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Showing 421–440 of 5023 results

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Alcohol Test Saliva (Get Tested International) – unapproved distribution (2025)

Distribution without premarket approval/clearance.

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

Trichomonas Vaginalis 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

Men s Hormone 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

Volvo VNL (4) (Volvo) – Roof Marker Light Failure (2026)

Volvo Trucks North America (Volvo Trucks) is recalling certain 2026 New VN trucks. The roof center marker lights may fail to illuminate. As such, these vehicles fail to comply with the requirements of Federal Motor Vehicle Safety Standard number 108, "Lamps, Reflective Devices, and Associated Equipment."

NHTSANov 3, 2025Nationwide• VOLVO

Intestinal Worms 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

Cholesterol 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

Menopause 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

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

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

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

Volvo VAH (Volvo) – Seat Belt Anchorage Defect (2026)

Volvo Trucks North America (Volvo Trucks) is recalling certain 2019-2026 VAH trucks. The passenger seat belt anchor may fail due to inadequate floor reinforcement. As such, these vehicles fail to comply with the requirements of Federal Motor Vehicle Safety Standard number 210, "Seat Belt Assembly Anchorages."

NHTSANov 3, 2025Nationwide• VOLVO

Melatonin 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

D-Dimer 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

Pollen Allergy 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

H Pylori 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

Liver 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

Sorbitol Intolerance 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

Brand Name: CONSTRUX" Mini PTC Spacer System Product Name... (Orthofix U.S. LLC) – labeling contains claims that are not... (2025)

Labeling contains claims that are not consistently present.

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

Epstein-Barr Virus 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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