) – unapproved distribution (2025)

Distribution without premarket approval/clearance.

Moderate

FDANov 3, 2025Nationwide• GET TESTED INTERNATIONAL AB 59334 Vastervik Lysingsvagen 18 Vastervik Sweden

Gut Microbiome Test Mega (Get Tested International) – unapproved distribution (2025)

Distribution without premarket approval/clearance.

Moderate

FDANov 3, 2025Nationwide• GET TESTED INTERNATIONAL AB 59334 Vastervik Lysingsvagen 18 Vastervik Sweden

Mycoplasma Test (Get Tested International) – unapproved distribution (2025)

Distribution without premarket approval/clearance.

Moderate

FDANov 3, 2025Nationwide• GET TESTED INTERNATIONAL AB 59334 Vastervik Lysingsvagen 18 Vastervik Sweden

CONSTRUX Mini Ti Spacer System (Orthofix) – inconsistent labeling (2025)

Labeling contains claims that are not consistently present.

Moderate

FDANov 3, 2025Nationwide• Orthofix U.S. LLC

Blood Type Test (Get Tested International) – unapproved distribution (2025)

Distribution without premarket approval/clearance.

Moderate

FDANov 3, 2025Nationwide• GET TESTED INTERNATIONAL AB 59334 Vastervik Lysingsvagen 18 Vastervik Sweden

Neurotransmitters XL (Get Tested International) – unapproved distribution (2025)

Distribution without premarket approval/clearance.

Moderate

FDANov 3, 2025Nationwide• GET TESTED INTERNATIONAL AB 59334 Vastervik Lysingsvagen 18 Vastervik Sweden

8 in 1 STI Test Kit (Get Tested International) – unapproved distribution (2025)

Distribution without premarket approval/clearance.

Moderate

FDANov 3, 2025Nationwide• GET TESTED INTERNATIONAL AB 59334 Vastervik Lysingsvagen 18 Vastervik Sweden

Pregnancy Test (Get Tested International) – unapproved distribution (2025)

Distribution without premarket approval/clearance.

Moderate

FDANov 3, 2025Nationwide• GET TESTED INTERNATIONAL AB 59334 Vastervik Lysingsvagen 18 Vastervik Sweden

GI Microbiome Profile Small (Get Tested International) – unapproved distribution (2025)

Distribution without premarket approval/clearance.

Moderate

FDANov 3, 2025Nationwide• GET TESTED INTERNATIONAL AB 59334 Vastervik Lysingsvagen 18 Vastervik Sweden

IBS Test (Get Tested International) – unapproved distribution (2025)

Distribution without premarket approval/clearance.

Moderate

FDANov 3, 2025Nationwide• GET TESTED INTERNATIONAL AB 59334 Vastervik Lysingsvagen 18 Vastervik Sweden

Heavy Metals Test (Get Tested International) – unapproved distribution (2025)

Distribution without premarket approval/clearance.

Moderate

FDANov 3, 2025Nationwide• GET TESTED INTERNATIONAL AB 59334 Vastervik Lysingsvagen 18 Vastervik Sweden

Leaky Gut Test (Get Tested International) – unapproved distribution (2025)

Distribution without premarket approval/clearance.

Moderate

FDANov 3, 2025Nationwide• GET TESTED INTERNATIONAL AB 59334 Vastervik Lysingsvagen 18 Vastervik Sweden

PSA Test (Get Tested International) – unapproved distribution (2025)

Distribution without premarket approval/clearance.

Moderate

FDANov 3, 2025Nationwide• GET TESTED INTERNATIONAL AB 59334 Vastervik Lysingsvagen 18 Vastervik Sweden

Serotonin Test (Get Tested International) – unapproved distribution (2025)

Distribution without premarket approval/clearance.

Moderate

FDANov 3, 2025Nationwide• GET TESTED INTERNATIONAL AB 59334 Vastervik Lysingsvagen 18 Vastervik Sweden

Ovulation Test (Get Tested International) – unapproved distribution (2025)

Distribution without premarket approval/clearance.

Moderate

FDANov 3, 2025Nationwide• GET TESTED INTERNATIONAL AB 59334 Vastervik Lysingsvagen 18 Vastervik Sweden

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