Candida Test
GET TESTED INTERNATIONAL AB
Class I - Dangerous
Distribution without premarket approval/clearance.
ðĨ
Medical Devices Recalls
Medical equipment, implants, and diagnostic devices
37,779 Total Recalls
Organic Acids Profile Test Large
GET TESTED INTERNATIONAL AB
Class I - Dangerous
Distribution without premarket approval/clearance.
Allergy Test IgE
GET TESTED INTERNATIONAL AB
Class I - Dangerous
Distribution without premarket approval/clearance.
Allergy test Small
GET TESTED INTERNATIONAL AB
Class I - Dangerous
Distribution without premarket approval/clearance.
IntelliVue Patient Monitor MX800. Product Number: 865240.
Philips North America
Class I - Dangerous
Potential issue where the IntelliVue monitors did not alarm.
GI Microbiome Profile XL
GET TESTED INTERNATIONAL AB
Class I - Dangerous
Distribution without premarket approval/clearance.
Illegally Marketed
GET TESTED INTERNATIONAL AB
Class I - Dangerous
Distribution without premarket approval/clearance.
HPV Antigen Test
GET TESTED INTERNATIONAL AB
Class I - Dangerous
Distribution without premarket approval/clearance.
Lumify Diagnostic Ultrasound System models : 795005, 795161, 989605449841,
Philips Ultrasound
Class I - Dangerous
Ultrasound system compatibility issues with Apple devices running iOS 18 may cause a failure to perform live imagining.
Sperm Test
GET TESTED INTERNATIONAL AB
Class I - Dangerous
Distribution without premarket approval/clearance.
Mycoplasma test, IgG and IgM
GET TESTED INTERNATIONAL AB
Class I - Dangerous
Distribution without premarket approval/clearance.
Parasite Test
GET TESTED INTERNATIONAL AB
Class I - Dangerous
Distribution without premarket approval/clearance.
Adrenal Test
GET TESTED INTERNATIONAL AB
Class I - Dangerous
Distribution without premarket approval/clearance.
Neurotransmitters Plus
GET TESTED INTERNATIONAL AB
Class I - Dangerous
Distribution without premarket approval/clearance.
Welch Allyn INF BAG, Thigh 1-Tube, Model/Catalog Number: REF 5089-18; Product replacement bladder for the Welch Allyn Two-Piece Blood Pressure Cuff.
Baxter Healthcare
Class I - Dangerous
Replacement bladder kit for the Welch Allyn two-piece reusable blood pressure cuff may contain a Large Adult size bladder rather than a Thigh size bladder in the replacement kits.
Pollen Allergy Test
GET TESTED INTERNATIONAL AB
Class I - Dangerous
Distribution without premarket approval/clearance.
Ivenix Infusion System (IIS), Large Volume Pump. Model Number: LVP-0004.
Fresenius Kabi USA
Class I - Dangerous
Downstream Occlusion alarms may occur during procedures using low flow infusion rates when a check valve* is added to the Ivenix Administration Set.
Alcohol (ALC) Test Saliva
GET TESTED INTERNATIONAL AB
Class I - Dangerous
Distribution without premarket approval/clearance.
Gut Microbiome Test XL
GET TESTED INTERNATIONAL AB
Class I - Dangerous
Distribution without premarket approval/clearance.
Pet Allergy Test
GET TESTED INTERNATIONAL AB
Class I - Dangerous
Distribution without premarket approval/clearance.