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Showing 481–500 of 822 results

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

Distribution without premarket approval/clearance.

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.

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

Mack Granite (GR) (Mack) – Headlight Failure (2024)

Mack Trucks, Inc. (Mack) is recalling certain 2024-2025 Granite trucks equipped with LED headlights. The LED headlights may fail.

NHTSANov 3, 2025Nationwide• MACK

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

Distribution without premarket approval/clearance.

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

Organic Acids Profile Test Large (Get Tested International) – unapproved distribution (2025)

Distribution without premarket approval/clearance.

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

Estrogen & Progesterone Test (Get Tested International) – unapproved distribution (2025)

Distribution without premarket approval/clearance.

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

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

Distribution without premarket approval/clearance.

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

Chlamydia Test (GET TESTED INTERNATIONAL AB 59334 Vastervik Lysingsvagen 18 Vastervik Sweden) – distribution without premarket approv... (2025)

Distribution without premarket approval/clearance.

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

Linzer Hearts Cookies (Dough-To-Go) – Undeclared Milk (2025)

Undeclared Milk

Undeclared Milk and FD&C Blue #1.

FDANov 3, 2025TN• Dough-To-Go Inc

Allergy Test IgE (Get Tested International) – unapproved distribution (2025)

Distribution without premarket approval/clearance.

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.

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

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

Distribution without premarket approval/clearance.

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

Drug Test Small (Get Tested International) – unapproved distribution (2025)

Distribution without premarket approval/clearance.

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.

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

Food Intolerance Test Medium (Get Tested International) – unapproved distribution (2025)

Distribution without premarket approval/clearance.

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

Herpes (HSV-1 & HSV-2) Test (Get Tested International) – unapproved distribution (2025)

Distribution without premarket approval/clearance.

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

MPOX Test (GET TESTED INTERNATIONAL AB 59334 Vastervik Lysingsvagen 18 Vastervik Sweden) – distribution without premarket approv... (2025)

Distribution without premarket approval/clearance.

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

Food Intolerance Test Large (Get Tested International) – unapproved distribution (2025)

Distribution without premarket approval/clearance.

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

Organic Acids Test (Get Tested International) – unapproved distribution (2025)

Distribution without premarket approval/clearance.

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

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