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North Carolina

Product Recalls in North Carolina

All product recalls affecting North Carolina.

Includes nationwide recalls (tagged “Nationwide”) and recalls with North Carolina in the distribution area.

Get alerts for North Carolina

Showing 401–420 of 34283 recalls

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

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

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

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

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

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

FORZA PTC Spacer System (Orthofix) – inconsistent labeling (2025)

Labeling contains claims that are not consistently present.

Low

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

Gut Microbiome Test 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

HPV Antigen 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

Biological Age & Longevity 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

Environmental Pollutants Profile 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

Vaginal PH 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

Iron Deficiency 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

Ivenix Infusion System (Fresenius Kabi) – downstream occlusion (2025)

Downstream Occlusion alarms may occur during procedures using low flow infusion rates when a check valve* is added to the Ivenix Administration Set.

Moderate

FDANov 3, 2025Nationwide• Fresenius Kabi USA, LLC

Diabetes HbA1c 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

Food Intolerance Test 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

Female Fertility 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

FIREBIRD SI Fusion System (Orthofix) – inconsistent labeling (2025)

Labeling contains claims that are not consistently present.

Low

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

Thyroid TSH 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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