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New York

Product Recalls in New York

All product recalls affecting New York.

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

Get alerts for New York

Showing 461–480 of 34319 recalls

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

Distribution without premarket approval/clearance.

High

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

Food Allergy Panel Test (Get Tested International) – unapproved distribution (2025)

Distribution without premarket approval/clearance.

High

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

Women s Hormone Test (Get Tested International) – unapproved distribution (2025)

Distribution without premarket approval/clearance.

High

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

NAD Profile Test (Get Tested International) – unapproved distribution (2025)

Distribution without premarket approval/clearance.

High

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

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

Distribution without premarket approval/clearance.

High

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

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

Distribution without premarket approval/clearance.

High

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

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

Distribution without premarket approval/clearance.

High

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

Vitamin D2 and D3 Test (Get Tested International) – unapproved distribution (2025)

Distribution without premarket approval/clearance.

High

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

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

Distribution without premarket approval/clearance.

High

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

IVENIX Infusion System (Fresenius Kabi) – incorrect assembly (2025)

Incorrect assembly of specific lot of LVP Primary Administration Set that could result in serious patient injury.

High

FDANov 3, 2025Nationwide• Fresenius Kabi USA, LLC

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

Distribution without premarket approval/clearance.

High

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

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

Distribution without premarket approval/clearance.

High

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

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

Distribution without premarket approval/clearance.

High

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

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

Distribution without premarket approval/clearance.

High

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

Peptic Ulcer Test (Get Tested International) – unapproved distribution (2025)

Distribution without premarket approval/clearance.

High

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

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

Distribution without premarket approval/clearance.

High

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

Illegally Marketed (Get Tested International) – unapproved distribution (2025)

Distribution without premarket approval/clearance.

High

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

Urinary Tract Infection Test (Get Tested International) – unapproved distribution (2025)

Distribution without premarket approval/clearance.

High

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.

High

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

Vitamin D-Test (Get Tested International) – unapproved distribution (2025)

Distribution without premarket approval/clearance.

High

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

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