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Showing 501–520 of 35905 results

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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

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

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.

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

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

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

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

Distribution without premarket approval/clearance.

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.

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.

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.

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

Allergy 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

Continuous Glucose Monitor (Get Tested International) – unapproved distribution (2025)

Distribution without premarket approval/clearance.

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

Allergy & Food 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

ViewPoint 6 (GE Healthcare) – incomplete patient history (2025)

GE HealthCare has become aware that the Patient History tab in ViewPoint 6 versions 6.15.3 and 6.15.4 ultrasound software may not include complete patient medical history information.

FDANov 3, 2025Nationwide• GE Healthcare GmbH Oskar-Schlemmer-Str. 11 Munich Germany

Hair Mineral Analysis (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

Pillar SA PTC Spacer System (Orthofix) – inconsistent labeling (2025)

Labeling contains claims that are not consistently present.

FDANov 3, 2025Nationwide• Orthofix U.S. 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 Myriad Illumination Pack (Stryker) – Latex Contamination Risk (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

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