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Showing 161–180 of 262 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

2 in 1 Trichomonas / Gardnerella 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

3 in 1 STI 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

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

Peptic Ulcer 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

Gut Microbiome 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

Gonorrhea 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

Pet Allergy 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

Sperm 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

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.

FDANov 3, 2025Nationwide• Fresenius Kabi USA, LLC

Lyme 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

Vitamin D2 and D3 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

Fructose 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

Lumify Diagnostic Ultrasound System (Philips) – iOS Compatibility Issue (2025)

Ultrasound system compatibility issues with Apple devices running iOS 18 may cause a failure to perform live imagining.

FDAOct 31, 2025Nationwide• Philips Ultrasound, LLC

IntelliVue Patient Monitor MX400 (Philips) – monitoring alarm issue (2025)

Potential issue where the IntelliVue monitors did not alarm.

FDAOct 31, 2025Nationwide• Philips North America Llc

IntelliVue Patient Monitor MX600 (Philips) – Alarm Failure Risk (2025)

Potential issue where the IntelliVue monitors did not alarm.

FDAOct 31, 2025Nationwide• Philips North America Llc

NICO BrainPath (Stryker) – latex packaging issue (2025)

Tape used to secure components within packaging contains latex, despite products being labeled as latex-free. Latex could potentially cause an allergic reaction.

FDAOct 31, 2025Nationwide• Stryker Corporation

Olympus OER-Pro (Aizu Olympus) – Maintenance Warning (2025)

Inform existing affected device customers about pertinent Warnings/Cautions, existing recommended maintenance schedules and that only properly trained personnel conduct repairs and maintenance.

FDAOct 31, 2025Nationwide• Aizu Olympus Co., Ltd. 3 Chome 1-1 Niiderakita Aizuwakamatsu Japan

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